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PLOS ONE logoLink to PLOS ONE
. 2021 Feb 22;16(2):e0247409. doi: 10.1371/journal.pone.0247409

“Dispense antiretrovirals daily!” restructuring the delivery of HIV services to optimize antiretroviral initiation among men in Malawi

Alinane Linda Nyondo-Mipando 1,*, Leticia Suwedi Kapesa 1, Sangwani Salimu 1, Thokozani Kazuma 1, Victor Mwapasa 2
Editor: Jeremiah Chikovore3
PMCID: PMC7899340  PMID: 33617561

Abstract

Background

Gender disparities exist in the scale-up and uptake of HIV services with men being disproportionately under-represented in the services. In Eastern and Southern Africa, of the people living with HIV infection, more adult women than men were on treatment highlighting the disparities in HIV services. Delayed initiation of antiretroviral treatment creates a missed opportunity to prevent transmission of HIV while increasing HIV and AIDS-associated morbidity and mortality. The main objective of this study was to assess the strategies that men prefer for Antiretroviral Therapy (ART) initiation in Blantyre, Malawi.

Methods

This was a qualitative study conducted in 7 Health facilities in Blantyre from January to July 2017. We selected participants following purposive sampling. We conducted 20 in-depth interviews (IDIs) with men of different HIV statuses, 17 interviews with health care workers (HCWs), and 14 focus group discussions (FGDs) among men of varying HIV statuses. We digitally recorded all the data, transcribed verbatim, managed using NVivo, and analysed it thematically.

Results

Restructuring the delivery of antiretroviral (ARVs) treatment and conduct of ART clinics is key to optimizing early initiation of treatment among heterosexual men in Blantyre. The areas requiring restructuring included: Clinic days by offering ARVs daily; Clinic hours to accommodate schedules of men; Clinic layout and flow that preserves privacy and establishment of male-specific clinics; ARV dispensing procedures where clients receive more pills to last them longer than 3 months. Additionally there is need to improve the packaging of ARVs, invent ARVs with less dosing frequency, and dispense ARVs from the main pharmacy. It was further suggested that the test-and-treat strategy be implemented with fidelity and revising the content in counseling sessions with an emphasis on the benefits of ARVs.

Conclusion

The success in ART initiation among men will require a restructuring of the current ART services to make them accessible and available for men to initiate treatment. The inclusion of people-centered approaches will ensure that individual preferences are incorporated into the initiation of ARVs. The type, frequency, distribution, and packaging of ARVs should be aligned with other medicines readily available within a health facility to minimize stigma.

Introduction

Gender disparities continue to exist in the scale-up and uptake of Human Immunodeficiency Virus (HIV) services with men disproportionately represented in accessing the services [1]. Although heterosexual men are active transmitters of HIV infection, they are regarded as less vulnerable to HIV with limited attention in preventive efforts and policies [2, 3] and at best have been stereotyped as the ones that spread the virus [4]. Despite the limited attention that heterosexual men receive concerning HIV services, heterosexual transmission remains the primary mode of contracting HIV in Sub-Saharan Africa (SSA) [5]. Although several studies have documented the benefits of starting ARVs early regardless of Cluster of Differentiation 4 (CD4) count [68], men have lagged in the uptake of Antiretrovirals in SSA [9, 10]. The recent trends in Malawi also show a similar pattern where 92% of HIV-infected women were on treatment while men lagged at 76% [10]. As illustrated in several studies, men tend to access HIV services at a late stage [1113] and consequently delay initiating ARVs [14]. A delay in the initiation of ARVs creates a missed opportunity to prevent transmission of HIV [12] and increases the mortality rate in men consequent to initiating ART in an advanced AIDS state [11, 15].

Among the factors contributing to low uptake of ART services by men is poor knowledge of the availability of services, perception of having a low risk [16] limited avenues for HIV services for men [17], fear of discrimination, stigma, and rejection, and [18] notions of masculinity that present men as resilient to illness [19]. Furthermore, the health system has been criticized for being uninviting to people living with HIV which is compounded by its structures that are authoritarian in the delivery of services [20]. Additionally, it has been argued that the services are biased towards females [21] which has resulted in limited services for men. The services that are available for men have primarily focused on men having sex with men leaving out the general population of men [22, 23].

Several strategies have been proposed to address inequalities among men. Shand et al. [24] advocate for challenging the patriarchal structures that contribute to the notion of resilience among men which makes them seek medical services late. New strategies within the health system that aim at optimizing service delivery to various clients are called Differentiated Service Delivery (DSD) models. Differentiated Service Delivery models are advocated as a framework for health systems to deliver services that consider the user’s preference [25, 26]. Key to the DSD models are the four tenets that can be applied and these include a variation in the types of services provided, varied locations where the service will be provided, a range of health care workers providing the service, and the frequency of services provided [25]. Each tenet addresses a specific need that a client may prefer for accessing ARVs [25]. The main advantage of DSD models is that they optimize usage of the limited number of staff available in fragile health systems [27]. Differentiated Service Delivery models are cost-efficient [28, 29] and also reduce the need for more personnel [29].

Malawi adopted the DSD models in the delivery of HIV services in 2008 to optimize the delivery of HIV-related services [28]. HIV and ART services in Malawi are provided for free in all Government-owned health facilities and at a cost in private and faith-based organisations. The services include HIV testing, ART initiation, and follow-up in care. Health facilities in the urban areas offer HIV services daily while those in semi-urban and rural areas have a designated day within the week when ART clinics are run while HIV testing is offered daily. Malawi has integrated the delivery of HIV services with Tuberculosis, Family planning, and Sexual and reproductive health programmes [30]. All services are standardized and follow the same monitoring plan regardless of their location and rarely do facilities experience stock-outs of ARVs [31]. At the point of ART initiation, a client is supposed to nominate a person who is commonly referred to as a “guardian” who is usually a layperson and could be a friend or family member [32]. A guardian is counseled along with a client on the HIV status of the client and information on ARVs to promote adherence and at times to collect the ARVs on behalf of the client [32]. Despite the lag in men accessing HIV services, there have been no specific HIV service programmes rolled out for men in Malawi. However, anecdotal reports show that some health implementing partners piloted male-friendly clinic services in 12 primary health facilities in Blantyre, Malawi, in 2018, a year after we had finalized data collection [33]. The male-friendly clinics would open once a week on Saturday’s targeting newly diagnosed men and those that had problems collecting ARVs during the week [33]. Male- friendly clinics were run by both female and male health care workers providing non-communicable health services, sexually transmitted infection services, HIV testing services, and ARVs dispensation [33]. Seeing that men have lagged in ART initiation, this study assessed strategies that men prefer for ART initiation in Blantyre, Malawi.

Methods

Study design

We conducted a descriptive qualitative study to assess strategies that men prefer for ART initiation in Blantyre, Malawi. We used In-Depth Interviews (IDIs), Key Informant Interviews (KIIs) [34, 35], and Focus Group Discussions (FGDs) [36]. We opted for IDIs because of the depth they guarantee in understanding a social phenomenon [34]. We used FGDs to stimulate varying responses from men secondary to the interactions within a group [37] and we employed aspects of a phenomenological approach by including men who have interacted with HIV services.

Study setting

The study took place in Government-owned facilities and included six health centres and a tertiary hospital in Blantyre District in the southern part of Malawi. Of the six health centres; two are located in a rural area, two are in an urban area and the other two are in the semi-urban area. The two urban health centres are located in high densely populated areas in Blantyre city [40]. We also purposively selected the tertiary hospital because it is the main referral centre for Blantyre district and Southern Malawi. Blantyre district has the highest prevalence rate of HIV among men rate at 14 as of 2016 [38] which translates into more men needing ARVs.

Sample size

We purposively [39] sampled our participants and included 20 men in IDIs and these were of the unknown, infected, and uninfected HIV statuses. We conducted 17 KIIs with Health Care Workers (HCWs) involved in the provision of HIV services at various intervals of HIV care and these included HIV Diagnostic Assistants (HDAs), HIV Testing Services Providers, Medical Assistants, Clinical Officers, and Nurses. We also conducted 14 FGDs with men and we had 2 FGDs at each site. Our sample size was adequately guided by Guest who contends that saturation is mostly reached by the 12th interview [40]. The FGDs were divided according to age and translated into one FGD with younger men with an age bracket of 18–24 years and the other with older men with an age bracket of 25 years and above at each site. The FGDs were segregated according to age to promote participation which could have been limited if we had combined younger and older men in one group [37]. In total, we had 113 men in the FGDs. We included men of various demographics such as age, residency, education level, marital status, religion, occupation, and HIV status in our sampled participants, to achieve maximum variation so as to broaden the scope of the sources of information in our study [42].

Identification, recruitment, and selection of study participants

Identification of health care workers

After explaining the study and the eligibility criteria, the Officer In-charge assisted with the identification of health care workers and the selection was based on their role in the provision of HIV services to men. For the HCWs, we included only those that had provided ART services for more than 6 months at the selected site and were available and willing to participate in the study. The Blantyre District Health Office (DHO) referred us to the Blantyre District’s HIV and ART Coordinators for inclusion in the study. None of the health care workers approached refused participation in the study.

Identification of participants for in-depth interviews

We purposively identified men for in-depth interviews following the study’s eligibility criteria. We included heterosexual men (as ascertained by asking them their sexual orientation) who were 18 years of age and above, able and willing to provide consent, and of a range of HIV statuses: uninfected (confirmed through checking the health passport books), unknown (ascertained by asking if they have ever tested for HIV or not), and HIV infected on ART and not on ART (confirmed through checking the health passport book and/or clinic records). If a man was interested in the study we either booked an appointment with him on a later date or if flexible study procedures were conducted after completion of the primary aim for visiting the health facility. Participants who were not on ARVs were identified with assistance from health care workers who introduced them to research staff. Five participants that were approached refused participation and cited time constraints and lack of interest in the study as the reasons for non-participation.

Identification of participants for focus group discussions

We identified participants for FGDs with assistance from HCWs following the eligibility criteria. We included men that were 18 years and above, varying HIV status, on ARVs and not on ARVs, able to provide consent, and willing to participate in the study. Men were scheduled for a discussion at a time and place convenient for them. Seven participants that were approached refused participation and cited time constraints as the reason for non-participation.

Data collection

We collected data from January to July 2017 using pretested interview and discussion guides that were developed based on the study objectives and literature. All interviews and discussions were conducted once-off per participant or discussants respectively. With the exception of VM, all authors conducted interviews and all data collectors were female. Before data collection, ALNM, the Principal Investigator (PI), trained the team on the study protocol, procedures, research ethics, and logistics of the study. LSK and SS are public health specialists with Masters in Public health. TK has a Bachelor of Nursing and Midwifery and ALNM has a PH.D. in Health Systems and Policy. LSK was working as a Nursing Officer at the time of data collection, SS and TK were Research Assistants in the project and ALNM worked with the College of Medicine. There was no prior relationship with the participants and the data collectors introduced themselves as research assistants on the project while ALNM introduced herself as the Principal Investigator for the study. The study participants were informed that the rationale for conducting the study was to generate strategies for improving the initiation of ART among men in Malawi. All interviews and discussions were face-to-face and were conducted at a place and time convenient to the participants. All FGDs, KIIs, and IDIs were conducted at the respective health facilities except those of the ART and HIV Testing Coordinator which were conducted in their offices. The broad questions that guided the interviews and discussions for both men and health care workers were as follows:

  1. Explain to me in detail the avenues or methods that can be used to increase early antiretroviral initiation among men at this facility and other areas?

  2. Amongst the suggested strategies or avenues you have mentioned, which one would be most preferred by men [you] for early initiation of ARVs and why?

After a response, we probed further to capture more depth on the subject. Interviews and discussions with men were conducted in Chichewa while key informant interviews were deliberated in both English and Chichewa as per participant’s preference. We captured all deliberations using a digital audio recorder and each recorded interview was assigned a unique identification number. During the interviews and discussions, we captured field notes that supplemented the audio recordings [41]. All audio records and completed transcripts were stored on a password-protected computer. We probed deeply on each response to ensure we covered adequate depth and scope on an issue. We conducted the interviews and discussion in the language a participant preferred in order to eliminate the language barrier which would compromise our findings. Each interview lasted for 30–45 minutes while FGDs lasted for about 60–90 minutes. Our decision to stop data collection was guided by the concept of saturation of ideas which was reached when we noted the absence of new ideas and responses from participants. We conducted and reported our study following the consolidated criteria for reporting qualitative research (COREQ) guidelines [42].

Quality of data

We applied several measures to maximize the quality of our findings. We summarized the key findings after each interview or discussion to ensure that our findings are credible [43]. We described the methods used in conducting the study to ensure that our findings are dependable [43]. Furthermore we have provided a rich description of the setting and context where we conducted the study to make our results transferable to other areas [44].

Data analysis

We used NVivo to manage our data and employed a thematic analysis approach as outlined by Braun and Clarke [45]. Data analysis commenced during the data collection period. All audio recordings from interviews and discussions were transcribed verbatim and simultaneously translated if the interview was not done in English. Codes were generated, deductively, from the objectives of the study and also, inductively, from the data [46]. First, the Principal Investigator listened to the audios and read the transcripts multiple times to gain a deeper understanding of the issues raised. Secondly, a codebook was generated and discussed among the research team for consensus. ALMN and SS independently coded separate transcripts to assess the applicability of codes. Any areas of disagreement were resolved through iterative discussions between ALNM and SS [45]. Thirdly, SS coded all the transcripts, and as she coded she constantly discussed with ALNM the new codes to be added and any proposed changes to the codebook. Our three main themes were realized through the collation of similar, related, and recurrent codes, specifically, we grouped all codes on drugs such as dispensation, composition, packaging, and innovations under one overarching theme of differentiating drug dispensing modalities; all codes related to clinic flow, layout and hours and days of operation of a facility were aggregated under Differentiated clinic operations and all codes that referred to the implementation of test-and-treat and counseling were grouped under the strengthening implementation of available policies theme. Fourthly, the research team reviewed the themes and refined them as appropriate to achieve a correct representation of our findings [47]. Lastly, we reviewed the themes to ensure that they correctly represented the data under them without losing the meaning of the data.

Ethical considerations

Our study obtained ethical approval from Malawi’s College of Medicine Research and Ethics Committee (COMREC- Number P.11/16/2064) before study implementation. The District of Health and Social Services (DHSS) for Blantyre and the Director of (Queen Elizabeth Central Hospital (QECH) provided Institutional support for the study to take place in the respective sites. Each study participant provided written informed consent before any study procedures. Participants that could not read nor write thumb-printed on the consent form after it was read to them in the presence of an impartial witness. All audios and transcripts were saved in a password protected computer with limited access to the researchers.

Results

Characteristics of health care workers

Fifteen of the 17 health care workers were male with a median age of 38 years old and an interquartile range (IQR) of 32–48 years old. Fourteen were married and 9 were HDAs, 4 were Nurses, 1 was a Medical Assistant, 2 were ARV Coordinators and 1 was an HIV Testing Services Coordinator.

Characteristics of men in the study

The median age of the men was 27 [IQR 21–35]. Most men were married and had attained a secondary school education. More men were self-employed and of the 40 that were HIV infected, 32 were on ARVs (Table 1)

Table 1. Characteristics of men that were involved in the study.

Variable Number Percentage (%) (N = 133)
Age 27 (IQR 21–35)
Marital Status
    • Married 65 48.87
Literacy
    • Able to read 120 90.22
Education Level
    • No education 7 5.26
    • Primary 41 30.83
    • Secondary 69 51.88
    • Tertiary 16 12.03
Employment
    • Not Employed 52 39.10
HIV Testing^
    • Had an HIV Test 101 77.10
    • HIV Infected 40 39.60
    • HIV Uninfected 61 60.40
Uptake of ARVS^
    • On ARVs* 32 80.00

*- The denominator is those that are HIV infected

^- These sections will not add up to N because they are a sub-set from N

Restructuring the delivery of ART services

Participants suggested restructuring the delivery of services in the following areas: Clinic Operations, drug dispensation, and implementation of HIV and AIDS policies. Table 2 below summarizes the key findings. These were proposed to ensure that privacy is maintained to avert undue disclosure of an HIV infected status which may result in being stigmatized.

Table 2. Summary of key findings.

Strategy Areas to restructure Categories
Restructuring of ART service delivery Differentiate clinic operations Clinic days: Dispense ARVs daily
Clinic hours: extension of operational hours
Clinic layout and flow (Male-specific clinics)
Differentiate drug dispensing modalities Offer more drugs
The invention of ARVs with less dosing frequency
Dispense ARVs in the absence of a guardian
Dispense ARVs from the main Pharmacy
Packaging of ARVS
Strengthen implementation of policies Strengthen implementation of test-and-treat Strategy
Reinforce counseling that emphasizes benefits of ARVs

1. Differentiate clinic operations

1.1 Clinic days: Offer ARVs daily. Participants stated that ARVs should be dispensed daily to avoid unintended disclosure of an HIV positive status when they are dispensed on designated days. This was commonly stated among all men and health care workers from rural and semi-urban health centres where ARVs are not dispensed daily. It was stated that on the day when ARVs are dispensed in the rural and semi-urban health centres, all other activities like clinics cease from functioning because the focus for the day is usually on the ART clinic such that community members can easily conclude that all those available at the clinic on such a day are likely to be HIV infected. Participants stated that this attracts undue disclosure of an HIV status which most men feared may result in stigma and discrimination.

“Dispense ARVs daily. This can help people to access ARVs daily because it happens that most of the time people cannot manage to come on Wednesday, just for ARVs ….but the clinic should be open on all days. Younger men FGD Participant at Centre 2

Stigma was a salient factor behind the suggestion to dispense ARVs daily. Men of unknown and known HIV status believed that an important factor for men to initiate on ARVs is having services that are not stigmatizing. They further stated that the current services are prone to stigmatization because of the designation of ART clinic days. Health care workers had similar sentiments of averting stigma and corroborated the men’s suggestion of providing ARVs daily.

“The other thing that increases discrimination is the practice of giving out ARTs on specific days only. So on that particular day, people know that those who are here (health facility) today are here to get ARVs.” HIV Uninfected man, IDI at Centre 3

1.2 Clinic hours: Extension of office hours. Participants suggested that ART Clinics open for longer by opening on the weekends and closing late in the evening during the weekdays. This change if implemented will accommodate the demanding work schedules of men which is a deterrent to ART initiation. ART services are usually offered from morning till 4 pm on weekdays only.

“At least we should have a health worker who will be able to work even at lunch hour so that other people should come at that time to get the drugs … it would have been better for people to be able to get the drugs even during the night may be up to 9 pm. KII, HDA at Centre 6

Upon reflection on their operations and in light of the proposed hours of operation, healthcare workers recommended offering a client the various options of ART initiation available at a facility so that a man makes an informed decision on how and when to access ARVs. Consequently, a man will have a choice to select whether to attend the normal working hours, evening, or weekend services which will promote the initiation of ARVs because a man would select the option most convenient for him.

1.3. Clinic layout and flow. Men of unknown and known HIV statuses complained of the current layout and flow of the clinics where HIV testing and ART occurs. They stated that the rooms for HIV testing in all centres are located in separate locations from where ARVs are dispensed and this compromises their privacy. In a quest to maintain privacy and avoid indirect disclosure of an infected status, men suggested creating a flow that is easy to follow by having HIV testing rooms in the same location as the ARVs initiation section.

They (health care workers) have to change their system and the layout of this hospital in the sections where they conduct HIV testing and provide ART, these sections should be close to each other and the places should also be secure so that these men should be comfortable to come here and access these services”. Younger Men FGD Participant at Centre 5.

Furthermore, men complained of waiting for a long time at the facility before getting all the assistance they need. They recommended a reorganization of the services to hasten a quick exit from the clinic and they believed that this will encourage more men to initiate ARVs.

They must not take long to get the drugs at the hospital because if they take long to get the drugs then one can decide to just go and leave those drugs without accessing them. Man not on ART at Centre 5

As a measure of managing waiting times and safeguarding the privacy of men, both health care workers and men suggested the creation of male-specific clinics that have a designated day and time when services are provided. They asserted that male-specific clinics will promote attendance by men because they will not be mixed with women as it is currently done which is a deterrent for timid men.

“Maybe we should arrange a date or a day for males as we do with women on family planning days or under-five clinics, so that they should come and receive different services such as male circumcision, HIV testing, and AIDS counseling. KII, HDA at Centre 2

2. Differentiated methods of dispensing drugs

2.1 Offer drugs to last for a longer period. Participants suggested that health facilities should dispense drugs that may last for a longer period than the current 1 to 3 months’ supply so that they reduce the number of visits they make to the clinics for refills. The dispensation of drugs that last for a longer period would avert defaulting from treatment that is influenced by the frequency of visits and distance that one has to cover to access health services. Again, men further stated that their decision to initiate on ARVs is at times made after contemplating on the number of visits they have to make cognizant of the appointment schedules that are defined by a health facility.

“Let us say the hospital is far from where you stay and when you go to the hospital they give you medication only for one month, and you should be going there every month, then you get discouraged. You think that all my life like 30 years, so how many trips will I make? They give a few medications but if they can give medication for maybe 5–6 months so that you can rest and go back after sometime.”–Younger Men FGD Participant at Centre 7

2.2 Invention of ARVs with less dosing frequency. Participants suggested the invention of ARVs with less dose frequency because some men delay initiation of ARVs due to the burden of taking them daily. To achieve a reduction in the frequency of taking drugs, health care workers suggested the invention of injectable ARVs that can be administered at spaced-out intervals or tablets that are not taken daily.

“Had it been we can use the injection method it means that the person cannot take much of our time unlike where we are supposed to write everything because the client may take a lot of time. I have to write the next day of the appointment then take the drugs and give it to him unlike when we are supposed to use the injection because we will just give the client the injection and then later just use the registration, then off he goes and it will be a great and simple way”. KII, HCW at Centre 3

“If there was one pill that should take a long time, three months, four months. Not just today, tomorrow, daily. But just to make one pill, when you take it, you should stay for some months. Older men FGD Participant at Centre 4

2.3 Offer drugs in the absence of a guardian. Some participants argued that health facilities should initiate ARVs among men who have shown up without a guardian.

“For the part of taking medicine early, I have seen other people sent back to get a guardian. And if the health workers can stop that and give medication to everyone at the time they come [without a guardian]. Older Men FGD Participant at Centre 7

2.4 Dispense ARVs from the main pharmacy. Participants recommended that ARVs should be dispensed from the main pharmacy of a health facility to minimize stigma. They reiterated that the current practice of dispensing ARVs from a designated room heightens stigma because it indirectly discloses the status of a man who is seen around that room.

“If we can start by giving these drugs through the same way at the pharmacy like what we do with everyone else who has any type of diseaseif we keep on isolating them by telling them to come on their special day to get the ARVS, it will make a lot of people talk about them …” KII, HDA at Centre 3

2.5 Packaging of ARVS. Participants suggested a revision in the packaging of ARVs to avoid unintended disclosure secondary to the conspicuousness of the drug bottles. Unlike other drugs that are dispensed in pill bags, ARVs are packaged in bottles that are difficult to conceal from others thereby disclosing one’s status. Although health workers usually advise clients to purchase a carrier bag after exiting the clinic, men were still worried that unintended exposure would have already occurred at that point. Further to that, men stated that even if the bottles are in a bag, the pills in the bottle rattle, and others can easily notice that one is carrying ARVs and conclude that one is likely HIV infected.

“Even if they say that I should buy the carrier bag or the plastic bag outside, people will be able to recognize them so they have to change and make something special so that people should not be able to recognize that you have carried bottles of ARVs in your hands. Younger Men FGD Participant at Centre 5

3. Strengthen implementation of policies

3.1 Strengthen implementation of test and treat strategy. Health care workers and men reiterated the strengthening of the test-and-treat strategy because it has the potential of ensuring that men initiate ARVs instantly. In other cases, following and HIV infected test result, men are allowed to take time to discuss with their significant others before they initiate ARVs which leads to non-linkage to ART. One health care worker reported as follows:

“During the test-and-treat strategy, we should not wait in initiating a man on ARVS, once the client is found to be positive, immediately he should start the treatment and then being counseled properly right there and not waiting for the guardian to be there”. KII, ART Coordinator

Health care workers noted that when facilities conduct outreach clinics in difficult-to-reach areas, they only conduct HIV tests without initiation of ARVs which is a missed opportunity for men to start on ARVs. As such, they recommended that ART initiation should be part of the services offered during outreach clinics. This will result in more men initiating on ARVs without having to travel a long distance to access ART at a facility.

“It is good to work as a team by coming up with outreach clinics whereby the main focus will be the men but then we will go there with the HDA, the ART provider, and the doctor and then anyone who will be willing to access the HIV testing will be able to access ARVs on the same spot” KII, HDA at Centre 3

3.2 Reinforce counseling that emphasizes the benefits of ARVs. With the advancement in the ART regimes, men and health care workers stated that the benefits of ARVs should be emphasized during counseling sessions to dispel the old belief that equated HIV infection to death. In the past, Malawi experienced many AIDS-related deaths which created fear around HIV and AIDS however, that trend has improved with the invention of better ARVS. Despite that positive trend, participants noted that the messages in the community have not trickled down to all for them to appreciate the relevance of initiating ARVs immediately

“I think we need to be telling them properly about what happens when HIV is in the body, they can understand. If they understand then, they cannot wait to get sick before they start taking medication daily…. they don’t know how the ARVs work in the body. KII, HCW at Centre 4

Men emphasized that counseling and education should be specific to the individual and tailored to address individual issues rather than sharing a general health talk on HIV and AIDS.

“Health workers should explain to every man clearly on his problem; because when a person is dying, he becomes very stubborn and adamant that he does not listen so tell everyone that if you have been found in this status, you are supposed to do ABC. HIV infected man at Centre 4

Discussion

Restructuring of the delivery and conduct of ART clinics is key to optimizing the early initiation of ARVs among heterosexual men in Blantyre. Participants in our study recommended restructuring in the following areas: clinic operations, drug dispensing procedures, and implementation of HIV and AIDS policies. All the concepts on restructuring services centered on reducing stigma and avoiding unintended disclosure that the health system imposes on the men. The maintenance of privacy and non-disclosure of an HIV status is the platform for the suggested ways of restructuring HIV services to promote early initiation of ARVs [47, 48]. Thus, the reduction of stigma is key to engagement with HIV services [49] particularly among men who are the most affected by the denial of an infected HIV status [50]. As a result of stigma, men refrain from engaging with HIV testing, initiating ART and retention in care [51, 52].

The dispensation of ARVs daily without designating a specific day as reported in our study is a measure to avert undue disclosure of an HIV status and courtesy stigma [53]. Stigma has been well documented as the main deterrent to engagement with HIV services at the different cascades [50, 54] and it’s worsened by the location of the HIV/ART clinic [55] and the structural aspects of a vertical clinic [52]. Another disadvantage of offering ARVs on designated days is the promotion of congestion in the clinics that results in an unintended disclosure of one’s HIV status [27]. To mitigate stigma, other countries advocate for pharmacy-only refills which entail dispensing of ARVs to stable clients and it allows for flexibility in accessing drugs [27]. Malawi could model pharmacy-only-refills for stable clients.

Having flexible operating rules of ART clinics is a step towards diffusing the prescriptive nature of clinics which disregards the preferences of the clients thus inhibiting the initiation of ARVs [20]. As alluded to earlier, integration of services would be a step towards the implementation of flexible operating rules. Services could be integrated through the adaptation of differentiated service delivery models [27] which have since been rolled out and are effective in Malawi [28, 56]. Health systems strengthening such as the definition of a stable patient is a prerequisite if a facility has to benefit from implementing the models [28, 56]. As HIV care moves into long term services, integrating them in the health system with other services will promote sustainability and utilization [57, 58]. Successful integration of HIV services in the routine provision of other clinic services will require an assessment of staffing levels [59] cognizant that resource-constrained countries may not be ready for effective integrated services [52].

Furthermore, our findings support service integration by suggesting revisions in the clinic flow which resonates with what was earlier reported in Zambia and South Africa [60]. The study reported that health care workers bemoaned distinct and demarcated areas for HIV services because they promote unintended disclosure and stigma hence affecting engagement with HIV services [60]. Our findings reiterate the results from a review that recommended alteration in the operations of a clinic like improving clinic management and integration of services as a measure to optimize initiation [61]. We argue that One-stop centres for all services are an example of a service integration model that could be rolled out to promote engagement with HIV services among men. One-stop centres curb fragmented services that are conducive for unintended HIV status disclosure [60].

Our study also recommends that health facilities should extend the hours of operation of a clinic to accommodate men that may not be able to report for the services secondary to work or other personal commitments. Our recommendation was earlier suggested in China as a measure of improving linkage to care among men [53, 62]. By extending hours of operation, a centre would be customizing HIV services to the needs of a client [63]. Additionally, this finding builds on a recommendation from earlier studies that reported that HIV-infected participants preferred longer opening hours which will lessen the waiting time at a facility [62, 64]. Currently in Malawi, this measure has only been applied to HIV Testing services, and going forward, it would be important to evaluate this strategy with ART clinics [33].

The creation of male-only-clinics as reported in our study builds on literature that has reported that the creation of male-only-avenues for HIV testing without corresponding ART services on the spot results in the non-initiation of ARVs [65]. Nonetheless, programmatic reports suggest that male-only clinics and extension of hours for them to initiate ARTs were effective in reaching more men with services [65]. Having male-only clinics extends the notion of men supporting each other in peer groups which diffuse masculinity ideologies that affect engagement with HIV services [66]. These male-friendly spaces will also diffuse the notions of viewing oneself as “the real man” resilient to illnesses which inadvertently impedes ART initiation [19]. Programmatic data on the implementation of male-only clinics in Malawi show that they are effective with the potential for scaling [33]. As Malawi advances in the provision of ART services, the incorporation of adherence clubs as ART initiation avenues could be explored [67].

Offering more drugs as suggested in this study is a strategy that was already implemented but requires strengthening to yield more positive outcomes [59, 68]. Previous studies have reported that offering stable client antiretrovirals twice a year is feasible and has resulted in better retention rates with a reduction in viral loads than those clients who were reviewed at the clinic every two months [69]. Furthermore, a Ugandan study reported that six-monthly refills of ARVs for stable clients minimized congestion [27]. Although Malawi implemented Multi-Month Scripting (MMS) for stable clients whereby clients are given ARVs to last them for six months, the effectiveness of these changes is yet to be assessed on a larger scale [56, 70].

Our study further advocates dispensing of ARVs from the main pharmacy and using the same outlet used for dispensing drugs for other illnesses because it will avert undue disclosure of an infected status. Interestingly, a study conducted in South Africa and Zambia showed that the South African participants were content with accessing their ARVs from the main pharmacy while their counterparts were unwilling to access their ARVs from the main pharmacy because they were subjected to long waiting times [60]. Arguably, using one pharmacy for all medications will require improving the number of health personnel and the system to ensure that patients have a quick exit. In Tanzania, patients on ARVs who shared the same waiting area with other patients but accessed their ARVS from a different outlet felt discriminated against and experienced unintended HIV status disclosure [49]. Our findings propose a solution by suggesting that services should not be segregated in the quest to offer quality services because it becomes a deterrent to the initiation and continued use of ARVs. Furthermore, fragmented service and assignment of clinics as per disease condition promotes stigmatization and unintended disclosure which impedes early initiation of ARVs [49]. Another measure to minimize unintended disclosure is through changing the packaging of ARVs to a more concealing one that does not unintendedly reveal one’s status. This finding remains consistent with a Tanzanian study where people living with HIV would discard the ARV packaging to prevent others from noticing that they are on ARVs [49]. This recommendation requires liaising with the funders of the ARVs for consideration.

Our study argues that counseling should emphasize the benefits of initiating ARVs early. This was also raised by a Chinese study whose participants complained of inadequate knowledge of HIV services and care which resulted in non-linkage in HIV care [53]. The information shared should include the preventive benefits that ARVs render, the advantages of the current regimes [71], and should embrace the changing landscape of HIV and AIDS guidelines [20]. Additionally, counseling should be tailored to the specific needs of a particular client and not general education. Previous studies have asserted that there is a need to increase awareness of HIV and AIDS issues among men to improve utilization [72].

The verbatim implementation of the test-and-treat strategy as stated in this study requires a change in the current operations of HIV services where men are tested and are scheduled to initiate ARVs on designated days. This mainly happens because the health personnel that conducts HIV tests are not certified as ART providers. The lack of properly integrated services requires clients to navigate several health care workers and physical areas in a health system which is also a barrier to the initiation of ARVs [73]. Malawi is yet to fully implement a verbatim test-and-treat approach and this is evidenced by the number of people that are not linked to care instantly which necessitates a review of health system operations if we are to eliminate factors that hinder implementation [7476].

Strengths and limitations

Although our study provides greater insights on what men prefer as strategies for initiating ART, caution has to be exercised in implementing our results since the nature of the design does not allow for generalizability. The use of only female data collectors may have limited men from opening up in sharing their views, however, the data collectors were trained on measures of ensuring that men were free to share their insights and also on probing for more information to achieve a comprehensive narrative. Our findings provide strategies that may be rolled out in research to assess various implementation outcomes. The strength of our study lies in the fact that it included men from different geographical areas and, various HIV statuses which broadened the scope of the response. The use of various methods of data collection from different populations is another strength because it provides comprehensive perspectives from varying stakeholders. Future research should focus on implementation strategies of dispensing ARVs daily and integration of the highlighted fragmented services within HIV care.

Conclusion

As HIV and AIDS become a chronic disease, health systems need to be restructured to contain the condition into the routine systems with several pathways of accessing treatment that remain convenient and non-discriminatory to the users. Successful initiation and delivery of ARVs to men will require a revision of the service delivery framework that is currently in use in Malawi. Patient centeredness with a focus on the preference of men in accessing ART services is paramount and requires adapting HIV services to the needs of men in their engagement at every level of service delivery, design, and implementation. Elimination of all kinds of stigma especially those unintentionally imposed by the health system will improve the initiation of ARVs among men.

Acknowledgments

We are grateful to all the study participants that participated in the study, the heads of each facility where we conducted the study and the Director for Health and Social Services for Blantyre in Malawi for institutional support.

Data Availability

Relevant data are within the paper. However full access to the data is restricted to available upon request per ethical guidelines imposed by Malawi's College of Medicine Research and Ethics Committee. Datasets can be made available at reasonable request from the corresponding author in compliance with College of Medicine’s requirements. Interested researchers may also contact The Postgraduate Dean is the Director of Research as well and custodian of College of Medicine's generated data at postgraduate@medcol.mw.

Funding Statement

This study was funded by the Malawi HIV Implementation Research Scientist Training program (Fogarty: D43 TW010060).

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Decision Letter 0

Jeremiah Chikovore

31 Jul 2020

PONE-D-20-08357

“Dispense Antiretrovirals daily!” Restructuring delivery of HIV services to optimize antiretroviral initiation among men in Malawi.

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Academic Editor

PLOS ONE

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The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: N/A

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: No

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: No

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The manuscript addresses the important topic of barriers to ART initiation and adherence among men in Malawi. The manuscript is technically sound, but errors in the English and choppy sentence structure make comprehension difficult at times and interrupt the flow of the manuscript. The manuscript would benefit from heavy editing from a professional editor both in terms of English grammar and organization (flow from one sentence/topic to another; particularly in the introduction and discussion sections).

The methods section is well-developed according to COREQ guidelines.

Information about ethical approval should also be included in the body of the manuscript, in the methods section.

Line 240: Why were all data collectors female? How might that have affected data collection?

In the data analysis section, it would be interesting to provide examples of the thematic codes used.

Lines 489-495: Includes a quote that was included elsewhere.

Lines 508-515: It would be helpful to explain what the role of a guardian is in Malawi.

Given that men of unknown status, HIV-positive men on ARTs and HIV-positive men not on ARTs were sampled, it would be interesting to note whether there were differences in the insights obtained from each category of men.

Given that the study was conducted in 2017, it would be helpful to explicitly discuss how relevant the findings are in 2020. Has Malawi already rolled-out policy changes that address any of the study's recommendations? If so, is there any evidence that those policy changes have improved uptake of timely and continuous ART by men in Malawi?

Regarding data availability, there are many participant quotes in the manuscript, but the authors could also make the de-identified transcripts or excerpts of transcripts reflecting the thematic codes underlying the manuscript available on a public data repository.

Reviewer #2: The paper ‘Dispense Antiretrovirals daily!’ Restructuring delivery of HIV services to optimize ART initiation among men in Malawi is a qualitative study that evaluates the existing health services for men in Blantyre, Malawi. This paper fits into the small but important body of literature from SSA that focuses on HIV service provision for men, a relatively under-researched topic within the HIV literature.

This qualitative paper is containing findings from an extensive study for which the research team interviewed a range of different health workers and male patients recruited from 7 different clinics in the city. I applaud the authors for being able to get so many rich findings, but unfortunately, I have to reject the paper. Below, I will outline the reasons why I made this decision and will give some ideas on how to move forward.

Firstly, the structure of the background and the rest of the paper is not consistent. In the background, a brief overview of the problem at hand is given, but there is little description on how the services are structured within the area, what exact services are offered per clinic and how these clinics work organisationally. This is key for the rest of the paper. Ideas around stigma and other barriers to care for men are mentioned, but not adequately unpacked, even though many of the findings point towards stigmatization of men when they come to the clinic. This is a missed opportunity.

Then, the methods is too long and too descriptive, and could be shorter. However, this can be done through thorough restructuring and proofreading of the paper.

In the results, I wanted to congratulate the authors with being able to recruit 15 male health workers, and I was looking forward to reading their remarks on male patient’s behaviours, but this was not provided in detail. Some of the findings section (1.1) were really long, and the quotes were not explained/contextualised within a structured narrative. Others were really short and provided little detail. There are several mentions of ‘a guardian’, even though I thought only men of 18 and above were recruited, which was confusing. A summary of the findings would have been useful and when reading the different sections, I would provide more details on how you interpreted the findings. I would also restructure the paragraphs and re-analyse part of the data, as some quotes are repetitive. I would definitely include a section on Stigma, and on Health System barriers.

In the discussion, little reference is made to existing strategies for men and little advise if given for implementing changes for future practice.

In summary, I think this paper could improve drastically if the authors worked with an independent writing advisor to restructure this paper, as I think the authors put in an incredible amount of work in getting the data and on this important topic. Overall editing is also encouraged to improve the paper.

**********

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Reviewer #1: No

Reviewer #2: Yes: Myrna van Pinxteren

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

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PLoS One. 2021 Feb 22;16(2):e0247409. doi: 10.1371/journal.pone.0247409.r002

Author response to Decision Letter 0


4 Sep 2020

Dear Editor and Reviewers,

PONE-D-20-08357: “Dispense Antiretrovirals daily!” Restructuring the delivery of HIV services to optimize antiretroviral initiation among men in Malawi.

We are thankful for the review over our manuscript which has not only strengthened the message but also enabled us to reflect on the data we had for a better output. The review was thorough and constructive. Please find below our responses to the queries as raised by the reviewers

Reviewer # 1

1. The manuscript addresses the important topic of barriers to ART initiation and adherence among men in Malawi. The manuscript is technically sound, but errors in the English and choppy sentence structure make comprehension difficult at times and interrupt the flow of the manuscript. The manuscript would benefit from heavy editing from a professional editor both in terms of English grammar and organization (flow from one sentence/topic to another; particularly in the introduction and discussion sections).

Response: The manuscript has been edited for language and we have revised our paragraphs to highlight topic sentences thereby limiting one idea or only related ideas under one paragraph to promote comprehension. This is reflected mainly in the introduction and discussion sections of the manuscript.

2. The methods section is well-developed according to COREQ guidelines.

Response: We appreciate this comment.

3. Information about ethical approval should also be included in the body of the manuscript, in the methods section.

Response: We have included the ethics statement in the main body as reflected in lines 289-309:

Ethical Considerations

Our study obtained ethical approval from Malawi’s College of Medicine Research and Ethics Committee (COMREC- Number P.11/16/2064) prior to study implementation. The District of Health and Social Services (DHSS) for Blantyre and the Director of (Queen Elizabeth Central Hospital (QECH) provided Institutional support for the study to take place in the respective sites. Each study participant provided a written informed consent prior to any study procedures. Participants that could not read nor write thumb-printed on the consent form after it was read to them in the presence of an impartial witness. We assured all participants that their participation in the study would not affect their receipt of medical services at the respective facilities. As a measure of maintaining participants’ confidentiality, anonymity and privacy, we conducted all interviews in a private and quiet room at the facility as per preference of the interviewees. The HIV and ART Coordinators’ interviews were conducted at their office stations as preferred by them. The FGDs were all conducted within a health facility however HIV statuses were not disclosed during the discussion to maintain privacy. The men with an unknown HIV status were referred for HIV testing while those who were HIV infected and not on medications yet were referred for ART as per national guidelines. Interviews with HCWs were conducted after working hours, during lunch breaks and weekends as per participant’s preference to avoid disruption of work. We used codes instead of participants’ names in the study summaries. All audios and transcripts were saved in a password protected computer with limited access to the researchers

4. Line 240: Why were all data collectors female? How might that have affected data collection?

Response: We realise that having only female data collectors may bias our findings, we have acknowledged it as a limitation for the study. This is stated as follows on page:

Lines 802-806: The use of only female data collectors may have limited men from opening up in sharing their views, however, the data collectors were trained on measures of ensuring that men were free to share their insights and also on probing for more information to achieve a comprehensive narrative.

5. In the data analysis section, it would be interesting to provide examples of the thematic codes used.

Response: We have included some examples that led us to realise the thematic codes we presented. See Lines 274-286:

Our three main themes were realised through the collation of similar, related, and recurrent codes, specifically, we grouped all codes on drugs such as dispensation, composition, packaging, and innovations under one overarching theme of differentiating drug dispensing modalities; all codes related to clinic flow, layout and hours and days of operation of a facility were aggregated under Differentiated clinic operations and all codes that referred to the implementation of test and treat and counseling were grouped under the strengthening implementation of available policies theme. We examined each code for further subcategories (40) to ensure that each related concept is grouped under one category and we dropped themes that were not broad enough, for instance, we had a theme on male-specific clinics which we later grouped under clinic operations because it was closely related to that. Fourthly, the research team reviewed the themes and we refined them as appropriate to achieve a correct representation of our findings [

6. Lines 489-495: Includes a quote that was included elsewhere.

Response: We have deleted the repeated quote and have revised that section.

7. Lines 508-515: It would be helpful to explain what the role of a guardian is in Malawi.

Response: We have included information about a guardian and their role in the Malawian setting in the background to our study and it reads as follows:

Lines 112-116: At the point of ART initiation, a client is supposed to nominate a person who is commonly referred to as a “guardian” who is usually a layperson and could be a friend or family member (32). A guardian is counseled along with a client on the HIV status of the client and information on ARVS to promote adherence and at times to collect the ARVs on behalf of the client

8. Given that men of unknown status, HIV-positive men on ARTs and HIV-positive men not on ARTs were sampled, it would be interesting to note whether there were differences in the insights obtained from each category of men.

Response: We reviewed our data set to ensure that we have correctly represented the views and have highlighted in the narratives areas where various men of different HIV statuses shared their views. These are reflected in lines 362, 377, 427 and 472. Our results should also be considered under the context that men with an unknown HIV status were limited in their comments over other parts of ART services as they have not interfaced with them under their status.

9. Given that the study was conducted in 2017, it would be helpful to explicitly discuss how relevant the findings are in 2020. Has Malawi already rolled-out policy changes that address any of the study's recommendations? If so, is there any evidence that those policy changes have improved uptake of timely and continuous ART by men in Malawi?

Response: We have included this information on the changes that have occurred since then and this is reflected as follows:

Lines 116-124: Despite the lag in men accessing HIV services, there have been no specific HIV service programmes rolled out for men in Malawi. However, anecdotal reports show that some health implementing partners piloted male-friendly clinic services in 12 primary health facilities in Blantyre, Malawi in 2018, a year after we had finalized data collection. The male-friendly clinics would open once a week on Saturday’s targeting newly diagnosed men and those that had problems collecting ARVs during the week. Male- friendly clinics were run by both female and male health care workers providing non-communicable health services, sexually transmitted infection services, HIV testing services, and ARVs dispensation.

Lines 716-718: A similar measure of extending hours of operation in HIV services in Malawi was only applied to HIV Testing services and going forward, it would be important to evaluate this strategy with ART clinics.

Lines 700- 703: Nonetheless, programmatic reports suggest that men advocated for male-only clinics and extensions of hours for them to initiate ARTs which has been tested on a small scale in Malawi and may benefit from further research.

Lines 721-724: Programmatic data on the implementation of male-only clinics in Malawi show that they are effective with the potential for scaling (63).

Lines 740-745: Specifically for Malawi, Multi-Month Scripting (MMS) for stable clients was implemented and clients are given ARVs to last them for six months The goal of MMS is to reduce the number of visits to the clinics for refills which also creates a platform for health facilities to focus more on complex clients that need more attention compared to stable ones. The effectiveness of these changes is yet to be assessed on a larger scale in Malawi (51,66).

Lines 788-791: Malawi is yet to fully implement a verbatim of test and treat approach and this is evidenced by the number of people that are not linked to care instantly which necessitates a review of health system operations to eliminate factors that hinder implementation (70–72).

10. Regarding data availability, there are many participant quotes in the manuscript, but the authors could also make the de-identified transcripts or excerpts of transcripts reflecting the thematic codes underlying the manuscript available on a public data repository.

Response: Currently, the data are still being used in manuscript writing by the authors and students within College of Medicine, After all those commitments, the data will be made available in an open domain. However, the data sets can be made available at reasonable requests from the corresponding author in compliance with College of Medicine’s requirements.

Reviewer # 2

1. The paper ‘Dispense Antiretrovirals daily!’ Restructuring delivery of HIV services to optimize ART initiation among men in Malawi is a qualitative study that evaluates the existing health services for men in Blantyre, Malawi. This paper fits into the small but important body of literature from SSA that focuses on HIV service provision for men, a relatively under-researched topic within the HIV literature.

This qualitative paper is containing findings from an extensive study for which the research team interviewed a range of different health workers and male patients recruited from 7 different clinics in the city. I applaud the authors for being able to get so many rich findings, but unfortunately, I have to reject the paper. Below, I will outline the reasons why I made this decision and will give some ideas on how to move forward.

Response: We appreciate your taking the time to review the paper and have found your comments and suggestions valuable.

2. Firstly, the structure of the background and the rest of the paper is not consistent. In the background, a brief overview of the problem at hand is given, but there is a little description of how the services are structured within the area, what exact services are offered per clinic and how these clinics work organisationally. This is key for the rest of the paper.

Response: We have included a section that discusses on how services are provided and organized in Malawi and agree with the reviewer that this component is key to the paper. The following has been included, see Lines 104 to 124

HIV and ART services in Malawi are provided for free in all Government-owned health facilities and at a cost in private and faith-based organisations. The services include HIV testing, ART initiation, and follow-up in care. Health facilities in the urban areas offer HIV services daily while those in semi-urban and rural areas have a designated day within the week when ART clinics run while HIV testing is offered daily. Malawi has integrated the delivery of HIV services with Tuberculosis, Family planning, and Sexual and reproductive health programmes (30). All services are standardized and follow the same monitoring plan regardless of their location and rarely do facilities experience stock-outs of ARVs (31). At the point of ART initiation, a client is supposed to nominate a person who is commonly referred to as a “guardian” who is usually a layperson and could be a friend or family member (32). A guardian is counseled along with a client on the HIV status of the client and information on ARVS to promote adherence and at times to collect the ARVs on behalf of the client. Despite the lag in men accessing HIV services, there have been no specific HIV service programmes rolled out for men in Malawi. However, anecdotal reports show that some health implementing partners piloted male-friendly clinic services in 12 primary health facilities in Blantyre, Malawi in 2018, a year after we had finalized data collection. The male-friendly clinics would open once a week on Saturday’s targeting newly diagnosed men and those that had problems collecting ARVs during the week. Male- friendly clinics were run by both female and male health care workers providing non-communicable health services, sexually transmitted infection services, HIV testing services, and ARVs dispensation.

3. Ideas around stigma and other barriers to care for men are mentioned, but not adequately unpacked, even though many of the findings point towards stigmatization of men when they come to the clinic. This is a missed opportunity.

Response: We have provided more depth in the narratives of our quotes to shed more on stigmatization and the rationale for the suggested strategies. This is reflected in the results and discussion sections on the following lines: 363-368, 375-380, 388-392, 444-447, 472-479, 572-576, 585-592, 668-675, 676-685, 703-708, 746-751, and 756-766.

4. Then, the methods is too long and too descriptive, and could be shorter. However, this can be done through thorough restructuring and proofreading of the paper.

Response: We believe that our methods section is lengthy mainly because we applied the COREQ guidelines to ensure that it retains the quality as needed for a qualitative paper. This paper is also the first one from our project on HIV and men as such we also wanted it to have the methods laid out in detail so that future papers would refer this paper.

5. In the results, I wanted to congratulate the authors with being able to recruit 15 male health workers, and I was looking forward to reading their remarks on male patient’s behaviours, but this was not provided in detail. Some of the findings section (1.1) were really long, and the quotes were not explained/contextualised within a structured narrative. Others were really short and provided little detail. There are several mentions of ‘a guardian’, even though I thought only men of 18 and above were recruited, which was confusing.

Response: We acknowledge that the minimal clarification on a guardian was confusing and we have included a section in the introduction that clarifies who a guardian is to better contextualize our reference on the same. This is reflected as follows:

Lines 112-116: At the point of ART initiation, a client is supposed to nominate a person who is commonly referred to as a “guardian” who is usually a layperson and could be a friend or family member (32). A guardian is counseled along with a client on the HIV status of the client and information on ARVS to promote adherence and at times to collect the ARVs on behalf of the client

6. A summary of the findings would have been useful and when reading the different sections, I would provide more details on how you interpreted the findings. I would also restructure the paragraphs and re-analyse part of the data, as some quotes are repetitive. I would definitely include a section on Stigma, and on Health System barriers.

Response: We have added explanations regarding the suggestions and have alluded to stigma and health system barriers that may have influenced the participants to suggest the stated strategies. We have however not included a section that specifies barriers as that would be outside the objective of this paper.

We have removed repetitive quotes and have grouped similar ideas under one narrative. The aspects of stigma are alluded as in response to Query Number 3, Reviewer 2

7. In the discussion, little reference is made to existing strategies for men and little advise if given for implementing changes for future practice.

Response: We have included the following statements in the introduction and discussion sections to highlight the existing strategies and advice:

Lines 116-124: Despite the lag in men accessing HIV services, there have been no specific HIV service programmes rolled out for men in Malawi. However, anecdotal reports show that some health implementing partners piloted male-friendly clinic services in 12 primary health facilities in Blantyre, Malawi in 2018, a year after we had finalized data collection. The male-friendly clinics would open once a week on Saturday’s targeting newly diagnosed men and those that had problems collecting ARVs during the week. Male- friendly clinics were run by both female and male health care workers providing non-communicable health services, sexually transmitted infection services, HIV testing services, and ARVs dispensation.

Lines 716-718: A similar measure of extending hours of operation in HIV services in Malawi was only applied to HIV Testing services and going forward, it would be important to evaluate this strategy with ART clinics.

Lines 700- 703: Nonetheless, programmatic reports suggest that men advocated for male-only clinics and extensions of hours for them to initiate ARTs which has been tested on a small scale in Malawi and may benefit from further research.

Lines 721-724: Programmatic data on the implementation of male-only clinics in Malawi show that they are effective with the potential for scaling (63).

Lines 740-745: Specifically for Malawi, Multi-Month Scripting (MMS) for stable clients was implemented and clients are given ARVs to last them for six months The goal of MMS is to reduce the number of visits to the clinics for refills which also creates a platform for health facilities to focus more on complex clients that need more attention compared to stable ones. The effectiveness of these changes is yet to be assessed on a larger scale in Malawi (51,66).

Lines 788-791: Malawi is yet to fully implement a verbatim of test and treat approach and this is evidenced by the number of people that are not linked to care instantly which necessitates a review of health system operations to eliminate factors that hinder implementation (70–72).

Lines 716-718: A similar measure of extending hours of operation in HIV services in Malawi was only applied to HIV Testing services and going forward, it would be important to evaluate this strategy with ART clinics.

Lines 700- 703: Nonetheless, programmatic reports suggest that men advocated for male-only clinics and extensions of hours for them to initiate ARTs which has been tested on a small scale in Malawi and may benefit from further research.

Lines 721-724: Programmatic data on the implementation of male-only clinics in Malawi show that they are effective with the potential for scaling (63).

Lines 740-745: Specifically for Malawi, Multi-Month Scripting (MMS) for stable clients was implemented and clients are given ARVs to last them for six months The goal of MMS is to reduce the number of visits to the clinics for refills which also creates a platform for health facilities to focus more on complex clients that need more attention compared to stable ones. The effectiveness of these changes is yet to be assessed on a larger scale in Malawi (51,66).

Lines 788-791: Malawi is yet to fully implement a verbatim of test and treat approach and this is evidenced by the number of people that are not linked to care instantly which necessitates a review of health system operations to eliminate factors that hinder implementation (70–72).

8. In summary, I think this paper could improve drastically if the authors worked with an independent writing advisor to restructure this paper, as I think the authors put in an incredible amount of work in getting the data and on this important topic. Overall editing is also encouraged to improve the paper.

Response: The paper has been revised and edited accordingly

Sincerely,

Alinane Linda Nyondo-Mipando RNM, Ph.D (Corresponding Author)

Attachment

Submitted filename: Letter of Response 2.docx

Decision Letter 1

Jeremiah Chikovore

27 Oct 2020

PONE-D-20-08357R1

“Dispense Antiretrovirals daily!” Restructuring the delivery of HIV services to optimize antiretroviral initiation among men in Malawi.

PLOS ONE

Dear Dr. Nyondo-Mipando,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Dec 11 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Jeremiah Chikovore

Academic Editor

PLOS ONE

Additional Editor Comments (if provided):

Thank you for submitting a revised version of your manuscript. The feedback from reviewers is that, overall the article has improved. However, we cannot accept the article in its current form. Please address all of the reviewers’ concerns fully.

A message that comes through from the reviews is that the article still needs to be edited for flow, grammar, consistency, and redundancies. Whereas one of our reviewers has considered helping with editing, the journal determines rather that this editing be pursued independently by yourselves as authors. Kindy note that PLOS partners with Editage for purposes of editing and would be happy to connect you to this service, while you are also free to use whichever resources you prefer.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: (No Response)

Reviewer #2: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: No

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for the revision. The manuscript is much improved, but it still requires a careful edit to improve the English and the flow, facilitate comprehension and to make it as succinct as possible/eliminate redundancies. With substantial editing, I believe it would be fit to publish as the methodology is solid and the results interesting.

I began making suggested edits, but it became too time consuming to continue in this way:

Lines 89-91: There are two ideas presented in this sentence, but I'm not sure that one follows from the other: The services are also biased towards females (21) such that projects among men have primarily focused on men having sex with men (MSM) (22,23).

Line 115: ARVs instead of ARVS

Line 150: Delete the second "rate": Blantyre district has the highest prevalence rate of HIV among men at 14% as of...

Line 154: IDIs instead of IDIS

Lines 155-157: The following sentence is vague; consider rephrasing or deleting: We deliberately sampled men of varying HIV statuses to gather perceptions of all characteristics of men to ensure wider coverage of our findings.

Line 176: Consider changing "after sharing the study and its eligibility, the facility In-charge" to "after explaining the study and the eligibility criteria, the Officer In-charge assisted with the identification of..."

Lines 186-191: I would rephrase as: "We included heterosexual men (as ascertained by asking them their

sexual orientation) who were 18 years of age and above, able and willing to provide consent, and of a range of HIV statuses: uninfected (confirmed through checking the health passport books), unknown (ascertained by asking if they have ever tested for HIV or not), and HIV infected on ART and not on ART (confirmed through checking the health passport book and/or clinic records)."

Line 191: There are places where you are using "facility In-charge" where I think you may mean "Officer In-charge"?

Line 207: "assistance from HCWs" instead of "assistance for"

Lines 208-211: Split into two sentences: We included men that were 18 years and above, varying HIV status, on ARVs

and not on ARVs, able to provide consent, and willing to participate in the study. These men were identified in the departments within the clinic and the communities around each health facility.

Lines 211-212: I would rephrase as: "Men were scheduled for a discussion at a time and place convenient for them."

Lines 219-220: I would rephrase as: With the exception of VM, all authors conducted interviews and all data collectors were female."

Line 220: I would add: "Before data collection, ALNM, the Principal Investigator (PI) trained..."

Line 221-225: I would rephrase as: "LSK and SS are public health specialists with Masters in Public health. TK has a Bachelor of Nursing and Midwifery and ALNM has a PH.D. in Health Systems and Policy."

Line 230: Replace "shared of her past research" with "shared her past research"

Line 234: add an "s" to question

Lines 235-238: Were these the broad questions for everyone or just for health care workers? Please clarify.

Lines 246-250: This sentence is a bit choppy and unclear.

Line 251: Replace "in a language" with "in the language"

Line 260: NVivo instead of NVIvo

Lines 263-265: Suggest rephrasing as: Codes were generated, deductively, from the objectives of the study and also, inductively, from the data.

Lines 265-267: Suggest editing to: "First, the Principal Investigator listened to the audios and read the transcripts multiple times to gain a deeper understanding of the issues raised"

Table 1: Overall, the table is a bit confusing and needs improvement. I suggest adding a column for percentages as well as for counts. In terms of education level, those who did not have a primary school education had no education? Or more than a primary school education? Perhaps it would be clearer to show each of the different levels of education represented. Uptake of ARVs is only relevant for those who are HIV-positive, not the full sample of 131 participants, so it is difficult to interpret.

Table 2: Make it clear that the table summarizes the key findings.

The discussion section and conclusion require editing and focus to improve comprehension and retention of the key contributions of the manuscript.

Reviewer #2: Comments for the authors:

Thank you so much for giving me the opportunity to review this paper. The structure and writing of this paper has been drastically improved compared to the previous draft. However, I still am of the opinion that the methods section and section 1.1 in the findings is too detailed and can be shortened for readability in the paper. I have also given some suggestions for further readings for the discussion section. Lastly, I would urge the authors to get a professional editor to proofread the publication for grammar, spelling and overall readability of the paper. Please see more detailed comments below. These comments can be addressed with the assistance of the editor.

Introduction:

For the following statements, there is there no reference, not even a webpage, health report or policy brief. ‘The implementation of these services must be based on evidence and this is important for your paper However, anecdotal reports show that some health implementing partners piloted male-friendly clinic services in 12 primary health facilities in Blantyre, Malawi in 2018, a year after we had finalized data collection.’ The implementation of these services must be based on evidence and this is important for your paper.

Methods:

I am still of the opinion that this section is too long and detailed. Although your comment suggest that this is the first publication from the project, it is not a description of the project or M&E paper, therefore there is no need to describe the data collection processes in too much detail. A few more points below which can help you to condense the method section:

a) References on in-depth interviews and other data collection methods are missing (line 131). Identification of participants (both patients and health care workers) for IDI’s and FGD’s could be summarized further. You are loosing the reader here.

b) Data analysis can be further summarized too, the process is interesting, but written to extensively. take out for instance the following sentence: ‘We examined each code for further subcategories (40) to ensure that each related concept is grouped under one category and we dropped themes that were not broad enough, for instance, we had a theme on male-specific clinics which we later grouped under clinic operations because it was closely related to that.’ (line 282 – 284)

Findings:

I still believe that section one of the findings can be shortened, to improve the flow and structure of the article. Paragraph 1.1 contains too many quotes which makes it too repetitive. Pick a few good ones to make your argument and move on to the next paragraph.

Also, be very clear about the description of participants and be consistent. The first quote starting on line 365, states ‘younger men FGD participant at Centre 2’. This sentence is incorrect, unless you are quoting 2 men. I would change it to; ‘Male participant FGD at Centre 2’. This is done throughout the article. Also, is it relevant to know if the participant is infected with HIV or not? And are they honest about it? I would take that out of the descriptions of the quotes as done in line 380.

At line 390 of the findings, again the description of the health care worker is different, here you say ‘KII, HDA at Centre 3’, please be specific or explain the acronyms at the start of the findings. This is about consistency.

In Paragraph 1.2, you want to make a clearer connection between the different paragraphs and signpost the reader. An example from line 450, you can add; ‘in addition to dispensing ARV’s on a daily basis, participants also suggested longer opening times for clinics to accommodate work schedules of men.’ The same goes for other paragraphs in the findings section.

Although this part needs editing and further proofreading, the analysis of the findings and unpacking of the quotes has definitely improved throughout the findings.

Discussion:

Stigmatization and HIV services has been unpacked accurately in the discussion section. There is a missing reference after the sentence in line 722.

The paragraph starting on line 736 gives a good indication of why ARV’s need to be dispensed not per month, but per 3 or 6 months. But there is a need to include that this only works with patients who are stable on ARV’s. In South Africa, stable means being on treatment uninterrupted for at least six months. Another angle to explore can be pill-fatigue, a concept that has come up in similar conversations we had in our research project. Providing treatment for 6 months can prevent pill-fatigue among patients which can lead to non-adherence.

The paragraph starting on line 747 speaks about dispensary of ARV’s in other places than a pharmacy. Here, you can link effectively to studies conducted in South Africa with adherence clubs that meet patients outside of clinic spaces. Medication gets dispensed in community centres or churches, which means patients don’t have to wait in queues, have more freedom and keep their confidentiality. I think referring to some of these studies will improve the discussion section of the paper.

Conclusion:

I would suggest not to start with a statement about HIV stigma and services for men, as this was not the focus of your paper. The focus of your paper is how health services can be better tailored for the needs of men.

**********

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Reviewer #1: No

Reviewer #2: Yes: Myrna van Pinxteren

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PLoS One. 2021 Feb 22;16(2):e0247409. doi: 10.1371/journal.pone.0247409.r004

Author response to Decision Letter 1


2 Dec 2020

Dear Editor and Reviewers,

PONE-D-20-0857R1- “Dispense Antiretrovirals daily!” Restructuring the delivery of HIV services to optimize antiretroviral initiation among men in Malawi.

We sincerely thank you for taking the time to review our revised manuscript. We have addressed the queries raised and find below our responses.

________________________________________

1. Reviewer #1: Thank you for the revision. The manuscript is much improved, but it still requires a careful edit to improve the English and the flow, facilitate comprehension and to make it as succinct as possible/eliminate redundancies. With substantial editing, I believe it would be fit to publish as the methodology is solid and the results interesting.

Response: We have had the article edited for language

2. I began making suggested edits, but it became too time consuming to continue in this way:

Lines 89-91: There are two ideas presented in this sentence, but I'm not sure that one follows from the other: The services are also biased towards females (21) such that projects among men have primarily focused on men having sex with men (MSM) (22,23).

Response: We have revised the sentence and it is in two parts now as follows: The services are also biased towards females (21) which has resulted in limited services for men. The services that are available for men have primarily focused on men having sex with men (MSM) and not the general population of men(22,23). Refer to page 4.

3. Line 115: ARVs instead of ARVS

Response: This has been updated

4. Line 150: Delete the second "rate": Blantyre district has the highest prevalence rate of HIV among men at 14% as of...

Response: The second “rate” has been deleted.

5. Line 154: IDIs instead of IDIS

Response: This has been corrected

6. Lines 155-157: The following sentence is vague; consider rephrasing or deleting: We deliberately sampled men of varying HIV statuses to gather perceptions of all characteristics of men to ensure wider coverage of our findings.

Response: We have deleted the sentence.

7. Line 176: Consider changing "after sharing the study and its eligibility, the facility In-charge" to "after explaining the study and the eligibility criteria, the Officer In-charge assisted with the identification of..."

Response: We have revised the sentence as suggested n line 165

8. Lines 186-191: I would rephrase as: "We included heterosexual men (as ascertained by asking them their

sexual orientation) who were 18 years of age and above, able and willing to provide consent, and of a range of HIV statuses: uninfected (confirmed through checking the health passport books), unknown (ascertained by asking if they have ever tested for HIV or not), and HIV infected on ART and not on ART (confirmed through checking the health passport book and/or clinic records)."

Response: We have revised the sentence as suggested. Refer to lines 175-179.

9. Line 191: There are places where you are using "facility In-charge" where I think you may mean "Officer In-charge"?

Response: We have made this consistent by using one term throughout.

10. Line 207: "assistance from HCWs" instead of "assistance for"

Response: We have changed it as suggested.

11. Lines 208-211: Split into two sentences: We included men that were 18 years and above, varying HIV status, on ARVs and not on ARVs, able to provide consent, and willing to participate in the study. These men were identified in the departments within the clinic and the communities around each health facility.

Response: The sentence has been split into 2 as suggested. Refer to lines 191-193.

12. Lines 211-212: I would rephrase as: "Men were scheduled for a discussion at a time and place convenient for them."

Response: The sentence has been rephrased. Refer to lines 192-193.

13. Lines 219-220: I would rephrase as: With the exception of VM, all authors conducted interviews and all data collectors were female."

Response: This has been updated as suggested. Refer to lines 199-200.

14. Line 220: I would add: "Before data collection, ALNM, the Principal Investigator (PI) trained..."

Response: This has been updated as suggested. Refer to line 200.

15. Line 221-225: I would rephrase as: "LSK and SS are public health specialists with Masters in Public health. TK has a Bachelor of Nursing and Midwifery and ALNM has a PH.D. in Health Systems and Policy."

Response: This has been updated as suggested. Refer to lines 202-204

16. Line 230: Replace "shared of her past research" with "shared her past research"

Response: The word “of” has been deleted.

17. Line 234: add an "s" to question

Response: We have added an “s” to question. Refer to line 213.

18. Lines 235-238: Were these the broad questions for everyone or just for health care workers? Please clarify.

Response: We have added that the broad questions were for both men and health care workers. To ease the understanding, we have added the interview and discussion guides as supplementary files.

19. Lines 246-250: This sentence is a bit choppy and unclear.

Response: We have revised the sentences and have separated all aspects pertaining to quality under one section. Refer to lines 225-239.

20. Line 251: Replace "in a language" with "in the language"

Response: We have revised as suggested. Refer to line 227.

21. Line 260: NVivo instead of NVIvo

Response: This has been corrected. Refer to line 242.

22. Lines 263-265: Suggest rephrasing as: Codes were generated, deductively, from the objectives of the study and also, inductively, from the data.

Response: We have revised as suggested. Refer to lines 245-246.

23. Lines 265-267: Suggest editing to: "First, the Principal Investigator listened to the audios and read the transcripts multiple times to gain a deeper understanding of the issues raised"

Response: We have revised as suggested. Refer to lines 246-248.

24. Table 1: Overall, the table is a bit confusing and needs improvement. I suggest adding a column for percentages as well as for counts. In terms of education level, those who did not have a primary school education had no education? Or more than a primary school education? Perhaps it would be clearer to show each of the different levels of education represented. Uptake of ARVs is only relevant for those who are HIV-positive, not the full sample of 131 participants, so it is difficult to interpret.

Response: We have revised the Table and have presented percentages as suggested although we are aware that is not consistent with reporting of qualitative research results. Refer to page 12.

25. Table 2: Make it clear that the table summarizes the key findings.

Response: This has been updated. Refer to line 304.

26. The discussion section and conclusion require editing and focus to improve comprehension and retention of the key contributions of the manuscript.

Response: We have edited the sections as requested.

¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬-________________________________________________________________________________

Reviewer #2: Comments for the authors:

1. Thank you so much for giving me the opportunity to review this paper. The structure and writing of this paper has been drastically improved compared to the previous draft. However, I still am of the opinion that the methods section and section 1.1 in the findings is too detailed and can be shortened for readability in the paper. I have also given some suggestions for further readings for the discussion section. Lastly, I would urge the authors to get a professional editor to proofread the publication for grammar, spelling and overall readability of the paper. Please see more detailed comments below. These comments can be addressed with the assistance of the editor.

Response: Thank you for reviewing our manuscript once again. We have shortened section 1.1 and have had the manuscript edited for grammar, spelling and overall readability of the paper.

2. Introduction:

For the following statements, there is there no reference, not even a webpage, health report or policy brief. ‘The implementation of these services must be based on evidence and this is important for your paper However, anecdotal reports show that some health implementing partners piloted male-friendly clinic services in 12 primary health facilities in Blantyre, Malawi in 2018, a year after we had finalized data collection.’ The implementation of these services must be based on evidence and this is important for your paper.

Response: We have provided the reference, reference number 33

3. Methods:

I am still of the opinion that this section is too long and detailed. Although your comment suggest that this is the first publication from the project, it is not a description of the project or M&E paper, therefore there is no need to describe the data collection processes in too much detail.

Response: We have shortened the methods section as suggested.

A few more points below which can help you to condense the method section:

4. References on in-depth interviews and other data collection methods are missing (line 131). Identification of participants (both patients and health care workers) for IDI’s and FGD’s could be summarized further. You are loosing the reader here.

Response: We have summarized these further and have provided the omitted references. The references are inserted in line 132.

5. Data analysis can be further summarized too, the process is interesting, but written to extensively. take out for instance the following sentence: ‘We examined each code for further subcategories (40) to ensure that each related concept is grouped under one category and we dropped themes that were not broad enough, for instance, we had a theme on male-specific clinics which we later grouped under clinic operations because it was closely related to that.’ (line 282 – 284)

Response: We have shortened the data analysis section however we have retained some aspects that we were asked to include after the initial review.

6. Findings:

I still believe that section one of the findings can be shortened, to improve the flow and structure of the article. Paragraph 1.1 contains too many quotes which makes it too repetitive. Pick a few good ones to make your argument and move on to the next paragraph.

Response: We have retained those that are quite pertinent to the study.

7. Also, be very clear about the description of participants and be consistent. The first quote starting on line 365, states ‘younger men FGD participant at Centre 2’. This sentence is incorrect, unless you are quoting 2 men. I would change it to; ‘Male participant FGD at Centre 2’. This is done throughout the article.

Response: We have retained Younger Men because our FGDs were divided into older and younger men.

8. Also, is it relevant to know if the participant is infected with HIV or not? And are they honest about it? I would take that out of the descriptions of the quotes as done in line 380.

Response: This kind of identification was brought it after round 1 review. We now need further direction whether this has to be dropped or left as it is.

9. At line 390 of the findings, again the description of the health care worker is different, here you say ‘KII, HDA at Centre 3’, please be specific or explain the acronyms at the start of the findings. This is about consistency.

Response: Please note that all abbreviations have been stated in full at the beginning and we have revised presentation of identifiers to remain consistent.

10. In Paragraph 1.2, you want to make a clearer connection between the different paragraphs and signpost the reader. An example from line 450, you can add; ‘in addition to dispensing ARV’s on a daily basis, participants also suggested longer opening times for clinics to accommodate work schedules of men.’ The same goes for other paragraphs in the findings section.

Although this part needs editing and further proofreading, the analysis of the findings and unpacking of the quotes has definitely improved throughout the findings.

Response: We have had to shorten the quotes used and that part has been take out. We have made connection statements where applicable in the results and discussion section of our manuscript.

11. Discussion:

Stigmatization and HIV services has been unpacked accurately in the discussion section. There is a missing reference after the sentence in line 722.

Response: We appreciate this comment.

12. The paragraph starting on line 736 gives a good indication of why ARV’s need to be dispensed not per month, but per 3 or 6 months. But there is a need to include that this only works with patients who are stable on ARV’s. In South Africa, stable means being on treatment uninterrupted for at least six months. Another angle to explore can be pill-fatigue, a concept that has come up in similar conversations we had in our research project. Providing treatment for 6 months can prevent pill-fatigue among patients which can lead to non-adherence.

Response: This was already presented on line 520. We have taken note of pill – fatigue and this has been recommended as part of future studies, considering that if we start on it in the discussion, we may digress from the core objective of the study.

13. The paragraph starting on line 747 speaks about dispensary of ARV’s in other places than a pharmacy. Here, you can link effectively to studies conducted in South Africa with adherence clubs that meet patients outside of clinic spaces. Medication gets dispensed in community centres or churches, which means patients don’t have to wait in queues, have more freedom and keep their confidentiality. I think referring to some of these studies will improve the discussion section of the paper.

Reference- We have made reference to a review on Adherence clubs. Refer to line 561.

14. Conclusion:

I would suggest not to start with a statement about HIV stigma and services for men, as this was not the focus of your paper. The focus of your paper is how health services can be better tailored for the needs of men.

Response: We have revised the conclusion and it reads as follows (Lines 623-631):

As HIV and AIDS become a chronic disease, health systems need to be restructured to contain the condition into the routine systems with several pathways of accessing treatment that remain convenient and non-discriminatory to the users. Successful initiation and delivery of ARVs to men will require a revision of the service delivery framework that is currently in use in Malawi. Patient centeredness with a focus on the preference of men in accessing ART services is paramount and requires adapting HIV services to the needs of men in their engagement at every level of service delivery, design, and implementation. Elimination of all kinds of stigma especially those unintentionally imposed by the health system will improve the initiation of ARVs among men.

We remain grateful for the constructive review of our manuscript.

Sincerely,

Alinane Linda Nyondo-Mipando, RNM, Ph.D. (Corresponding Author)

Attachment

Submitted filename: Letter of Response.docx

Decision Letter 2

Jeremiah Chikovore

5 Jan 2021

PONE-D-20-08357R2

“Dispense Antiretrovirals daily!” Restructuring the delivery of HIV services to optimize antiretroviral initiation among men in Malawi.

PLOS ONE

Dear Dr. Nyondo-Mipando,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Feb 19 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

Jeremiah Chikovore

Academic Editor

PLOS ONE

Additional Editor Comments (if provided):

Please may you address the following additional queries.

- Line 33-35: Please remove capital letters in the phrases ‘in-depth interviews’, ‘focus group discussions’, ‘health care workers.’

- Line 36: Please remove ‘were’.

- Please check all places where ‘Initiation of antiretroviral drugs’ or similar is mentioned. I would presume it is ‘initiation of antiretroviral treatment’ rather than initiation of drugs.

- Please define ‘ART’, ‘ARVs’ at first use, including in abstract

- Line 39: Please check the sentence in abstract “Restructuring the delivery and conduct of ART clinics”. Do you intend to imply that ART clinics are delivered?

- Line 43-44. Consider restructuring/punctuating the sentence to enhance logic and ideas flow. It is not easy to understand specifically how ‘removing of other structural barrier’ links into the whole sentence.

- Line 45-46: ‘Implementation of test and treat strategy’. I think this phrase could be qualified – is test and treat not being implemented in these facilities/in Malawi?

- Line 39-40. This seems to belong to the conclusion.

- The abbreviation MSM, unless used twice or more, may not need to be included - consider leaving only as ‘men having sex with men’.

- Table 1 revision -please consider moving the absolute number (N=133) from the middle column to percentages column; and have % (N=133); this might read better, if acceptable to the authors.

- Table 1: Please also insert a line in the left column, dividing the age and marital status cells

- Line 771: I suggest writing ‘pharmacy’ in small caps

- Table 1: Please align all numbers appropriately – as is done in the rows for education, and uptake of ARVs, for example

- Table 1. “HIV testing’ is written twice

- Discussion – Please review and consolidate any points likely repeated between para 1 and para 2; I see what appears repeated reference to integration. Kindly check again

- The reference to hegemony masculinities - Please confirm that this is the term intended, and that it is how the cited author names it?

- Table 2: Last line, please remove ‘on’ after ‘emphasizes’

- Table 2: Please remove capital letters where these are not needed in the table text

- Please also remove capital letters where they are not needed in headings and sub-titles

Regarding the following query from the authors, please see Academic Editor’s recommendation.

- Reviewer 2: Also, is it relevant to know if the participant is infected with HIV or not? And are they honest about it? I would take that out of the descriptions of the quotes as done in line 380. Response: This kind of identification was brought it after round 1 review. We now need further direction whether this has to be dropped or left as it is.

- The Academic Editor reviewed the authors’ response in the first revision and understood that the authors felt including HIV status provided context to the quotes. It is suggested that the authors may retain HIV status but indicate (maybe in the methods section) how this status was determined and any possible limitations, e.g. whether they are confident the HIV status report is authentic.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PLoS One. 2021 Feb 22;16(2):e0247409. doi: 10.1371/journal.pone.0247409.r006

Author response to Decision Letter 2


29 Jan 2021

Dear Editor,

PONE-D-20-08357: “Dispense Antiretrovirals daily!” Restructuring the delivery of HIV services to optimize antiretroviral initiation among men in Malawi.

We are thankful for yet another review over our manuscript which has not only strengthened the message and has highlighted the message we aim to communicate to our readers.

Please find below the responses to the queries raised:

1. Line 33-35: Please remove capital letters in the phrases ‘in-depth interviews’, ‘focus group discussions’, ‘health care workers.’

Response: This has been corrected. Refer to lines 33-35.

2. Line 36: Please remove ‘were’.

Response: This sentence has been revised and now reads as follows: We digitally recorded all the data, transcribed verbatim, managed using NVivo, and analysed it thematically. This is reflected in lines 35-37

3.

- Please check all places where ‘Initiation of antiretroviral drugs’ or similar is mentioned. I would presume it is ‘initiation of antiretroviral treatment’ rather than initiation of drugs.

4. Response: Thanks you for this insight, it has been corrected wherever applicable in our manuscript.

5. Please define ‘ART’, ‘ARVs’ at first use, including in abstract

Response: This has been done

6. Line 39: Please check the sentence in abstract “Restructuring the delivery and conduct of ART clinics”. Do you intend to imply that ART clinics are delivered?

Response: Thanks you for this attention to detail as it has clarified the sentence. It now reads as follows in lines 39-40:

Restructuring the delivery of antiretroviral (ARVs) treatment and conduct of ART clinics is key to optimizing early initiation of treatment among heterosexual men in Blantyre

7. Line 43-44. Consider restructuring/punctuating the sentence to enhance logic and ideas flow. It is not easy to understand specifically how ‘removing of other structural barrier’ links into the whole sentence.

Response: We have revised the presentation and it reads as follows in lines 40-47:

The areas requiring restructuring included: Clinic days by offering ARVs daily; Clinic hours to accommodate schedules of men; Clinic layout and flow that preserves privacy and establishment of male-specific clinics; ARV dispensing procedures where clients receive more pills to last them longer than 3 months. Additionally there is need to improve the packaging of ARVs, invent ARVs with less dosing frequency, and dispense ARVs from the main pharmacy. It was further suggested that the test-and-treat strategy be implemented with fidelity and revising the content in counseling sessions with an emphasis on the benefits of ARVs.

8. Line 45-46: ‘Implementation of test and treat strategy’. I think this phrase could be qualified – is test and treat not being implemented in these facilities/in Malawi?

Response: We have clarified the sentence and it now reads as follows:

It was further suggested that the test-and-treat strategy be implemented with fidelity and revising the content in counseling sessions with an emphasis on the benefits of ARVs. Refer to lines 45-47

9. Line 39-40. This seems to belong to the conclusion.

Response: We are proposing to maintain this sentence as it is more of a topic sentence that sets the platform for presenting the results. I tried to remove it and felt that the results section started without a better introduction.

10. The abbreviation MSM, unless used twice or more, may not need to be included - consider leaving only as ‘men having sex with men’.

Response: This has been noted and has been removed.

11. Table 1 revision -please consider moving the absolute number (N=133) from the middle column to percentages column; and have % (N=133); this might read better, if acceptable to the authors.

Response: This has been done.

12. Table 1: Please also insert a line in the left column, dividing the age and marital status cells

Response: This has been done

13. Line 771: I suggest writing ‘pharmacy’ in small caps

Response: This has been done

14. Table 1: Please align all numbers appropriately – as is done in the rows for education, and uptake of ARVs, for example

15. Response: This has been done

16. Table 1. “HIV testing’ is written twice

Response: The repeated words have been deleted

17. Discussion – Please review and consolidate any points likely repeated between para 1 and para 2; I see what appears repeated reference to integration. Kindly check again

Response: This has been reviewed and it was not easy to note the stated repetition, however, we have clarified in an area where we are extending on integration. The revision is as follows in lines 526-527.

As alluded to earlier, integration of services would be a step towards the implementation of flexible operating rules

18. The reference to hegemony masculinities - Please confirm that this is the term intended, and that it is how the cited author names it?

Response: The statement has been revised to avoid misrepresentation on our part and it reads as follows: These male-friendly spaces will also diffuse the notions of viewing oneself as “the real man” resilient to illnesses which inadvertently impedes ART initiation. Refer to lines 560-561.

19. Table 2: Last line, please remove ‘on’ after ‘emphasizes’

Response: This has been done.

20. Table 2: Please remove capital letters where these are not needed in the table text

- Please also remove capital letters where they are not needed in headings and sub-titles

Response: The manuscript has been revised and all unnecessary capitalisations have been revised.

21. Regarding the following query from the authors, please see Academic Editor’s recommendation.

- Reviewer 2: Also, is it relevant to know if the participant is infected with HIV or not? And are they honest about it? I would take that out of the descriptions of the quotes as done in line 380. Response: This kind of identification was brought it after round 1 review. We now need further direction whether this has to be dropped or left as it is.

- The Academic Editor reviewed the authors’ response in the first revision and understood that the authors felt including HIV status provided context to the quotes. It is suggested that the authors may retain HIV status but indicate (maybe in the methods section) how this status was determined and any possible limitations, e.g. whether they are confident the HIV status report is authentic.

Response: We have noted this advice and kindly note that we provided the means of ascertaining HIV status in the methods section.

Sincerely,

Linda A. Nyondo-Mipando RNM, PhD (Corresponding Author)

Attachment

Submitted filename: Letter of Response..docx

Decision Letter 3

Jeremiah Chikovore

8 Feb 2021

“Dispense Antiretrovirals daily!” Restructuring the delivery of HIV services to optimize antiretroviral initiation among men in Malawi.

PONE-D-20-08357R3

Dear Dr. Nyondo-Mipando,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Jeremiah Chikovore

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Acceptance letter

Jeremiah Chikovore

11 Feb 2021

PONE-D-20-08357R3

“Dispense Antiretrovirals daily!” Restructuring the delivery of HIV services to optimize antiretroviral initiation among men in Malawi.

Dear Dr. Nyondo-Mipando:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Jeremiah Chikovore

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    Attachment

    Submitted filename: Letter of Response 2.docx

    Attachment

    Submitted filename: Letter of Response.docx

    Attachment

    Submitted filename: Letter of Response..docx

    Data Availability Statement

    Relevant data are within the paper. However full access to the data is restricted to available upon request per ethical guidelines imposed by Malawi's College of Medicine Research and Ethics Committee. Datasets can be made available at reasonable request from the corresponding author in compliance with College of Medicine’s requirements. Interested researchers may also contact The Postgraduate Dean is the Director of Research as well and custodian of College of Medicine's generated data at postgraduate@medcol.mw.


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