The Joint United Nations Program on HIV/AIDS (UNAIDS) and partners are focused on ending the HIV/AIDS epidemic using a variety of strategies [1,2]. However, over the past decade, it has become increasingly clear that the global HIV response is inadequately engaging men [3]. This shortfall has been largely due to a lack of emphasis on acceptable and approachable ways to reach men, which has greatly affected clinical and public health outcomes and targets. Global evidence shows that, when compared to women, there are 1 million more men living with HIV who are unaware of their HIV status and 1.8 million more men not on treatment [1,2]. More AIDS-related deaths have occurred among men than among women over the last decade [4,5].

In 2023, the 95-95-95 strategy for HIV testing and treatment was 83-86-94 among men aged ≥15 years versus 91-91-94 among women counterparts [6]. However, in 2022, a meta-analysis of 129 studies from sub-Saharan Africa (SSA) found that 49% (95% CI 0.41-0.58) of men did not know their HIV status, 58% (95% CI 0.51-0.65) were not on treatment, and 21% (95% CI 0.19-0.23) on treatment were not virally suppressed [7]. The observed difference may be attributable to the meta-analysis incorporating studies conducted between 2014 and 2020, whereas the comparison data are derived from 2023 program reports. Notably, gender disparities in HIV prevention and treatment outcomes have persisted through 2024. Recent estimates indicate that 84%, 87%, and 94% of men know their HIV status, are on treatment, and are virally suppressed, respectively, compared with 92%, 91%, and 95% of women, according to UNAIDS. Suboptimal HIV prevention and care services for men disproportionally increase both their risk of death and HIV transmission [4]. Unfortunately, undiagnosed and untreated HIV among men leads to continued transmission of HIV, especially to adolescent girls and young women, the most susceptible and affected age group for new HIV infections [4,8]. Therefore, diagnosing and treating HIV in men is not only essential for promoting men’s health but also for breaking the cycle of HIV transmission [4,9].

In Eastern and Southern Africa, the HIV epidemic is largely heterosexually transmitted, and heterosexual men are greatly affected [10,11]. However, HIV services increasingly target key populations [12-15], with limited emphasis on heterosexual men [7,16-18]. Fishing communities are especially affected; for example, the Kalangala Islands have an HIV prevalence of 12%, twice the national average of 5.1%, and an HIV incidence of 231 per 100,000 persons [19-21]. Additionally, men make up four times the population of women in the islands, with 48.4% of them unaware of their HIV status [20,22-24].

Compared to women, men and boys are less likely to test for HIV, initiate antiretroviral therapy, and remain engaged in care [4,25,26]. A significant body of research and experience shows a range of complex, multilevel barriers to male engagement in HIV-related services [4,26-28]. These include fear of knowing one’s HIV status and related stigma [29,30], and prevailing cultural, social, and gender norms—such as equating illness with “weakness” and viewing clinical settings as “female” spaces [31,32]. Men in Africa often assume their status matches their partner’s [33] and worry about loss of income from taking time off work [30,34-37]. Health systems also create structural barriers by focusing on reproductive-age women who can access care through antenatal care, and maternal and child health programs—entry points that do not exist for men [4]. Limited clinic hours and facility-based service models further exclude men, especially those who work [4,26].

HIV testing is the gateway to prevention and care. The World Health Organization recommends HIV self-testing (HIVST) as an additional HIV testing approach, and it is feasible and acceptable among various populations, including heterosexual men [38-40]. Over 4.8 million test kits have been distributed in SSA, including Uganda [41]. However, a recent systematic review found that, despite high uptake, many questions remain about HIVST’s effectiveness in reaching historically underserved men and ensuring linkage to prevention and care [42].

Community-based HIV testing services (CHTS), such as mobile and home testing [4], show high potential for reaching men [4,38]. Men prefer CHTS over facility-based testing [26,38-40,43,44] due to its convenience and lower stigma [40,44-48]. Specifically, CHTS improves testing among low- and middle-income men, young men, and those who would otherwise avoid health facilities [40,44-48]. Still, broader reach and linkage to care mechanisms are lacking [38].

Peer intervention approaches, which use individuals with similar demographic and social backgrounds to the target population, have proven effective in promoting behavior change, sustaining reductions in HIV risk behaviors [49,50]. Peer-led education enhances knowledge exchange, reduces stigma, builds trust, and supports uptake of services such as HIVST [40,44,51-53]. Notably, community-based peer support has improved HIV service uptake and adherence in several settings [54,55].

Despite this progress, affordable and scalable combination programs tailored for heterosexual men in high-burden settings remain scarce [56]. Thus, innovative community-based strategies are urgently needed to improve men’s HIV testing and linkage to prevention and care services. Barbershops offer informal, easily accessible (ie, convenient location and hours of operation), and collegial spaces where men often feel safe to talk about personal health issues, and the majority use the same barber most of the time [57]. Studies in the United States on barbershop-based health promotion interventions for Black men showed that barbershop-based interventions achieved satisfactory recruitment and retention of men in health services [58]. Another study in the United States found barbershop business venues appropriate for HIVST promotion and distribution [59].

Therefore, the purpose of HIV Prevention Trials Network (HPTN) 111, also known as TRIM (Testing a Barbershop-based HIV Prevention Initiative Among Men), was to develop and assess the feasibility, acceptability, and preliminary effectiveness of a barbershop-based HIV prevention initiative among heterosexual men in a high–HIV-prevalence setting. The study leverages trusted relationships between men and their barbers to deliver a prevention package consisting of HIV education, HIVST distribution, and barber-led peer group sessions. This protocol responds to a critical need to develop focused interventions to engage men in HIV prevention and care to bring male HIV prevention and care outcomes on par with those of women.

The primary objective was to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative. The secondary objectives were to compare completion of self-initiated HIV testing between intervention and control groups, evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, compare interest in or use of HIV prevention services between intervention and control groups, and assess interest in long-acting preexposure prophylaxis (PrEP) among all participants and by study arm. The exploratory objective was to evaluate the preliminary effectiveness of the intervention on incident sexually transmitted infections (STIs).

HPTN 111 (TRIM) was a pilot study conducted through the HPTN. HPTN 111 is funded by the National Institute of Allergy and Infectious Diseases (NIAID), under the National Institutes of Health. NIAID provides technical assistance and coordination of the study, including regulatory reviews and study conduct oversight. HPTN 111 is registered on ClinicalTrials.gov (NCT06148584). The study is based on the capability, opportunity, or motivational components of the Capability, Opportunity, and Motivation Model of Behavior Change (COM-B; Figure 1) [60]. The COM-B postulates that changing the behavior of an individual, a group, or a population requires changing either their capability, opportunity, and/or motivation needed to perform the behavior [61]. Therefore, in this study, we used the COM-B to provide a barbershop-based HIV prevention intervention to men living in a high heterosexual HIV incidence setting and who could benefit from HIV prevention services. The initiative aimed to increase men’s capability, opportunity, and motivation through the provision of HIV education and prevention measures directly from their barbers and based at their barbershops. This study will provide valuable information about the feasibility and acceptability of a barbershop-based HIV prevention initiative and the potential for scale-up in other settings where barber-client relationships are an important component of men’s social structure. Lastly, we followed the SPIRIT (Standardized Protocol Items: Recommendations for Interventional Trials) reporting guidelines during the drafting of this protocol paper.

HPTN 111 (TRIM) is a cluster randomized trial testing the feasibility and acceptability of a barbershop-based HIV prevention intervention among heterosexual men who have certain risk factors for HIV acquisition. The study was conducted in Kalangala district, Uganda, among barbershop-going men. Barbershops acted as clusters, and 18 purposively selected barbershops were randomized in a 2:1 ratio to the intervention or control group (Figure 2).

Men enrolled from the intervention barbershops received a barbershop-based HIV prevention intervention from their barber, while those enrolled in control barbershops received standard-of-care (SoC) HIV services. At intervention barbershops, trained barbers provided HIV status-neutral education, distributed HIVST kits at the barbershop, and led peer group sessions. The SoC services included existing HIV prevention services—namely, HIV testing and related services from nearby health facilities. All enrolled participants were followed for 12 months with biannual study visits at a designated study clinic. Intervention barbers also had quarterly follow-up visits to assess social impacts, acceptability, and feasibility of the intervention, and interviews to help better understand their experience within the intervention. Study objectives and corresponding end points are provided in Table 1.

HPTN 111 (TRIM) is a pilot study with a primary objective of assessing feasibility and acceptability, measured in the intervention group only (12 barbershops). The sample size was determined based on the following two key considerations: (1) logistical and implementation feasibility [62] and (2) sufficient power to detect differences in a key secondary outcome of HIV testing uptake. A total of 18 barbershops were to be strategically selected, reflecting the number that could be feasibly supported by the study team and within the available budget, as guided in feasibility studies [63]. Selection would be guided by the predefined eligibility criteria, with additional consideration for logistical efficiency. Specifically, barbershops should not be located excessively far from one another, yet should also avoid being in very close proximity. A minimum separation radius of approximately 5 km between sites would be considered to prevent contamination between intervention and control barbershops. While logistical feasibility was the primary driver, to inform client recruitment targets, we also assessed the number of participants per shop needed to detect meaningful differences in HIV testing between study arms, defined as a difference between arms of 20% in the proportion of participants self-initiating HIV testing [63]. A 2:1 randomization was applied, which both increased the number of intervention shops contributing data on feasibility and acceptability and allowed comparisons between arms on secondary outcomes. Enrollment targets of at least 10 participants per each of the 18 barbershops were based on the key considerations above, as well as maintaining at least 80% power for the HIV testing analyses under a variety of possible scenarios (Multimedia Appendix 1). Therefore, each shop would recruit at least 10 participants to reduce the variability in sample size between barbershops, and the protocol team would be informed that it is optimal for power if the 250 participants are evenly distributed across the 18 barbershops, although the variability in the barbershop and village sizes might prevent this.

The study team obtained administrative approval and permission from local leaders to engage various communities and stakeholders in the study area (Kalangala district). This process involved barbershop assessment and selection, district and community stakeholder engagement, and barber training. The study team conducted stakeholder engagement meetings organized with the support of district and local leaders. Stakeholders included local and religious leaders, community representatives from fishing communities, boda-boda cyclists, palm plantation workers, nongovernmental organizations, and village health teams. Meetings were used to discuss perceptions, attitudes, and challenges surrounding the barbershop-based HIV prevention initiative and possible ongoing mitigation strategies.

Participating barbershops were purposively selected on Bugala Island (the largest island in Kalangala District) based on set criteria (Textbox 1) assessed by the study team. The barbershops were largely selected from busy trading centers/towns and landing sites. The barbers participating in each shop were also required to meet set criteria listed in Textbox 1.

On completion of the barbershop assessment and selection, barbers from the 18 selected barbershops were further engaged and trained through consultative and participatory approaches. They were engaged to assess commitment and trained on the study overview, general HIV education, communication skills, and study recruitment requirements. The study team used didactic presentations, illustrations, group discussions, and role plays for these trainings.

Barbers from barbershops assigned to the intervention group received additional training on the implementation of the intervention. Pre- and posttraining assessments were used to ensure that barbers had sufficient knowledge about HIV and the intervention before participant recruitment. Training was ongoing during the study, with study staff providing support to barbers and assessing knowledge and confidence in participant recruitment and intervention delivery. Refresher training and cross-sharing with other barbers were completed if knowledge gaps were identified.

The randomization procedures assigned the 18 selected barbershops to either the intervention or control arm in a 2:1 ratio. Due to the relatively small number of units being randomized (n=18), covariate-constrained randomization was used to balance 3 barbershop characteristics between treatment groups: the estimated population of the village or town where the barbershop is located, the average number of customers a barber served per day (as reported by the lead barber), and the estimated travel distance between the barbershop and the nearest health facility (in km). The restrictions would ensure that the difference between groups is within 300 for the average village population, within 4 for the average number of clients per day, and within 0.75 km for the average distance to the nearest health facility.

Randomization was done in 2 stages. In the first stage, the shops were allocated into 3 groups of 6 shops each using covariate-constraint randomization described above. In the second stage, a public randomization event was conducted, and 2 groups (12 shops total) were assigned to the treatment group, and 1 group (6 shops) was assigned to the control group. The first stage of randomization was executed by statisticians at Fred Hutchinson Cancer Center; the second stage involved barbers publicly drawing opaque balls from a transparent bucket to randomly determine treatment group assignment, ensuring transparency and fostering community engagement.

Due to the nature of the intervention, neither barbers nor study participants were blinded. Barbers were asked not to disclose their treatment assignment during recruitment activities; however, because of the public randomization process and visible delivery of the intervention to other clients, clients would become aware of their barbershop’s treatment assignment prior to enrollment.

The HPTN Ethics Working Group developed the HPTN Ethics Guidance for Research, a network-wide ethical principles document, which guided the HPTN 111 (TRIM) study conduct.

The protocol and the informed consent forms (ICFs) were reviewed and approved by the HPTN Scientific Review Committee with respect to scientific content and compliance with applicable research and human participants’ regulations.

The protocol, site-specific ICFs, participant education and recruitment materials, other requested documents, and any subsequent modifications were reviewed and approved by the Joint Clinical Research Center (JCRC 2023-54) and the Johns Hopkins Medicine (IRB00420132) and cleared by the Uganda National Council for Science and Technology (HS3430ES), which are responsible for oversight of research conducted at the study site.

After initial review and approval, the responsible institutional review boards (IRBs)/ethics committees will review the protocol at least annually. The investigator will make safety and progress reports to the IRBs/ethics committees at least annually and provide a study termination or completion report within 3 months after the study is completed. The annual reports include the total number of participants enrolled in the study, the number of participants who completed the study, all changes in the research activity, and all unanticipated problems involving risks to participants or others. The study site submits documentation of continuing review to the Division of AIDS (DAIDS) Protocol Registration Office, in accordance with the current DAIDS Protocol Registration Policy and Procedures Manual.

All participants provided informed consent prior to their involvement in any study procedure (Multimedia Appendix 2). We ensured participant privacy and confidentiality by using anonymized and deidentified data. Participant data, including ICFs, are kept under lock and key and only accessed by the research team or authorized personnel. Participants were reimbursed and compensated for the time spent at the study site at the rate approved by the IRB.

Participants in the intervention group received the HIV prevention intervention from their barber. The intervention includes (1) status-neutral HIV education and referral information for HIV services, (2) distribution of HIVST kits through the barbershops, and (3) barber-led peer group sessions.

Participants in the control group would not receive any HIV prevention services from their barbershop or barber. During study visits at the clinic, they received counseling on routine HIV services, including HIV testing, HIVST kits, and other HIV prevention services available at nearby health facilities. Barbers in the control group were not notified about participants enrolled from their shops and were withdrawn from the study upon completion of the enrollment phase (see Multimedia Appendix 4 for participant schedule of events).

The study aimed to achieve participant retention of 90% at week 26 and week 52 visits. Strategies such as the collection of full locator information for participants, flexible study clinic hours, and the option for off-site visits would be used. However, to prevent undue influence in HIV prevention-seeking behaviors, the study team limited contact with participants between study visits.

Barbers in this study had a unique role as recruiters, implementers of the intervention, and study participants. Therefore, barbers participating in HPTN 111 (TRIM) carried out a series of administrative and study-specific activities. Barbers/barbershop owners and the study team signed a memorandum of understanding to clearly outline expectations of both parties before the commencement of study activities. All participating barbers also completed written informed consent to ensure they fully understood and voluntarily agreed to participate in the research procedures required throughout the study.

Initially, study staff collected basic information about each participating shop, such as location, total number of clients, hours of operation, cost of services, etc. At baseline, barbers provided demographic information and completed a questionnaire on the acceptability and feasibility of the intervention. At the end of the recruitment period, barbers were asked to complete brief questionnaires about their recruitment experiences. Barbers in the intervention group remained in the study and completed brief questionnaires on acceptability, feasibility, and social impacts of delivering the intervention approximately quarterly during the study follow-up. Intervention barbers also participated in individual in-depth interviews at approximately 6 and 12 months after starting intervention delivery to further understand their views on feasibility, acceptability, facilitators and barriers, and overall experiences of delivering the intervention (see Multimedia Appendix 5 for barber-specific schedule of events and Multimedia Appendix 6 for barber in-depth interview guide). Intervention barbers completed a simple checklist (Figure 3) of the services provided to each client enrolled in the study each time the participant visited the barbershop. The checklist did not contain any direct identifiers of the clients and was stored in a lockable cabinet at the shop, to be collected weekly by study staff.

HPTN 111 (TRIM) data were managed in REDCap (Research Electronic Data Capture; Vanderbilt University) Cloud, a platform used by the HPTN Statistical and Data Management Center to receive and manage study data. The study site completed electronic case report forms (CRFs) by entering data into the REDCap Cloud study database. Data would be entered directly into the study database, collected first on paper CRFs and then entered into the study database, entered directly by study participants (ACASI responses only), and/or entered into the study database based on other non-CRF source documents (eg, laboratory reports, testing logs, and chart notes).

The primary objective of HPTN 111 (TRIM) is to assess the feasibility and acceptability of a barbershop-based HIV prevention intervention. To achieve this, a variety of end points will be assessed (Table 1).

To assess feasibility and acceptability of the intervention, the following were assessed from participants in the intervention group: participant responses from surveys at week 26 and week 52 regarding acceptability of the intervention, barber responses from surveys assessing feasibility and acceptability of delivering the intervention, recruitment rates during enrollment and participant retention in the study at week 26 and week 52, and the frequency of barber-participant interactions (Multimedia Appendix 7). These outcomes were prespecified and will be summarized and described, but specific progression criteria or targets for these outcomes were not prespecified, which is a limitation driven by the novelty of this intervention. The study also assessed the effectiveness of the intervention on changes in HIV testing and use of prevention services. Self-reported sexual behaviors associated with HIV incidence and STI incidence rates will also be compared to SoC.

For end points involving comparisons between groups, as well as those assessed only within the intervention group, analyses will follow intention-to-treat principles. Formal comparisons will account for the clustering by aggregating data at the barbershop level and adjusting for the covariates constrained by randomization [67]. No interim analyses are planned. Secondary end points (Table 1) will be assessed using the same statistical methods. Because feasibility and acceptability outcomes overlap with critical information about study conduct, certain data, such as recruitment and enrollment summaries and information on the frequency and quality of intervention delivery by the barber—would be shared with investigators and study staff. Summaries of other end points not related to study conduct (eg, self-initiated HIV testing) would remain unavailable to investigators and study staff for the duration of the trial. Data and safety monitoring procedures for the trial will involve summaries of reported outcomes and social impacts. Reporting of end points not related to study conduct would be available only to members of the study monitoring committee (SMC) for this study and will be withheld from study investigators and staff members.

Qualitative interviews were digitally recorded, transcribed, translated where necessary, and analyzed systematically. A hybrid thematic analysis approach, combining deductive and inductive coding strategies [68], was used to analyze the data. The intervention itself is guided by COM-B [69]. Therefore, our analytic framework incorporated both deductive coding informed by COM-B constructs and inductive coding.

Emergent themes not predetermined by the framework, such as trust in barbers, social cohesion within fishing communities, mobility between islands, or unintended social impacts, were identified through open coding. Thematic analysis proceeded through the following stages [70]: (1) review of interview debrief reports, (2) familiarization with transcripts, (3) generation of initial codes, (4) development and refinement of a codebook, (5) double coding of selected transcripts to enhance analytic rigor and for determination of interrater reliability among the coders, (6) identification and refinement of themes, and (7) interpretation of themes in relation to feasibility, acceptability, and preliminary effectiveness.

This hybrid approach allowed theoretical alignment with the COM-B while ensuring contextual sensitivity to the lived experiences of participants in Kalangala. Such integration is consistent with implementation science methodologies that combine theory-driven and data-driven analysis [71].

Determination of saturation included descriptive saturation, interpretive saturation, and team-based review. Descriptive saturation was assessed based on no new themes emerging from successive interviews and would be implemented by team-based reviews of interview debrief reports, which were discussed at weekly team meetings. Similarly, at the weekly team-based meetings, which included the protocol team and the interviewers, interpretive (meaning) saturation was assessed. Meaning saturation occurs when themes are fully elaborated, and additional interviews do not provide new depth, nuance, or variation [72]. The team used the interview debrief reports to document thematic development, review variation across purposively selected subgroups (eg, age groups, different barbershops, and levels of HIV prevention uptake), and determine whether thematic explanations sufficiently captured contextual complexity. This guided the team in determining that saturation had been reached.

An SMC conducted interim reviews of study progress, including participant accrual, retention, social harms, and quality of data collection. Reviews occurred approximately every 6 months. The SMC provided recommendations on study conduct to ensure that the study can meet the primary objectives.

Due to the minimal-risk nature of the study and absence of a biomedical intervention, there was no centralized reporting of adverse events. However, the study site would report all adverse events and social harms according to local IRB and regulatory requirements.