Evaluating HIV testing preferences and uptake of oral fluid-based HIV self-testing among men who have sex with men and transgender women in the Greater Manila Area of the Philippines: an explanatory sequential mixed-methods research protocol

Abstract

Introduction

Rapid antibody testing is a cornerstone in HIV case finding and management. Without tools for rapid detection and diagnosis of HIV infection, none of the downstream targets for linkage to antiretroviral therapy and viral suppression in the HIV treatment cascade could be achieved. In the Philippines, oral HIV self-testing (HIVST) has not been adapted for use. Moreover, no study has been conducted to determine HIV testing preferences and acceptability of oral HIVST among Filipino men who have sex with men (MSM) and transgender women (TGW). The protocol describes a mixed-method approach to evaluate HIV testing preferences and acceptability of oral HIVST vs currently available testing modalities among MSM and TGW in the Greater Manila Area and determine the factors underlying the participants’ selection of a testing modality.

Methods and analysis

This study will use an explanatory sequential mixed-methods design. The initial phase will involve a cross-sectional survey with a pre/post questionnaire format design targeting 480 MSM and 478 TGW. A case study phase follows, with 80 in-depth interviews to provide more detailed qualitative insights. Quantitative data will be analysed using multinomial logistic regression models, while qualitative data will be examined using an inductive approach through thematic analysis. A narrative approach will synthesise the quantitative and qualitative findings for a unified interpretation and comprehensive understanding of the results.

Ethics and dissemination

This protocol has been approved by the University of the Philippines Manila Research Ethics Board (UPMREB 2023-0579-01). The study findings will be disseminated through peer-reviewed journal publications and academic presentations at conferences.

STRENGTHS AND LIMITATIONS OF THE STUDY.

• The protocol will employ an explanatory sequential mixed-method design, allowing for a comprehensive understanding of quantitative and qualitative data.

• The design supports the exploration of participants’ actual insights regarding their preferred HIV testing modality by assessing their choice of test, the acceptability of their selected testing method and the contextual factors that influence their decisions.

• The recruitment methods include both online and offline strategies, reaching key populations (men who have sex with men (MSM) and transgender women (TGW)) through multiple channels such as social media and physical hotspots.

• The study focuses only on participants from the Greater Manila Area, potentially limiting the generalisability of the findings to other regions of the Philippines, especially those with lower internet penetration, which may introduce selection bias.

• While the study focuses on MSM and TGW, other key populations at risk for HIV, such as sex workers or people who inject drugs, are excluded.

Introduction

From 2012 to 2023, the Philippines was recorded to have one of the fastest-growing HIV epidemics in the Asia Pacific Region, with a 411% increase in daily incidence.¹ Closing the remaining gap in HIV diagnosis requires differentiation of testing options to help key populations (KPs), including men who have sex with men (MSM) and transgender women (TGW), overcome obstacles in HIV prevention, diagnosis, treatment and adherence services.^{2 3}

HIV testing in the Philippines

The HIV epidemic in the Philippines is considered a concentrated epidemic—that is, one observed to spread among one or more subpopulations rapidly but not well-established in the general population. For this reason, HIV testing in the country focuses mainly on KPs, including MSM and TGW, which as of 2024 comprises over 88% of diagnosed cases. To improve access, the Philippines replaced Republic Act (RA) 8504, which institutionalised HIV education, guidelines for HIV testing and safeguards against discrimination, with RA 11166, which expanded provisions o²n HIV testing, such as community-based screening, and allowed for the testing of 15 to 17-year-olds without parental consent.^{4 5}

Estimates suggest that the Philippines is expected to have at least 215 400 people living with HIV (PLHIV) in 2024, but only 135 056, or 63%, have been tested and confirmed as of December 2024.⁶ During the same period, 88% of diagnosed male cases, totalling 118 709, were acquired through sexual contact with other males, including transgender individuals assigned male at birth. This highlights a significant testing gap between the estimated number of PLHIV and the actual number of people who have been tested. Addressing this disparity is crucial, as it leaves a large, vulnerable population with undiagnosed HIV infections that require targeted screening interventions. While KP-focused community-based organisations (CBOs) have significantly expanded access to HIV services in the Philippines, and HIV testing is offered free of charge at most health facilities that provide HIV-related services in the country, the current testing modalities appear insufficient to reach those who remain untested.⁷,¹⁰

To help reduce this burden, the Philippines’ Department of Health included HIV self-testing in its 2022 Guidelines for Implementing Differentiated HIV Testing Services.^{3 7} However, current HIV testing in the country uses blood-based rapid antibody tests and self-tests (Chembio SURE CHECK). The SURE CHECK test kit has a 99.4% sensitivity and 100% specificity, offers results in as fast as 15 min but requires a blood sample from a finger stick. Despite its widespread use, challenges remain with blood-based HIV testing modalities, including client aversion to blood drawing and needles. To address these concerns, the Philippines may consider adopting blood and oral fluid-based tests as part of its advanced HIV testing strategy.¹¹,¹³

Oral HIV testing modality and its acceptability

For many years, studies have evaluated the acceptability of both oral fluid-based and blood-based HIV self-testing (HIVST) worldwide. HIVST consistently boasts high acceptability in the literature.¹⁴,¹⁹ In particular, regarding oral fluid compared with blood-based HIV self-testing, several studies have indicated a consistent overall preference for oral testing over blood testing for HIVST.^{11 20 21} Oral fluid-based testing for HIV using the OraQuick test kit demonstrated 99.6% (95% CI = 98.5% to 99.9%) sensitivity and approximately 100% specificity (95% CI=99.7% to 100%), making it the first oral antibody test approved for use by the US Food and Drug Administration in 2004.²² However, despite the demonstrated utility of oral antibody tests for HIV and their deployment in national HIV strategies worldwide, there remains limited evidence regarding the acceptability of oral antibody HIV testing in the Philippine setting, especially among KPs.²³,²⁸

Background of the study

Given the demonstrated sensitivity and specificity of oral-based antibody tests through OraQuick, the lack of this testing modality in the Philippines and the absence of data on the HIV testing preferences of KPs in the Philippines, our study aims to assess the HIV testing preferences and the acceptability of the oral-based OraQuick rapid antibody HIVST among MSM and TGW in the Greater Manila Area (GMA) Philippines. There is an excellent opportunity to introduce oral fluid-based HIVST as an additional testing option and to explore the HIV testing preferences among MSM and TGW, as national guidelines are open to the use of an oral-based test kit.^{7 8 10 29}

Furthermore, the study’s findings could likely expand HIV testing options and services for key populations in the Philippines. With the potential adoption of oral HIV testing as an alternative strategy for HIV self-testing, the government can explore new avenues to provide broader access to HIV testing and services. This development can also assist the Department of Health in taking proactive measures to enhance the current testing modalities for HIV testing in the Philippines.

Study aims

Primary aims

The study aims to evaluate the acceptability of oral fluid-based HIV self-testing and to assess the preferred HIV testing modalities, including oral fluid-based HIVST, blood-based HIVST, and the standard of care, community and facility-based HIV testing options among (a) MSM and TGW and (b) never-tested and ever-tested in GMA, Philippines.

Specific objectives

Quantitative

1. Identify the sociodemographic characteristics and additional factors that facilitate HIV testing modality selection.

2. Examine the measures of acceptability, including the satisfaction with the chosen testing modality, the choice of testing modality for the next HIV test, the likelihood of choosing HIVST in the future and the likelihood of recommending the chosen testing modality to a friend.

3. Evaluate the acceptability of testing modalities within the HIV cascade, specifically focusing on reporting rates, HIV seroreactivity, referrals to confirmatory testing and linkages to care and treatment.

Qualitative

• 4 1Determine qualitatively the barriers and facilitating factors that may influence testing modality selection and the acceptability and usability of the chosen modality.
• 4 2Elucidate the quantitative survey data results on the acceptability and usability of various HIV testing modalities through qualitative findings.

Methods and analysis

Study design

The research team will use a mixed-methods approach with an explanatory sequential design. This mixed-methods approach will collect and analyse qualitative and quantitative data, including a cross-sectional study and a case study for the quantitative and qualitative parts. Furthermore, quantitative data will first be ascertained using a pre/post questionnaire format design, followed by qualitative data collection via in-depth interviews (IDIs) to contextualise and expound on the findings of the quantitative results.

Before the HIV testing, participants will be asked to complete the first section (pretesting) of the online quantitative self-administered questionnaire. They will be asked about their preference and acceptability of HIV testing modalities, possible HIV exposure, sexual behaviour, HIV testing history, HIVST knowledge, acceptability and willingness to pay. After the pretesting questionnaire section, participants will receive their preferred HIV testing modality for their actual test.

After the testing, the study participants will complete the post-testing questionnaire, which includes questions on their experience with their selected modality and, if applicable, the HIVST acceptability and usability. These questions are also designed to determine the possible factors that influence the selection of a particular testing modality. In addition, these factors will also aid in the questions for the subsequent IDIs.

Qualitative IDIs will be conducted among a selected subsample of informants who have completed the quantitative questionnaire to explain, expound and contextualise the quantitative data. Qualitative data collection will explore informants’ experiences with their selected HIV testing modality and the reasons for their acceptance of their preferred testing modality and non-selection of the other modalities.

Conceptual framework

We will evaluate the HIV testing preference model to explore various factors, including sociodemographic characteristics, sexual behaviours, HIV knowledge and testing history, HIV test kit usability and willingness to pay. Figure 1 provides a conceptual framework illustrating the relationships among these factors and HIV testing preference. The quantitative portion of the study will identify and validate these factors, with further contextualisation through IDIs.

Figure 1. Conceptual framework for HIV testing preference among MSM and TGW. HIVST, HIV self-testing; MSM, men who have sex with men; TGW, transgender women.

Study population

The study’s KPs will be Filipino MSM and TGW. The two populations will be recruited through physical hotspots and online/web-based platforms. In addition, the data ascertained from these two populations will be separately analysed to assess the uptake of the different HIVST modalities. MSM are individuals assigned male at birth who do not identify as female. TGW are individuals assigned male at birth and who identify as female, regardless of whether they have received gender-affirming hormone therapy or surgery. These target populations contribute to a large margin of cases in the Philippines, particularly for MSM, who comprise at least 80% of the cases in the country as of 2019.³⁰ Furthermore, while there are other populations vulnerable to HIV, such as people who use drugs and sex workers, the study has chosen to focus on MSM and TGW as they are more representative of the majority of cases in the GMA.

Inclusion and exclusion criteria

The following eligibility criteria will be used when recruiting study participants for the study’s quantitative and qualitative portions. Participants must be Filipino citizens who are 18 years or older, currently living and/or working in the GMA, and must be an MSM and/or TGW who self-reports oral, anal and neovaginal sex with at least one assigned male at birth or transgender female.

Participants will self-report criteria through several questions regarding their nationality, age, assigned sex at birth and gender identity. In addition, participants must currently not be living with HIV or must have an unknown HIV status, can read and write in Filipino or English, can provide consent for the study and must be willing to provide contact information for follow-up and linkage to care. To validate the place of residence and work of each participant, they will be asked whether they live and/or study/work in National Capital Region, Central Luzon (Region 3) or CALABARZON (Region 4A). Should the answer be NO, the participants will be excluded, and those answering YES will proceed to two follow-up questions. The first is about their current place of residence and another about the location of their work/study. The options will ask for the following: their region, province and city of residence/work. If both responses are from outside the GMA area, the participant will be excluded.

Additionally, the exclusion criteria will include individuals currently taking either pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), as well as those who received their last dose of PrEP or PEP less than 3 months prior to recruitment. Although the minimum testing age is 15, the research team has decided to exclude minors for this study since local ethics policies require them to present permission from a legally authorised representative. This requirement may introduce unintended harm and/or risk due to the sensitive nature of the study.

Recruitment procedure

The study will aim to recruit participants who still need to be reached through traditional means. Recruitment will take place online and offline to maximise the study’s reach. Online recruitment will be done through social media posts, advertisements and targeted boosting. Profiles in geosocial dating applications will also be used for the online component. For offline recruitment, the research team will visit physical locations such as saunas, massage spas, nightclubs and bars that cater to the target populations to find and recruit participants. In addition, events geared towards the target populations will be recruitment sites in cooperation with the implementing sites and community-based organisations. Figure 2 presents the flowchart of the study from recruitment to the completion of the study.

Figure 2. Flowchart of the study procedures. CBS, community-based screening; FBT, facility-based testing; IDI, in-depth interview; LTFU, loss-to-follow-up; TCS, treatment, care and support.

Data collection procedures

Quantitative: cross-sectional survey

Self-administered questionnaire

The study will create a self-administered questionnaire based on the factors influencing the HIV testing preference model (figure 1). Based on previous research, certain variables will be ascertained and answered in the pretesting questionnaire part of the survey, including sociodemographic characteristics (age, sex at birth, gender identity, living and work area, highest level of education completed), sexual behaviours (sexual activity with a man or transwoman, most recent sexual encounter), history of HIV testing (most recent HIV test, frequency of HIV testing, number of tests in the past 12 months) and knowledge about HIV testing (availability of HIV self-testing, preference for access to HIV testing kits, preference for HIV self-testing). In addition, participants will also be provided basic information on the different HIV testing modalities in the test selection section of the pretesting questionnaire. The usability of HIV testing kits (satisfaction with using the preferred testing kit, willingness to recommend the preferred testing kit and willingness to pay for a testing kit) will be asked in the post-testing questionnaire.^{1213 31},⁴¹

Prior to study implementation, the questionnaires will be pilot-tested among 15 community members who are not part of the study for optimisation. The pilot testing will determine the time it takes to finish the survey, the quality and understandability of the questions, and participant choices. The questionnaires shall be revised based on the feedback of the pilot respondents. The finalised questionnaire will be distributed in English and Filipino using the Qualtrics XM platform. Informed consent detailing the purpose, risks, benefits, methods, services available and other ethical considerations will be included in the pretesting questionnaire before participants can enrol. The pretesting questionnaire will also include questions about the inclusion and exclusion criteria for eligibility, as well as the participants’ preferred HIV testing method for the actual testing.

Outcome assessment

HIV testing and reporting of results

To help their decision making, participants are provided basic information (type of sample, method of collection, etc), on the available HIV testing modalities during recruitment, and in the pretesting questionnaire. Based on the participants’ choice of modality as indicated in the pretesting questionnaire, the participants would each be provided with or referred to one of the following HIV testing modalities:

1. Oral-based HIV self-testing via OraQuick ADVANCE HIV 1/2 Antibody Test; either (i) assisted or (ii) unassisted.

2. Blood-based HIV self-testing via Chembio SURE CHECK HIV 1/2 Assay; either (i) assisted or (ii) unassisted.

3. Community-based screening.

4. Facility-based HIV testing.

For choices A and B, participants can receive the testing kit either on-site (during recruitment) or delivered via courier. A trained provider will guide those who choose assisted during testing, while those who opt for unassisted will just be given written and audio-visual instructions. For those seeking assistance, these can be provided on-site, through a partner facility, or remote via a scheduled video call. Participants selecting choice A will be provided up to two (2) OraQuick ADVANCE HIV 1/2 Antibody Test kits, which are then administered during outreach, at home or the participants’ preferred venue with the following three-step protocol:

1. Sample collection. The OraQuick test materials (test kit, test stand, timer) will be prepared. Participants’ oral mucosal transudate (OMT) samples will be collected by swabbing the OraQuick flat pad against the upper and lower gingival region.

2. Sample insertion. The OraQuick device, impressed with the participant’s OMT sample, will be inserted into the OraQuick test tube until the flat pad is submerged in the proprietary tube fluid. The flat pad will be left in the tube for 20 min.

3. Interpretation. One band next to “C” (control line) and no band on “T” (test line) indicates a non-reactive result; whereas, two complete bands next to “C” and “T” (however faint) indicate a reactive result. No band next to “C” indicates an invalid result and will require repeat testing through another kit. After two invalid results, a participant will be directed to the national standard HIV testing algorithm.

Participants selecting choice B will have their HIV test administered either on-site (during outreach), at home or in their preferred venue. However, they will follow the standard blood-based HIV self-testing modality through the Chembio SURE CHECK HIV 1/2 Assay. In addition, they will also be allowed to choose between assisted and unassisted testing.

Participants opting for choices C and D will instead be referred to the appropriate CBO or facility, respectively. However, participants selecting choice C may receive testing on-site if enrolled through a simultaneous community outreach initiative. Choice C and D procedures will be similar to the standard testing under the National HIV Programme.

After the HIV testing, the participant will be directed to complete the second section (post-testing) of the Qualtrics XM survey questionnaire, where they can report their test results. For participants who will receive a reactive result, a member of the research team will follow-up to determine whether they have: (1) taken a confirmatory test, (2) enrolled in an HIV treatment facility and (3) received and/or are taking antiretroviral therapy medication.

Qualitative: case study

In-depth Interviews

Participants for the IDIs will be selected from individuals who have completed both sections of the quantitative questionnaire and the testing process. The investigators will aim to randomly choose and recruit an equal number of MSM and TGW, including never-tested and ever-tested individuals, who opted for each of the different HIV testing modalities. The lead investigators will conduct the interview following the developed interview guide. The interview will be held using the University’s official Zoom account to ensure added security and confidentiality.

All the IDIs will only be recorded if the participant consents to an audio recording; otherwise, another investigator will manually transcribe the IDIs. The transcriber shall proofread all transcriptions against the recording and/or notes and revise the transcript file accordingly. Subsequently, all transcripts shall be validated by a different research team member for accuracy and quality assurance. Any personally identifiable information will be redacted from the transcript. For interviews in Filipino, English or a combination of both, a research team member will be assigned to translate them into English. Once the translation is completed, another research team member will validate it to ensure proper translation and quality assurance.

The IDIs will focus on the plausible factors affecting the participants’ HIV testing preference. Factors influencing the preference for HIV testing modalities will be assessed, including previous experiences, convenience, privacy and confidentiality. For the factors affecting the acceptability and usability of oral HIVST, ease of use, comfort and perceived accuracy will be examined. These factors will be investigated individually, despite potential overlaps. Online supplemental file 1 shows the in-depth interview guide and discussion questions.¹²

Sample size calculation

Quantitative

Based on the population size estimates, a sample size of 480 MSM and 478 TGW will be needed for the study. It is estimated that there are at least 254 200 MSM and 60 000 TG women who live, work and/or socialise within the Greater Manila Area, making it feasible to collect the required number.⁴² Sample sizes were calculated using Cochran’s formula with a 95% CI, a 5% margin of error and a 50% response distribution for the proportion of participants who opted for HIVST.⁴³ A conservative base estimate of 50% was chosen for the sample size calculations. Additionally, a 20% loss was factored into the sample size calculations to cover the possibility of loss-to-follow-up (LTFU). The researchers will continue recruitment up to the target sample size, including the additional 20% for LTFU. The selection of potential survey participants will use a “first come, first serve” strategy.

Qualitative

IDIs will be conducted from the subset of the quantitative survey participants. The interviews will explore informants’ acceptability and non-acceptability of oral fluid self-testing, the rationale and reasoning behind testing modality preferences, perceived benefits of testing options, thoughts on the reliability of testing results, desired location(s) for testing and willingness to pay, among other factors.

Previous research has shown that the median number of IDIs required to reach 80% saturation is 8 to 10.⁴⁴ This study will conduct eight interviews with each population group and testing modality for at least 80 interviews. Among each group of eight informants, four will be informants who have never tested for HIV or “never tested,” and four will have previously tested for HIV or “ever tested.”

Data management and analysis

Data management strategy

The principal investigator (PI) will be responsible for ensuring the overall quality of the study. It will involve implementing activities, including monitoring data collection procedures and conducting periodic audit checks per the approved protocol. Data collected from transcribed interviews and online questionnaires will also be recorded and stored in a password-protected computer. The PI will also ensure that the data are accurate, complete, legible and collected on time. Data from the online questionnaire or IDIs must be consistent, processed and modified as needed. The PI and the team will perform monthly data validation and cleaning to ensure data accuracy. Additionally, a data audit will take place halfway through and at the end of the data collection period.

Missing data management

All responses in the Qualtrics XM questionnaire will be formatted to ask for forced responses to avoid skipped questions or blank responses. Missing data can still occur in self-report measurements at either the variable or item level, if a participant chooses to provide random answers, or due to differential attrition between the first (pretest) and second (post-test) survey stages. For variable level, missingness happens on a multi-item instrument when all items are missing. For item level, missingness arises when respondents exclude one or more items within a multi-item instrument that measures a variable or an abstract concept.

In addition, survey participants who have any missing data for variables used in the data analysis will be excluded. Generally, if less than 10% of study participants have missing data for one or more analysis variables, the study results should not be significantly affected. Moreover, multiple imputations will be used to handle incomplete or missing data. If more than 40% of observations have missing values, variables with the most missing values will be removed from the analyses. To address attrition, key characteristics (eg, age, key population group, HIV testing history) will be compared between completed and incomplete responses to review any differences and assess any potential bias that may arise. Appropriate adjustments in the analysis will be made to address this if necessary.

Quantitative analysis

Descriptive statistics for age, possible HIV exposure, sexual behaviour, HIVST knowledge, willingness to pay, sociodemographics, measures of acceptability and other relevant variables will be calculated and checked for their distribution to answer the quantitative specific objectives (SO). Study characteristics will be stratified by key population (MSM and TGW) and HIV testing history (ever tester and never tester). Frequencies and percentages will summarise categorical variables. Means, SD, medians, minima, maxima and ranges will summarise continuous variables.

Potential factors associated with the participant’s HIV testing modality selection will be estimated using multinomial logistic regression models, adjusting for potential confounding factors (eg, age, education) to address SO 1. The outcome of interest is the participant’s selected HIV testing modality, with four levels: (1) oral fluid-based HIV self-testing (OraQuick), (2) blood-based HIV self-testing (Chembio), (3) community-based HIV testing and (4) facility-based HIV testing. These models will be fitted to capture residual correlation among measurements between participants, allowing for adjustments in participants with possible similarities (eg, recruitment site or population group). Moreover, the analysis will also account for heterogeneity to help ensure that the model captures differences in participant characteristics that influence the HIV testing modality selection. Both procedures will be done to improve the robustness and generalisability of the model’s findings.

For SO 3, the reporting rate and seroreactivity will be calculated over the total number of participants. In addition, confirmatory testing, linkage to care and treatment will be calculated over the total number of positive participants.

Qualitative analysis

Qualitative thematic analysis methods will be used to analyse the qualitative data collected from the IDIs to address SO 4, providing structured and emergent insights into participants’ HIV testing preferences and acceptability. The analysis will use an inductive approach using data-derived codes. If applicable, a priori codes for retrieving text for critical concepts related to the overall objectives may also be used. A coding frame will be developed based on the question guides and the first few IDIs for analysis. New codes will be added as necessary during transcript analysis. If needed (depending on the complexity of the findings), a qualitative data software programme, such as QSR NVIVO, may be used to organise all qualitative data and prepare the data for analysis. Multiple coders will be used, and procedures will be implemented to check for inter-coding discrepancies. Once all the transcripts have been coded, textual coding reports will be produced. Data reduction techniques will examine codes in detail for subthemes and patterns across the IDIs. Summary reports will be developed, identifying the themes related to the study objectives.

Data triangulation from quantitative and qualitative findings

Data triangulation will integrate the quantitative and qualitative strands in the research protocol to answer SO 5. It will be triangulated by examining both aspects of the data and comparing them for convergence. Qualitative and quantitative data integration at the interpretation and reporting level will occur through joint displays. When integrating through joint displays, the researchers will bring the data together visually to draw out new insights beyond the information gained from the distinct quantitative and qualitative results.⁴⁵,⁴⁸ This visualisation can occur by organising related data in a figure, table, matrix or graph.

Data triangulation will require listing all the relevant findings from each study component and considering where each method’s results converge, offer complementary information on the same issue or contradict each other. It is crucial to look for disagreements between findings from different data collection methods because exploring any apparent inter-method discrepancy may lead to an improved understanding of the research question (see figure 3 for details).

Figure 3. Proposed explanatory sequential mixed-method implementation matrix. MSM, men who have sex with men; TGW, transgender women.

Ethics and dissemination

Ethics approval

The study shall abide by the Principles of the Declaration of Helsinki (2013) and the National Ethical Guidelines for Health and Health-Related Research (NEGHHRR) of 2017. This protocol has been approved by the University of the Philippines Manila Research Ethics Board (UPMREB 2023-0579-01, dated 22 November 2023).

Dissemination

Study findings will be disseminated to relevant stakeholders, as the results of this study can inform the national policy on HIVST scale-up in the Philippines. The team will endeavour to disseminate the study’s results in regional conferences and meetings and publish the abstract, protocol and/or results in peer-reviewed journals.

Discussion

The primary objectives of this study protocol are to assess the acceptability of oral fluid-based HIVST and determine the HIV testing modality preference of MSM and TGW in the Greater Metro Manila, Philippines. The Philippines is currently facing a high number of HIV transmissions, and there is an urgent need to increase case finding. In addition, the introduction of an additional novel self-testing modality that offers an alternative to the current blood-based testing could help expand the choice options for HIV testing in the Philippines. This additional option could overcome the drawbacks and barriers to entry associated with blood-based testing and assist in the downstream steps of the HIV treatment cascade.

Furthermore, the study protocol, being a mixed method, includes a qualitative component that will explore various factors such as sociodemographics, sexual behaviours and health, experiences and attitudes towards HIV testing, knowledge of HIVST kits and other factors that may provide more reflective insights into the reasons and motivations behind the selection of testing modality by MSM and TGW key populations in the Philippines. Additionally, these important factors may not be captured in the quantitative survey, making the qualitative component an essential part of the study. The study’s results will shed light on the preferences and acceptability of the different HIV testing modalities to Filipino MSM and TGW in GMA. Additionally, the results from the study could inform stakeholders and other relevant decision-makers in developing a more focused screening campaign and a more accurate allocation of resources based on actual preferences of key populations, possibly increasing participation from untested and undiagnosed individuals.

Limitations of the study

This study focuses on Filipino MSM and TGW residing in Greater Metro Manila, Philippines, with the potential limitation of excluding individuals without internet access, as the questionnaire is administered online. Consequently, the study may not fully represent the target population, particularly those outside Greater Metro Manila and those without internet access, introducing potential selection bias.

In addition, the study is geographically confined to the top three regions (Greater Metro Manila) with the highest HIV cases. While online outreach and targeted advertisements will cover all areas within Greater Metro Manila, physical outreach activities will be limited to selected hotspots.

Additionally, the study’s focus on MSM and TGW excludes other key populations (sex workers and people who inject drugs) disproportionately affected by HIV in the country, limiting the generalisability of the findings. Another significant limitation is the missing data due to loss-to-follow-up, such as participants not testing, not reporting results or refusing follow-up contacts. Measures to address and analyse missing values will be implemented during data analysis.

Significance of the study

The findings of this study protocol may provide valuable insights that may shape policies aimed at enhancing the delivery of HIV testing and counselling services in the Philippines. Furthermore, the study’s outcomes could significantly contribute to increasing access to HIV testing within the community, particularly among high-prevalence at-risk groups such as MSM and TGW. Moreover, enhanced testing efforts, coupled with broader treatment availability, are anticipated to reduce the community viral load, thereby lowering the overall risk of HIV transmission within these key populations.