Perspectives Among Health Care Providers and People with HIV on the Implementation of Long-Acting Injectable Cabotegravir/Rilpivirine for Antiretroviral Therapy in Florida

Abstract

Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for antiretroviral therapy (ART) could benefit many people with HIV (PWH). However, its impact will largely be determined by providers’ willingness to prescribe it and PWH’s willingness to take it. This study explores the perceived barriers and facilitators of LAI CAB/RPV implementation among PWH and HIV care providers in Florida, a high prevalence setting. Semi-structured qualitative interviews were conducted in English with 16 PWH (50% non-Hispanic White, 50% cis men, and 94% on oral ART) and 11 providers (27% non-Hispanic Black, 27% Hispanic, 73% cis women, and 64% prescribed LAI CAB/RPV) throughout the state. Recruitment occurred between October 2022 and October 2023 from HIV clinics. Interviews were recorded, professionally transcribed, and then double coded using thematic analysis. The Consolidated Framework for Implementation Research guided the interview guide and coding. While PWH viewed LAI CAB/RPV as effective, predominant barriers included administration via injection, challenges of attending more clinic visits, and a feeling that this made HIV the center of one’s life. Providers additionally expressed concerns about the development of integrase resistance. Barriers noted by PWH and providers outside of the clinic included transportation, stigma, access inequities, and payor issues. Within clinics, providers identified the need for extra staffing and the increased burden on existing staff as barriers. These barriers decreased the perceived need for LAI CAB/RPV among PWH and providers, especially with the high effectiveness of oral ART. Many of the identified barriers occur outside of the clinic and will likely apply to other novel long-acting ART options.

Introduction

In January 2021, the US Food and Drug Administration (FDA) approved the first long-acting injectable (LAI) treatment for HIV, LAI cabotegravir/rilpivirine (CAB/RPV), ushering in a new era in HIV treatment.¹ Historically, people with HIV (PWH) have had to take pills on a daily basis to achieve viral suppression for individual health benefit and to reduce onward transmission.² Despite the advent of single-pill regimens, adherence to daily antiretroviral therapy (ART) is challenging and ultimately may be a barrier to achieving viral suppression.^3,4 Although currently approved for those who are already suppressed, trials are underway to assess the effectiveness of LAI CAB/RPV among those who have not yet achieved viral suppression and who could benefit the most, and small studies have yielded promising results.^5–7

Despite the promise of this medication, implementation of the newly approved LAI CAB/RPV has posed a challenge in many settings, which has prevented many PWH from accessing this medication. In studies of the implementation of other long-acting treatments and those conducted prior to the approval of LAI CAB/RPV, transportation, frequent clinic visits, additional staffing needs, changes to clinic procedures, and regulatory red tape have been cited as barriers.^8–12 Studies conducted in the United States after FDA approval further highlight the increased time needed by personnel to gain insurance approvals and administer LAI CAB/RPV; however, these studies have been limited to a few urban areas.^7,13–15 The potential barriers and solutions to accessing LAI treatment found in the literature occur at a variety of levels, from end-user characteristics and product design to policy-level decisions that could promote or hamper the use of LAI ART.^10,11 Further, these barriers may disproportionately affect those who are most vulnerable and possibly contribute to disparities.¹¹ Therefore, equitable implementation of LAI ART will be of great importance if these medications are to have a substantial impact and be accessible to all who may benefit from them.

The Consolidated Framework for Implementation Research (CFIR) has been used extensively in implementation studies, including a few on LAI CAB/RPV.^11,14,16,17 The model encourages the examination of a wide range of factors that influence the success of an intervention’s implementation, from local economic and infrastructure conditions to the attitudes and beliefs of those implementing or receiving the intervention at the individual level. Therefore, CFIR helps provide a guide for identifying barriers and facilitators to the implementation of an intervention by examining factors outside of the clinic, within the clinic and/or personnel, inherent to the intervention itself, and with the implementation process.

Florida represents a unique setting as a high incidence and prevalence state with seven urban counties selected as priority areas in the Ending the HIV Epidemic (EHE) initiative.^18–20 Moreover, HIV is also of considerable concern outside of these areas, as the rural regions of Florida have disproportionately high burdens of HIV as well.²¹ Some barriers, including transportation and insurance, may be especially salient in Florida owing to the geographic distribution of HIV and state policies. The purpose of the present study is to understand the barriers and facilitators to the implementation of LAI CAB/RPV in Florida using CFIR to inform changes and improvements in LAI CAB/RPV access.

Methods

Study sample & recruitment

Semi-structured, in-depth interviews were conducted with PWH and HIV care providers, with recruitment beginning in October 2022 and ending in October 2023. The PWH were all participants in the Florida Cohort study, which enrolls adult PWH from community-based clinics across the state.^22–24 All English-speaking PWH enrolled in the Florida Cohort who completed the baseline or 12-month follow-up during the recruitment period were invited to complete a semi-structured interview as a part of their Florida Cohort participation. Of those who indicated their interest, the study team attempted to schedule an interview until the goal of interviewing —three to five participants from each active study site (Miami-Dade, Brevard, North Central Florida, Polk County, and Hillsborough) was reached. Providers of HIV care in Florida were eligible if they were comfortable conversing in English and were able to prescribe ART, including advanced practice nurse practitioners (APRN), physicians, and physician assistants. Between two and four providers were recruited from the same clinical recruitment sites used in the Florida Cohort. In Miami-Dade, the Florida Cohort recruited PWH from nonclinical sites, so providers could not be matched with PWH by clinic, so providers were recruited from HIV clinics in the county. Providers were invited to participate through presentations at clinic meetings (n = 2), referrals (n = 1), or direct email to publicly available addresses (n = 8 of 11 contacted). Attempted recruitment via HIV-dedicated Listservs yielded no eligible individuals. For both PWH and providers, we attempted to recruit participants with a wide range of demographic characteristics (e.g., age, race/ethnicity) and participants from both rural and urban areas.

Implementation science frameworks

We used the CFIR to guide the development of interview questions, data analysis, and reporting of findings.^16,25 The interview guide included questions about the relative advantages of LAI CAB/RPV, patient needs and resources, external policies and incentives, tension for change or the need for LAI CAB/RPV, and compatibility with current clinic practices.¹⁶ A draft version of the interview guide was presented both to the Florida Cohort research team, which included HIV care providers and former case managers, and at the UF Qualitative Research Colloquium, a group of experts in qualitative research at the university, to refine the questions before any interviews were conducted. A version of the final interview guide with the questions relevant to LAI CAB/RPV is presented in Table 1.

Table 1.

Interview guide questions

Interviewee	Question
Providers	What has your experience been prescribing long-acting injectable ART (ART given as a shot)?
PWH	What has your experience been with long-acting injectable ART (ART given as a shot)?
Both	What have you heard from others about their experiences?
Both	Comparing long-acting ART to daily pills, what are some advantages of the long-acting ART? What are some disadvantages?
Providers	Imagine your patients or clients were on long-acting ART and needed to come into the clinic every 2 or 3 months for treatments. What would make attending these visits difficult for them? What other factors may prevent them from being able to get these treatments?
PWH	Imagine you were on long-acting ART and needed to come into the clinic every 2 or 3 months for treatments. What would make attending these visits difficult for you? What other factors may prevent you from being able to get these treatments?
Providers	How could your clinic help your patients access these treatments and attend the appointments to receive it? What changes could your clinic make to help your patients with this?
PWH	How could your clinic help you access these treatments and attend the appointments to receive it? What changes could your clinic make to help you with this?
Both	Are there other places where you would want to make these injections available? Where?
Providers	Thinking about outside your clinic, what types of changes could be made in the community or to policy to make it easier for your patients to access these treatments (or get to extra appointments)?
PWH	Thinking about outside your clinic, what types of changes could be made in the community or to policy to make it easier for you to access these treatments (or get to extra appointments)?

Data collection

Each interview lasted between 25 and 65 min. All participants were compensated $50 for their time. Interviews were conducted in-person, on Zoom, or over the phone. The audio for the interviews was recorded. In addition to the audio recordings, providers completed a short demographic survey that also included questions about their time in practice and the number of their patients who have been administered LAI CAB/RPV. For PWH participants, demographic information, including age, race/ethnicity, sex and gender, location, occupation/employment, education level, and current ART regimen were collected as part of the Florida Cohort battery. R.F.H. served as the interviewer and notetaker for all interviews. Transcripts were reviewed by R.F.H. and S.C. to update the interview guide and to provide feedback to the interviewer.

Data analysis

The audio recordings were sent to a HIPAA-compliant transcription service to generate verbatim transcripts. These were then reviewed by the study team to ensure accuracy and remove any identifiable information that remained after deidentification by the company. The audio files were destroyed once the transcripts were confirmed. ATLAS.ti software (Berlin, Germany) was used to organize, manage, and analyze the interview data. The data were analyzed using a codebook thematic analysis approach guided by the CFIR.^26,27 The first step for all coders was familiarizing themselves with the data by reading the transcripts.²⁸ R.F.H. coded the first few interviews to develop the initial codes and codebook, which was then discussed with the study team. R.F.H. then coded the other transcripts as the interviews were transcribed. A second coder (S.R., A.G., and/or H.G.) reviewed the coded transcripts, and points of discrepancy were discussed and resolved. If the two coders could not come to an agreement, S.C. served as a third-party reviewer. Throughout, coders employed open, axial, and selective coding. After coding, themes were identified, reviewed by the coding team, and definitions were developed.²⁸ The team employed peer debriefing, where the codebook was presented at various stages to the UF Qualitative Research Colloquium to get expert feedback on the codes identified by the research team and organization of codes into themes, to ensure our analyses and interpretations were robust.²⁹

Ethics statement

This study was approved by the local institutional review board (IRB#201801680, IRB#202003223). All participants gave informed consent and consented to be recorded prior to beginning the interviews. PWH participants signed an additional consent form for the interview, in addition to the Florida Cohort consent form.

Results

Of the 16 PWH participants, 50% were non-Hispanic White, 50% were cis men, and most (69%) were aged 50 or older. Most (63%) resided in the Central region of Florida. The providers (n = 11) included 10 physicians and 1 nurse practitioner who were mostly cis women (73%) and provided care in the Central region (55%) (Table 2). Only one PWH participant was on LAI CAB/RPV at the time of the interview, although several had discussed the option with their physicians and were considering it. Providers largely considered HIV as their primary area of practice. The majority of providers worked in academic clinics (64%) and had direct experience prescribing LAI CAB/RPV (64%).

Table 2.

Interview Participant Demographics

Characteristic	People with HIV (n = 16)	Providers (n = 11)
Age
18–34	1 (6.3%)	0 (0%)
35–49	4 (25.0%)	6 (54.5%)
50+	11 (68.7%)	4 (36.4%)
Race/Ethnicity
Non-Hispanic White	8 (50.0%)	2 (18.2%)
Non-Hispanic Black	5 (31.3%)	3 (27.3%)
Hispanic	3 (18.7%)	3 (27.3%)
Other/Multiracial	0 (0%)	3 (27.3%)
Gender
Cis man	8 (50.0%)	3 (27.3%)
Cis woman	7 (43.7%)	8 (72.7%)
Transgender or nonbinary	1 (6.3%)	0 (0%)
Florida regionsa
Northern	3 (18.7%)	3 (27.3%)
Central	10 (62.5%)	6 (54.5%)
Southern	3 (18.7%)	2 (18.2%)

^a The regions of Florida can be found here: https://authenticflorida.com/map-of-florida-regions/.

Themes fell within four main domains as defined by the CFIR: intervention, outer setting, inner setting, and individual. The CFIR defines the Outer Setting as the context and environment surrounding the Inner Setting, and the Inner Setting is defined as the location where the intervention is being implemented.¹⁶ Table 3 includes the domains guided by CFIR, themes, and the associated barriers and facilitators and/or potential solutions identified in this study.

Table 3.

Barriers and Facilitators/Potential Solutions

Domain	CFIR constructs (themes)	Subthemes	Barriers	Facilitators/Potential solutions
Intervention Characteristics	Design	Concerns about cabotegravir/rilpivirine resistance and newness	Potential integrase resistance Discomfort with two-drug regimen Unknown long-term effects	Provider education
		Delivery as a refrigerated injection	Injections are unpopular Need for refrigeration	User-friendly packaging and instructions
	Relative advantage	No more daily pills, but more clinic visits	Requires more trips to clinic Feel that HIV becomes the center of their life	Don’t have to worry about daily adherence to oral ART More contact with patients Proposed autoinjectors
Outer Setting	Local conditions	Limited transportation access and timeliness	No access to transportation (private or public) Miscommunications with provided travel Long travel distances and time Hesitancy to use clinic transportation	Taxi/Rideshares provided through clinics or insurance Bus passes
		Inequity in medication access	Concerns about perpetuating inequalities in access and outcomes	Making LAI CAB/RPV available at places closer to where PWH live
	Local attitudes	Stigma and the risk of inadvertent disclosure	Potential for inadvertent disclosure if seen at clinic Counterproductive for normalizing HIV	Avoid inadvertent disclosure from having oral ART around Increased privacy in waiting rooms
	Financing	Issues with insurance	Inconsistent insurance paperwork Prior authorizations Limited to buy and bill options	Case management helping to access social safety nets Better communication with insurance during rollout
		Utility and accessibility of funding from other payors	Difficulty accessing social safety net systems Limited utility of company support for payment	Support from case management to access safety net systems
	Partnerships	Delivery and communication with pharmacies	Pharmacy requires clinic or patient to contact them	Pharmacy provides reminders and regular communication with clinic
		Communication and coordination with other institutions	Limited jail and prison formularies Lack of communications with hospitals and other clinics
Inner Setting	Compatibility	Protocols for injections	Difficulty creating protocols Delays in creating protocols
		Limited clinic hours and long waiting times	Lack of evening and/or weekend hours Inability to get patients in and out of the clinic in a timely manner	Adding additional hours for injections
	Work Infrastructure	Staffing	Limited staff available or trained to administer Limited staff time for follow-up and tracking	Dedicated staff person to schedule and follow-up with injection appointments
Individual	Need	Effective pills and unmet needs	Lack of perceived need owing to effectiveness of current oral treatments Those with greatest need are not eligible	PWH want an option is current ART stops working
	Motivation	Barriers decrease motivation	Lack of motivation due to other barriers	Want to provide PWH with care that fits their lives

Intervention characteristics

Within the intervention domain, the main themes were related to the design of the intervention and the relative advantage of LAI ART over daily pills, and the disadvantages of LAI ART. In addition to these themes, PWH and provider participants acknowledged the effectiveness of LAI ART.

Design: Concerns about CAB/RPV resistance and newness

Some providers expressed concerns over the pharmacokinetic tail of the ART with missed doses, subsequent development of integrase resistance, and loss of effective integrase-based regimens. They also expressed confusion over the selection of rilpivirine as a complement to cabotegravir given the known low barrier to resistance of rilpivirine.

“I would tell you that integrase inhibitor resistance does exist, and there’s going to be people who develop cabotegravir resistance, it’s going to happen. We would have a population of people who possibly would now have viral replication and spreading cabotegravir resistant strains, and we’ve now lost integrase inhibitors entirely. (Provider, non-Hispanic White man, North Florida, has not prescribed LAI CAB/RPV)”

Providers also expressed that it took some time to be comfortable with a two-drug regimen for treating HIV, as opposed to a three-drug regimen, but that increased education for providers helped increase their comfort with a two-drug regimen. PWH concerns centered around the newness of the drug and the unknown long-term side effects of the medication:

“…whenever things appear on the scene very quickly, I like to give it time to do my analysis and see how other people reacted to it, before I just jump into it headfirst. I don’t wanna be a deer in headlights, you know? (PWH, non-Hispanic Black man, Central Florida, on oral ART)”

Design: Delivery as a refrigerated injection

The medication being delivered as an injection was polarizing and some participants mentioned the discomfort of injecting CAB/RPV or receiving other types of injections. While some PWH reported that they had no issues with shots, some immediately rejected the drug owing to it being a shot. One participant simply said:

“They are injections, and I don’t like that. (PWH, non-Hispanic Black woman, Central Florida, on oral ART)”

In addition to the general dislike of shots, providers noted that the need for the medication to be refrigerated also limited their ability to give the medication at times.

Relative advantage: No more daily pills, but more clinic visits

Some participants perceived LAI ART as an opportunity to worry less about taking their ART pills on a daily basis, lessening their mental burden by reducing reminders of their HIV status and the security in knowing they were covered for the next two months:

“It’s just a lot easier and a lot better. You don’t have to worry about anything because once you get injected, it’s in your system. Instead of worrying about taking pills every day, and if you miss a day, then your T cells go down, but with this, it stays normal. You don’t have worry about anything, and your T cells go up… (PWH, Hispanic man, Central Florida, on LAI CAB/RPV)”

However, some felt that having to come into clinic every month or two would entail a lot more effort on their part.

“What would make it [going to injection appointments] difficult is the fact that now you have made the center of my life my disease. I refuse to do that. (PWH, non-Hispanic Black man, Central Florida, on oral ART)”

Providers acknowledged that increased clinic visits could be hard on many of their patients but saw the additional contact as a positive. Participants suggested that an option that allows for self-injection or autoinjectors could remove the need for a clinic visit.

Outer setting

Within the outer setting, we identified four themes within the CFIR (local conditions, local attitudes, financing, and partnerships & connections). The CFIR defines local conditions as the economic milieu and physical and financial infrastructure around the clinic (“inner setting”). Local attitudes are the values and beliefs within the broader community that influence the implementation on an intervention.

Local conditions: Limited transportation access and timeliness

Transportation was commonly cited as a barrier by both patients and providers, including long travel times and inability to access transportation. For those with personal vehicles, participants noted the additional costs of gas and parking fees as barriers. Access to public transportation was nonexistent or slow. One participant recounted the various transportation options available to them along with the negative aspects of those options:

“Sometimes I don’t have a car. I catch a bus. From where I’m at, catching the bus is very tedious because the bus only comes so far at a certain time at the end of the day, which is very early—about 4:00. I try to make my appointments in the morning. If I’m not catching the bus, then I’ll drive. If I don’t drive, I catch the Lyft. (PWH, non-Hispanic Black man, Central Florida, on oral ART)”

PWH also recounted times when transportation support services, either offered by the clinic or through insurance, worked well and times when they had great difficulty using these services.

“The transportation that <Insurance> has is jacked. I missed an appointment yesterday because the Uber that picked me up had another passenger. Well, she had to drop him off first. Then <Insurance> got it mixed up. They had the lady come to pick me up at 9:57. My appointment was at 10:00. I missed that appointment. (PWH, Non-Hispanic Black woman, South Florida, on oral ART)”

PWH also indicated hesitancy to use some transportation services provided by their clinics owing to privacy concerns and not wanting to be a burden.

Local conditions: Inequity in medication access

Several participants expressed concerns about how structural barriers, including the transportation barriers mentioned above and financial barriers, can cause inequitable access to LAI CAB/RPV and questioned whether investments should be made for treatment that is not equitably provided.

“Considerations about equity are top of mind for me when we’re talking about new agents [LAI CAB/RPV]. If it’s not gonna be available to a broader portion of the population, then I don’t think it’s the direction we should be moving in. (PWH, non-Hispanic White man, North Florida, on oral ART)”

Provider and PWH participants suggested that having LAI CAB/RPV available at local pharmacies, through primary care providers’ offices, and/or through mobile health units could increase access to these medications. However, they noted that these solutions were not without their own barriers to implementation.

Local attitudes: Stigma and the risks of inadvertent disclosure

Several providers and PWH mentioned that an advantage of LAI ART is that it removes the possibility of inadvertent status disclosure from someone finding their ART or having to take ART in public. However, participants worried that having to go to the clinic more would increase the risk of someone seeing them and inferring their status. These concerns resulted in more hesitancy toward LAI CAB/RPV. To help address these concerns, PWH recommended that clinics do more to protect privacy including increasing privacy in waiting areas and decreasing time spent in waiting rooms.

“The way how the waiting room is set up, they may want to look at that in the future to give them a safe space. When I come here I want to be in a little area where I can really be by myself, as opposed to being out in the open. (PWH, non-Hispanic Black man, Central Florida)”

Financing: Issues with insurance

Another commonly cited barrier was the process of getting the medication approved through insurance. Large amounts of paperwork, unmanageable billing practices, and long wait times were mentioned. One provider recounted issues they had with the insurance-related paperwork:

“Preauthorization. We order the medication. We send all the paperwork. They send it back to us and say it’s not complete. They don’t say what part is not complete. We look at the document. The document is complete. We redo the document again and we send it back. Okay, now it’s complete. (Provider, Hispanic woman, Central Florida, has prescribed LAI CAB/RPV)”

Other providers expressed frustration that they were told to prescribe the first dose while waiting for a prior authorization to be approved. Whereas others were consistently recommended to do a buy-and-bill (i.e., the clinic pays for the drug and then requests reimbursement from the appropriate payor after the drug has already been administered) when this was not financially feasible. Participants also recounted times when their ability to access medications was interrupted by insurance changes or had to change insurance to access LAI CAB/RPV.

“The type of insurance that I have through the marketplace right now–it’s not good. [My doctor] told me when open enrollment comes back around to go through more some of the bigger name insurance companies. They seem to have luck with those with other clients. (PWH, non-Hispanic Black woman, Central Florida, on oral ART)”

Financing: Utility and accessibility of funding from other payors

Other programs to support the financing of HIV care and treatments appeared to have their own sets of issues. For example, one participant described the Ryan White eligibility process as follows:

“…Enrolling in public HIV care programs is somewhere between getting a mortgage, which is probably the most difficult paperwork verification process I’ve ever been through in my life, and annual taxes. It’s somewhere in between those two as far as a burden is concerned. (PWH, non-Hispanic White man, North Florida, on oral ART)”

Although, other participants reported that the process was smooth and that most of the workload fell onto their case manager and not them directly. Participants also mentioned that the financial assistance offered by the manufacturer was not as simple as they thought and determined that the solutions (i.e., buy and bill) offered by the company would not work for their clinic.

“Then <Company> that was marketing this, had this system where they said that they had resources that could help determine the financial issues around these [LAI CAB/RPV], and we used them multiple times, and they were not helpful. We ended up just not using them anymore. (Provider, non-Hispanic White woman, North Florida, has prescribed LAI CAB/RPV)”

Partnerships & connections: Delivery and communication with pharmacies

External pharmacies that offered increased support and better communication greatly facilitated the ordering and delivery process for clinics, while the lack of communication acted as a barrier. Participants recounted several difficulties with having the LAI ART delivered in a timely manner and experienced varying levels of support from community pharmacies regarding coordinating, ordering, and delivering LAI CAB/RPV to clinics.

“<Pharmacy 1> always called ahead of time to ensure we're ready for the delivery. We know when to look out for the package. <Pharmacy 2> does not do that, and the patient has to be very proactive. They don’t do auto refills. They don’t facilitate the patient getting the medication other than when it’s asked [for] or they provide it. Whereas <pharmacy 1> says, ‘Okay. The patient’s due. When do you wanna have it delivered?’ That presents a challenge, and we’ve had the medication delivered to the <clinic complex> and not had it appropriately handled. (Provider, non-Hispanic White woman, North Florida, has prescribed LAI CAB/RPV)”

Partnerships & connections: Communication and coordination with other institutions

Provider participants mentioned concerns about providing LAI CAB/RPV to patients who become incarcerated, those who may experience hospitalization during periods when another injection is needed, or those who switched HIV clinics. They were unsure of how the communication process with the institutionalized settings would work.

“If I say, ‘Hey, I have this guy’s on <LAI CAB/RPV>.’ They’ll just say, ‘Oh, we don’t have that here. We have Nevirapine.’ You’re like, ‘first of all, that’s not his genotype.’ They’re not very sympathetic, at least for the jail side. (Provider, non-Hispanic Black woman, Central Florida, has prescribed LAI CAB/RPV)”

Inner setting

Within the inner setting, we identified compatibility, available resources, and work infrastructure themes from the CFIR. Compatibility, according to the CFIR, is the degree to which the intervention fits within existing processes. Available resources include the materials needed for an intervention and the physical space to implement the intervention. Work infrastructure is how well the intervention is supported by staffing levels and how tasks are organized within clinic staff.

Compatibility: Protocols for injections

Providers mentioned challenges in developing protocols for their clinics to deliver medications and the importance of having a protocol in place. Issues with developing a protocol included having to change the clinic flow to accommodate LAI ART, approval processes from their health systems and insurance companies, handling increased scheduling demand, and enacting follow-up policies for missed visits. For example, one provider noted:

“…our clinics are not structured for very rigid clinic appointments. As such, our usage of LAI CAB/RPV has been much less than it should be. (Provider, non-Hispanic Asian man, South Florida, has prescribed LAI CAB/RPV)”

Compatibility: Limited clinic hours and long waiting times

Several participants, both providers and PWH, mentioned increasing the flexibility of clinic hours to better match the schedules of patients who work during standard business hours and are not able to take time off work on a monthly or bimonthly basis.

“It’s just a matter of the timing. Is it gonna be only available Monday through Friday? Some people work. Most health facilities close at 4:00. It would have to be accessible—even a little bit later in the evening, 6:00, 7:00. Maybe available on weekends for a short period of time. (PWH, non-Hispanic Black man, Central Florida, on oral ART)”

Both provider and PWH participants mentioned the importance of getting patients in and out quickly for the injection appointments, and several worried that it would not be possible with their current clinic schedule.

“…I would love to see us have some kind of mechanism that they don’t have to take time off work, and I would like to say they come in and they’re right out in 15 minutes. That's not how it happens… (Provider, non-Hispanic White woman, North Florida, has prescribed LAI CAB/RPV)”

Work infrastructure: Staffing

Providers mentioned the importance of having a designated staff member in charge of coordinating injection appointments and following up with patients who need to come into the clinic. Providers at clinics that did not have staff to fill this role mentioned that most of the work to schedule and follow-up on these visits fell to the providers, who already have limited time. Clinics with designated staff for injections noted that they would need to have more staff involved in the process if the demand increased. In clinics with enough staff, providers discussed challenges with training all the staff in the new protocols:

“The training aspect [is a challenge]. It’s good and bad things when you’re such a large health system. It’s not I have one nurse to train. We have 20 some odd nurses that need to be trained… (Provider, Hispanic woman, Central Florida, has prescribed LAI CAB/RPV)”

Individual

Within the individual domain, themes around need and motivation were identified among interviewees.

Need: Effective pills and unmet needs

All the PWH participants mentioned that engaging with their HIV care and taking their ART as prescribed were very important to them, and many participants acknowledged that LAI ART could be a wonderful option for some PWH. Despite this, many PWH did not personally feel the need to switch their regimens:

“Why switch what’s doing well for me right now? For 20 years, I’ve been undetectable, and nothing has changed. (PWH, non-Hispanic White man, Central Florida, on oral ART)”

PWH did mention that if their daily oral ART stopped working then having other options, even if those options went outside of their comfort zone, would be something that they wanted available to them. Providers also felt that this was the prevailing view of the PWH in their care. Providers also mentioned that many PWH who need an alternative to daily pills can’t access LAI CAB/RPV; they are either ineligible for LAI CAB/RPV since they are not virally suppressed, or the bimonthly injection schedule is too frequent for them.

“We come up with multiple patients who have jobs that take them out of state a lot. They really wanted to do it, because getting their meds every month is a challenge if they’re out of state. Then, they realize they can't reliably be here every eight weeks, so that's been a challenge too. (Provider, non-Hispanic Black woman, Central Florida, has prescribed LAI CAB/RPV)”

Motivation: Barriers decrease motivation

While some providers expressed excitement for this option, other providers mentioned that the barriers presented by the insurance-related paperwork and extra work on providers was a disincentive for prescribing LAI CAB/RPV. Ultimately, this hesitancy to provide the medication could be overcome if the patient wanted LAI CAB/RPV and was eligible.

“There’s definitely no incentive from a physician’s standpoint to start this medication because—unless the fact that I wanna help my patient if they want to try this [LAI CAB/RPV]. (Provider, non-Hispanic Asian woman, North Florida, has not prescribed LAI CAB/RPV)”

Discussion

PWH and HIV care providers in Florida were invited to participate in qualitative interviews that asked about their experiences with and perceptions of LAI CAB/RPV to understand barriers to implementation and uptake with to the goal of identifying potential solutions. These responses were examined within the context of the CFIR model, which contextualize barriers to wider implementation of LAI CAB/RPV in the outer/community setting and inner/clinical setting, individual attitudes, and as a part of the product itself.

In the outer context, transportation access and infrastructure were key barriers. Because of the lack of efficient and accessible public transportation within Florida, clinic- or insurance-provided transportation services are necessary, although not without their own shortcomings.^30–32 Transportation challenges are present throughout the United States.^11,13,33 In the short term, increased funding for clinic-provided transportation could help reduce this barrier. The investments needed to address the transportation barriers, including improvements to public transportation, would likely be large and take many years to implement. Future long-acting ART development could focus on longer lasting options with decreased frequency of administration to reduce the number of clinic visits, or on self-administration to avoid transportation-related barriers.

Expanding administration options to allow for pharmacists to provide LAI CAB/RPV could help improve access, including in rural areas. Pharmacies may be more accessible to rural populations with few HIV care options nearby.^34–38 However, administration at a pharmacy may be hampered by permanent closures of pharmacies, restrictions on which pharmacies can order the drug, and issues with billing for the administration event.^39,40 Changing restrictions on who can order LAI CAB/RPV could also improve access in rural areas, as could increase funding for rural HIV care to incentivize providers to work in these areas. Alternatively, offering home administration could be an acceptable method to reduce the travel burden on PWH, although it would move this burden to clinics or pharmacies.⁴¹

Financing was another key barrier noted in the outer setting. The extra burdens of navigating payment and payor approval were often experienced by the providers and became a disincentive for providing this medication. Hiring additional staff to help navigate and track prior authorization requests, as well as reimbursements and payments for the medications, can cause clinics to incur additional costs.¹³ Although, this could help reduce the burden on providers throughout the insurance approval process.^13,14 Despite initial hopes that determinations from the Centers for Medicare and Medicaid Services would provide the blueprint for the insurance market, the high variability in how LAI CAB/RPV can be handled even within these programs makes this unlikely.^42,43 Finally, the process for PWH accessing Medicaid and the AIDS Drug Assistance Program could be streamlined and the eligibility criteria relaxed to make it easier to receive LAI CAB/RPV through these programs.^44,45

In the inner context, participants noted that clinics needed additional personnel, space, and time to implement LAI CAB/RPV more effectively.^11,13,46 The need for additional personnel stems partially from having to deal with a complex insurance landscape and also an increase in patient engagement owing to greater numbers of visits. As in other studies, implementation of LAI CAB/RPV seemed to be smoother when clinics were able to task a single person or small group of people with managing LAI CAB/RPV approvals and administration.^11,13 Although this increases the implementation of LAI CAB/RPV, it places additional costs on the clinic and may add additional responsibilities to existing staff.^11,13 Additional funding support from the state and federal government through existing HIV programs could help support the additional personnel needed to coordinate insurance approvals and injection appointments.

HIV-related stigma continues to play a large and important role, as many participants were concerned about inadvertent HIV disclosure. Others have noted that LAI CAB/RPV could help reduce the threat of inadvertent disclosure, but few have noted that going to a clinic that is HIV- or sexually transmitted infection-specific could also carry a risk of involuntary disclosure.^9,11,12,47 Some of the potential solutions to the travel barriers (i.e., home- or pharmacy-based administration) may also be hampered by stigma owing to the increased risk of inadvertent disclosure.^41,48 Clinics should work with their clients to build confidence, reassuring that their privacy will be protected, and seek advice on changes that could make waiting areas feel safer. In addition, clinics could explore LAI CAB/RPV as an option for clients who feel the need to engage in pill hiding behavior. However, these changes do not address the larger issue of stigma within the community. Widescale community education about HIV is necessary to address the negative public attitudes that drive these concerns.⁴⁹

While participants acknowledged that some PWH may want or need an option like this, LAI CAB/RPV was of limited interest to them. Here and in other studies, many PWH were comfortable with their current ART regimens.^47,50 In addition, while many PWH saw LAI CAB/RPV as freeing, the increased appointments are seen as limiting by others, which is also reflected in quantitative studies.⁵¹ This lack of perceived need could also reduce the uptake of other long-acting ART options. The more concerning situation was among those who felt that they needed an alternative but could not get it. Some preliminary studies have indicated that the prescribing guidelines could be loosened to help those who have trouble adhering to oral ART.^6,7 However, many factors contribute to poor adherence and poor care engagement, so they often occur together.^24,52–54 Therefore, there is still a need for new long-acting ART options to help reach these populations, and these options should be developed with the needs and preferences of these PWH in mind.

This study has some limitations. First of all, PWH enrolled in the study, only one had direct experience with LAI CAB/RPV, although many participants were aware of the option and had seriously considered it. Of over 800 participants in the Florida Cohort, only 12 ever reported being on LAI CAB/RPV, so this reflects the low uptake in the parent study. Likewise, most providers had some experience prescribing and administering LAI CAB/RPV, so the views of those who may be against LAI CAB/RPV are underrepresented. Second, most participants came from outside of South Florida, where HIV prevalence is highest. However, HIV outside of South Florida is often overlooked, so these results do provide valuable information on other regions. Third, the interviews were only conducted in English, so the experiences of those who were not comfortable conversing in English were not captured. Very few Florida Cohort participants were Spanish monolingual speakers (3%), so this population was likely underrepresented in the parent study. These individuals may face additional barriers to accessing LAI CAB/RPV, and future studies could focus on the experiences of Spanish- and Haitian Creole-speaking PWH. Fourth, non-Hispanic Black and Hispanic PWH were underrepresented here compared to the population of PWH in Florida (43% non-Hispanic Black and 27% Hispanic).⁵⁵ Similar to Spanish-speaking PWH, PWH within these groups may encounter additional barriers.

In conclusion, most of the barriers identified occurred within the outer setting, including in accessing and paying for the medication, and several barriers were related to the medication’s delivery as an injection and the limited eligibility criteria. These resulted in a lack of perceived need and disincentives to provide the medication. Changes within the outer setting, largely requiring policy changes and increased funding, are needed to reduce transportation barriers, work burden owing to insurance approvals, fund more personnel and supportive services within clinics, and reduce community stigma. Further, the barriers to making LAI CAB/RPV more widely available are likely to be encountered in the implementation of other long-acting ART options that are being developed.

Authors’ Contributions

R.F.H., R.L.C., S.C., and P.M.: Conceptualization; R.F.H., P.M., M.W.: Investigation; R.F.H., S.S.R., A.G., H.G., S.C.: Methodology & Formal Analysis; R.F.H.: Writing—Original Draft; R.F.H., S.S.R., A.G., H.G., P.M., M.W., R.F.L., R.L.C., S.C.: Writing—Review & Editing; S.C: Supervision.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

This work was supported by the National Institute on Alcohol Abuse and Alcoholism (grants F31AA030518, U24AA022002) and the National Institute on Drug Abuse (grant K01DA057881-02).