This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV have low antiretroviral treatment adherence in South Africa due to limited skills in managing disclosure and prevention behaviors with sexual and romantic partners. As a result, there is a high HIV transmission risk within HIV-discordant partnerships, but an existing intervention may address these outcomes, if adapted effectively. Healthy Relationships (HR) is a behavioral intervention that was originally delivered in groups and in person over 5 sessions to develop coping skills for managing HIV-related stress and sexually risky situations, enhance decision-making skills for HIV disclosure to partners, and establish and maintain safer sex practices with partners. HR effectively improves prevention behaviors but has yet to be tailored to a non-US context.
We aim to adapt HR into a new culturally grounded intervention entitled
The study will have 2 aims. For aim 1—adaptation—we will use a human-centered design approach. Initial intervention tailoring will involve integrating Undetectable=Untransmittable and pre-exposure prophylaxis education, developing intervention content for a videoconference format, and designing role-plays and movies for skill building based on preliminary data. Afterward, interviews and surveys will be administered to GBMSM to assess intervention preferences, and a focus group will be conducted with health care providers and information technology experts to assess the intervention’s design. Finally, a usability test will be performed to determine functionality and content understanding. Participants will be GBMSM living with HIV (n=15) who are in a relationship and health care providers and information technology (n=7) experts working in HIV care and programming with this population. For aim 2, we will examine the feasibility of the adapted intervention by using a pilot randomized control design. There will be 60 individuals per arm. Feasibility surveys and interviews will be conducted with the intervention arm, and behavioral and biomedical assessments for relationship and treatment adherence outcomes will be collected for both arms. All participants will be GBMSM living with HIV who are in a relationship with an HIV-negative or unknown status partner.
Intervention adaptation began in August 2021. Initial tailoring and the refining of GBMSM intervention preferences were completed in December 2021. Usability and feasibility assessments are due to be completed by March 2022 and February 2024, respectively.
GBMSM need efficacious interventions that tackle partnership dynamics, HIV prevention, and treatment outcomes for antiretroviral treatment adherence and viral suppression in South Africa. Harnessing everyday technology use for social networking (eg, videoconferences), Undetectable=Untransmittable education, and pre-exposure prophylaxis to update an existing intervention for South African GBMSM has the potential to strengthen relationship communication about HIV treatment and prevention and, in turn, improve outcomes.
DERR1-10.2196/36845
The past 20 years have seen a growth in HIV research and programmatic attention focused toward gay, bisexual, and other men who have sex with men (GBMSM) in Southern Africa. What was long considered a generalized epidemic among heterosexual individuals is now recognized to be paralleled by a devastating epidemic among GBMSM [
South African GBMSM are often not adherent to their ART while in relationships because of poor skills for managing HIV disclosure and prevention with partners [
In previous work, Daniels et al [
Addressing partnership dynamics may improve the effectiveness of HIV treatment interventions for GBMSM in South Africa. However, few HIV treatment interventions have been implemented with African GBMSM, and a growing body of global evidence suggests that GBMSM partnership dynamics are fueling HIV transmission such that one-third to two-thirds of new HIV infections among GBMSM occur within serodiscordant partnerships [
Healthy Relationships (HR) is a behavioral intervention that was originally delivered in groups and in person over 5 sessions. HR aims to (1) develop coping skills for managing HIV-related stress and sexually risky situations, (2) enhance decision-making skills for HIV disclosure to partners, and (3) establish and maintain safer sex practices with partners. HR integrates edited movie scenes for participants to view and role-plays that model effective communication skills [
In our study, HR will be adapted and pilot-tested as a videoconference-delivered intervention for HIV-positive GBMSM with partners by using a design process that incorporates local voices to create an intervention that reflects the lived realities of South African GBMSM. This project aims to develop HR for GBMSM in South Africa into a new, culturally adapted intervention entitled
Web- and group-based HIV interventions are demonstrating feasibility in diverse African settings. SMART Connections is a 5-session ART adherence and retention in care intervention that was delivered to HIV-positive youth in Nigeria through closed, secret Facebook group sessions [
To further support the proposed delivery method of their intervention, Daniels et al [
Herein, we present our protocol for intervention adaptation followed by a pilot randomized controlled study to assess SOAR feasibility for South African GBMSM. The findings from our study will inform a larger clinical trial for determining SOAR effectiveness in improving HIV disclosure, relationship communication, and viral suppression.
SOAR will be guided by social cognitive theory (SCT), which posits that cognition, behavior, and environment interact and influence health outcomes, like HIV risk reduction, disclosure, prevention, and ART adherence [
Our study has been reviewed and approved by the University of Cape Town Review Board (approval number: FWA00001938) with reliance by the institutional review boards at Arizona State University (approval number: STUDY00014539) and the University of Michigan (approval number: HUM00208997).
The study will involve intervention adaptation (aim 1) followed by a randomized controlled trial (aim 2) to assess feasibility. For adaptation, we will use a human-centered design (HCD) approach. HCD is a multistep approach to gathering different perspectives and experiences from key stakeholders (GBMSM and health care and information technology [IT] specialists) and end users (GBMSM in relationships) for iterative intervention adaptation to include technology integration in context for implementation [
HR tailoring will be completed by the research staff to include the integration of U=U and PrEP education and messaging, and based on preliminary research, contextually relevant movie segments and role-plays for coping and risk assessment skill building will be developed. Additional intervention components that will be developed include a partner referral letter for HIV testing, action plans, and a monthly videoconference group check-in. The partner referral letter will provide access to HIV testing, U=U and PrEP education, and related local services that are available in the area and be designed to be provided by the participants, who will self-report delivery only [
We will conduct 15 individual interviews with GBMSM and 2 focus group discussions with a total of 12 health care providers, program leaders, and IT experts. Interviews will be conducted with GBMSM to assess their experiences with and preferences for disclosure and their interests in and considerations for participating in an intervention that builds HIV disclosure skills and is delivered via videoconferences in a group setting. Additionally, by using the findings from the interviews, a study-specific survey will be developed to refine GBMSM participants’ preferences for the intervention. Afterward, focus groups will be conducted with health care providers, program leaders, and IT specialists who provide HIV care or manage GBMSM programming in Eastern Cape and on the internet. The focus group discussions will involve a presentation of the initially tailored HR from the initial tailoring phase, and we will seek feedback on session content based on their experiences with working with GBMSM in this setting. The findings from interviews, focus groups, and study-specific surveys will be integrated into the intervention and then assessed for usability.
The intervention will be pretested for usability over a 5-week period in 2-hour sessions (1 session per week). A group check-in will then be conducted 3 weeks after participants’ last session (week 8). A group of participants (n=7) will complete all 5 sessions together on Zoom (Zoom Video Communications Inc). During the last session, participants will be informed of the date and time for the group check-in session. During the pretest, the interventionist will monitor participants’ engagement and follow up with participants who miss a session. Before beginning the pretest, each participant will provide their mobile number to receive group session reminders. All intervention sessions and group check-ins will be video recorded for analysis. All participants will receive a data plan to complete this task.
After the pretest, interviews will be conducted with GBMSM participants, and a focus group will be conducted with health care and IT experts. The interviews with GBMSM participants will cover the following six intervention usability domains [
There will be 15 HIV-positive, partnered GBMSM recruited from HIV outreach activities that are led by a local collaborating organization. Further, 12 health care providers, program managers, and IT experts who work in GBMSM programming in Eastern Cape will be purposely recruited. For the usability test, there will be 7 GBMSM participants recruited from the initial 15, and all 12 health care providers, program managers, and IT experts will be recruited. All participants will complete written informed consent and will receive R150 (around US $10) as a travel reimbursement for completing the study activities and a R150 (around US $10) data plan to support their session attendance.
SOAR will be assessed by conducting a pilot randomized controlled trial that includes an attention-matched control arm (
Speaking Out & Allying Relationships (SOAR) Intervention Design for Feasibility Pilot-Testing. ART: antiretroviral treatment; VL: viral load.
Participants will receive the intervention for 5 weeks in 2-hour sessions (1 session per week). Participants will complete the session with the same group of GBMSM. After providing consent, participants will complete Zoom training, which will include a simulated conversation with the interventionist, who will use Zoom in the same room as the participants. Then, each participant’s smartphone will be assessed and set up for compatibility for Zoom. Participants will be notified that they will receive an SMS text message reminder 12 hours before each session. At 1 hour before a session, participants will receive an SMS text message with the Zoom link for that session. Participants will complete several self-assessments and develop an action plan during the intervention. Participants will be provided with the partner referral letters via SMS text messaging (REDCap [Research Electronic Data Capture]; Vanderbilt University) or in paper form (their choice) at the start of the study; multiple copies of the referral letters may be requested throughout the study.
During the last intervention session, participants will be reminded that they will complete group check-ins (n=3) via Zoom. The dates and times will be provided during the session and then sent via SMS text messages to their mobile phones. Similar to the session procedures, participants will receive an SMS text message reminder 12 hours before a group session and a Zoom link for that session 1 hour before each session.
The control arm will maintain their standard of care and receive information that focuses on topic areas like exercise, nutrition, chronic disease, and sexuality. This content will be based on the South African Ministry of Health B-Wise website (B-Wise) [
Feasibility is the primary outcome for the study, and the secondary outcomes relate to relationship communication, ART adherence, and changes in HIV viral load. Feasibility will be assessed for intervention participants, whereas the secondary outcomes will be assessed for both study arms. Survey measures, interviews, and a biomedical marker of viral load will be used.
There are 4 domains of feasibility—feasibility [
In order to understand the feasibility domains, we will conduct 30-minute interviews with purposively selected intervention arm participants (n=30) based on their intervention engagement at baseline, midintervention, and postintervention [
Although our study is not powered to detect changes in these areas, the outcomes from these measures will identify potential directions of effect and inform power calculations for a future efficacy trial. Central to the intervention is creating skills for GBMSM living with HIV to talk to their partners about HIV. The key area—relationship satisfaction—will be assessed by using a 10-item scale that assesses satisfaction with both the partner and the relationship [
Based on our experience from prior studies, we expect around a 23% loss to follow-up, which will result in 92 participants; therefore, we expect to retain 46 participants per group from enrollment through follow-up at 28 weeks. Like other pilot studies, ours is not powered to show the efficacy of the intervention in the study population; the aim of the study is to establish feasibility and the preliminary impact on HIV treatment outcomes before moving to a larger efficacy trial powered for clinical outcomes. We will be able to assess the preliminary impact of SOAR on ART adherence, behavioral measures, and viral load measures. To this end, our sample size (46 participants per group in the randomized controlled trial, yielding data on 92 participants) will yield 70% statistical power with a type 1 error rate at .05 to show a difference between a behavior frequency of 30% in the attention-matched control group and a behavior frequency of 55% in the intervention group for all outcomes.
All participants will be (1) GBMSM; (2) those aged ≥18 years; (3) those who have been in a relationship for more than 1 month; (4) those who own a smartphone; (5) those who are comfortable with group discussions about HIV; (6) those living with HIV, as determined via confirmatory testing using OraQuick (OraSure Technologies) during screening; (7) those who live in Eastern Cape province; and (8) those who have been prescribed ART but are suboptimally adherent, as measured by a visual analog scale [
Intervention adaptation began in August 2021, and initial tailoring and the refining of GBMSM intervention preferences were completed in December 2021. Usability and feasibility assessments will be completed by March 2022 and February 2024, respectively.
There are poor HIV treatment outcomes for GBMSM in South Africa, given the high HIV prevalence and low ART adherence rates [
The innovation of the proposed intervention—SOAR—arises from 4 critical, interconnected knowledge gaps. First, it will address the lack of efficacious interventions that address partnership dynamics and, in turn, affect HIV prevention and treatment outcomes for ART adherence and viral suppression among GBMSM in a highly stigmatized, resource-limited setting in South Africa [
There is an urgent need to develop interventions that provide GBMSM with the behavioral skills for addressing the management of HIV disease while in relationships. If feasible, the proposed intervention has the potential to be implemented in other sub-Saharan African settings with high HIV prevalence rates among GBMSM. Empowering GBMSM to manage their ART adherence and serostatus disclosure while they build a relationship has the potential to be a low-cost and sustainable mechanism for increasing the uptake of HIV care among GBMSM—a group that is currently overlooked in programmatic efforts in sub-Saharan Africa.
antiretroviral treatment
gay, bisexual, and other men who have sex with men
human-centered design
Healthy Relationships
information technology
mobile health
pre-exposure prophylaxis
Research Electronic Data Capture
social cognitive theory
Speaking Out & Allying Relationships
Undetectable=Untransmittable
The study is funded by a National Institutes of Mental Health grant (1 R34 MH125790-01A1) that was awarded to JD and RS (coprincipal investigators).
None declared.