HIV InfectionsNCT07226323
Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa
A study testing WeCare in people with HIV Infections and Mental Health, run by Emory University at 1 site in South Africa.
Trial summary
The goal of this clinical trial is to learn if the WeCare intervention-an adapted Friendship Bench program that integrates problem-solving therapy, minority-stress-informed content, and explicit PrEP/ART adherence skills-improves mental health and HIV medication adherence among men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Mental Health
- What is being tested?
- WeCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Dec 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- reports sexual intercourse with a man in the past 6 months
- reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months
- ability to communicate in English
- current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic.
- HIV positive participant only: unsuppressed HIV viral load (HIV-1 RNA viral load ≥200 copies/mL) in the sample collected in the past six months
Show all 9Show fewer
- HIV negative participants only: Self-reported challenges adhering to daily oral PrEP (i.e miss 3 or more tablets per week)
- Moderate symptoms of depression during past 2 weeks (score on the PHQ-9 ≥10 and <20)
- Ability to understand and provide informed consent.
Who cannot join
- Presently engaged in mental health therapy.
- Participated in qualitative phase of WeCare study (AUR2-18-419) or open-pilot (present study).
- Refuses audio recording of the in-person or online individual counselling session
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Aurum Institute
Johannesburg
Eduard Sanders, : +254-723-593-762, ESanders@auruminstitute.org
About this study
The goal of this clinical trial is to learn if the WeCare intervention-an adapted Friendship Bench program that integrates problem-solving therapy, minority-stress-informed content, and explicit PrEP/ART adherence skills-improves mental health and HIV medication adherence among men who have sex with men (MSM). It will also assess the safety, acceptability, and feasibility of delivering WeCare through trained lay coaches in community clinics.
Main questions the trial aims to answer:
- Does WeCare reduce symptoms of depression and anxiety among MSM?
- Does WeCare improve PrEP and ART adherence and increase rates of viral suppression among participants on ART?
- Is WeCare acceptable, feasible, and safe when delivered by lay coaches in POP INN clinics compared with usual care?
Read the detailed description
Men who have sex with men (MSM) in sub-Saharan Africa face very high HIV incidence and prevalence, with South Africa carrying the largest national burden and an estimated ~30% HIV prevalence among MSM. National policies in South Africa endorse universal test-and-treat and prioritize MSM for Pre-Exposure Prophylaxis (PrEP) and Anti-Retroviral Therapy (ART), but care cascade indicators and adherence outcomes for MSM lag behind national averages, indicating a need for differentiated, targeted service approaches.
Common mental health problems are prevalent among MSM and are strongly associated with poorer PrEP and ART adherence. Randomized and quasi-experimental trials in the region show that lay-delivered or nurse-delivered mental health interventions can reduce depression and improve ART adherence and viral suppression, while observational studies link poor mental health to lower PrEP adherence and limited trial evidence suggests integrated adherence interventions may improve biomarker outcomes.
The Friendship Bench (FB) model-an evidence-based, lay health worker-delivered problem-solving therapy program developed in Zimbabwe and adapted across low-resource settings-produces substantial reductions in depressive symptoms and can be delivered in person or digitally. FB's original form had limited effects on ART adherence, prompting calls to explicitly integrate adherence counseling; systematic adaptation is required to make FB effective for MSM by incorporating minority stress theory, addressing anti-MSM stigma and disclosure challenges, and adding explicit adherence skills training.
Aurum's POP INN clinics provide MSM-friendly services and peer support and have piloted FB-style coaching, revealing high rates of medication adherence challenges and moderate-to-severe depression among MSM. Pilot quantitative and qualitative data identify predictors of non-suppression and adherence problems-such as clinic location, transactional sex, missed doses, anxiety, and shorter ART duration-and show a clear preference among MSM for HIV status-neutral programming. Building on these findings, the proposed WeCare intervention aims to adapt Facebook into a status-neutral, minority-stress-informed package that integrates problem-solving therapy with explicit PrEP/ART adherence support, delivered by trained lay coaches, to improve mental health, medication adherence, viral suppression, stigma reduction, and community cohesion.
- Conditions
- HIV Infections, Mental Health
- Being tested
- WeCare, Standard of Care
- Keywords
- Men having sex with Men, Medication adherence, PrEP Adherence, ART Adherence
- Medical subject headings
- HIV Infections, Psychological Well-Being, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeCareBehavioural
The intervention is an adapted Friendship Bench (FB) for MSM in South Africa that integrates counseling on HIV medication adherence and the mental health-adherence relationship. The intervention includes up to 4 individual sessions and up to 4 group sessions; individual sessions may be delivered in person or online (Inuka-style), while all group sessions are in person.
Standard of CareBehavioural
The control group will receive enhanced standard care at POP INN Wellness Clinic: psychoeducation for all PrEP/ART enrollees, free medication, access to ongoing support groups, and referrals provided by the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Friendship Bench (FB) arm | Experimental | Not described Receives: Behavioral: WeCare |
| Control Arm | Other | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment : Modified version of the Session Evaluation Form (SEF) score
13-item SEF measuring perceived feasibility, acceptability, and intervention utility.
Composite scores are calculated with higher scores indicating more perceived feasibility and acceptability.
Measured: Baseline, Month 3, Month 6
Change in Client Satisfaction Survey (CSQ-8) score
8-item CSQ assessing satisfaction with recruitment, retention, and intervention procedures, engagement data from the trial (e.g., completion of sessions).
Composite scores are calculated with higher scores indicating more satisfaction.
Measured: Baseline, Month 3, Month 6
Mental health measures: Change in The Patient Health Questionnaire (PHQ-9) scores
The Patient Health Questionnaire (PHQ-9) measures the frequency of depression symptoms within the past two weeks. The PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms
Measured: Baseline, Month 3, Month 6
Change in Psychological stress: WHO Self-Reporting Questionnaire-20 (SRQ-20) score
The WHO Self-Reporting Questionnaire-20 (SRQ-20) includes items to reflect symptoms of depression, anxiety and psychosomatic complaints, which are all together grouped under the heading of common mental disorder (CMD) and have been found to detect probable mental health disorder with satisfactory accuracy
Measured: Baseline, Month 3, Month 6
Change in ART adherence
ART adherence will be defined as a suppressed HIV viral load (HIV-1 RNA viral load <200 copies/mL) in a blood sample
Measured: Baseline, Month 3, Month 6
Change in PrEP adherence
PrEP adherence will be defined as an intracellular Tenofovir Diphosphate (TFV-DP) concentration ≥700 fmol/punch in a dried blood spot (DBS) sample. This concentration was found consistent with an average of ≥4 doses/week in the prior month in a directly observed study among men and women in the United States
Measured: Baseline, Month 3, Month 6
Secondary outcomes (2)
Self reported medication adherence
Adherence outcomes will be based on self-report data, where participants will be asked, "How many days did you not take your PrEP in the past 30 days (0-30 days)
Measured: Baseline, Month 3, Month 6
Status neutral composite adherence
Based on Tenofovir Diphosphate (TFV-DP) concentration ≥700 fmol/punch OR HIV-1 RNA viral load <200 copies/ml
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Dec 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Don Operario, Emory University
- Investigators
- Don Operario, PhD, Principal investigator, Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226323
- Sponsor's protocol ID
- STUDY00009339
- Other IDs
- 5R34MH135806-02, 2025P010078
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with researchers who submit a methodologically sound proposal. Data will be collected by Aurum; Aurum will share de-identified data with Emory (including data dictionaries).
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa
- ClinicalTrials.gov ID
- NCT07226323
- Acronym / sponsor ID
- STUDY00009339
- Conditions
- HIV Infections, Mental Health
- Keywords
- Men having sex with Men, Medication adherence, PrEP Adherence, ART Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the WeCare intervention-an adapted Friendship Bench program that integrates problem-solving therapy, minority-stress-informed content, and explicit PrEP/ART adherence skills-improves mental health and HIV medication adherence among men who have sex with men (MSM). It will also assess the safety, acceptability, and feasibility of delivering WeCare through trained lay coaches in community clinics.
Main questions the trial aims to answer:
- Does WeCare reduce symptoms of depression and anxiety among MSM?
- Does WeCare improve PrEP and ART adherence and increase rates of viral suppression among participants on ART?
- Is WeCare acceptable, feasible, and safe when delivered by lay coaches in POP INN clinics compared with usual care?
Detailed description
Men who have sex with men (MSM) in sub-Saharan Africa face very high HIV incidence and prevalence, with South Africa carrying the largest national burden and an estimated ~30% HIV prevalence among MSM. National policies in South Africa endorse universal test-and-treat and prioritize MSM for Pre-Exposure Prophylaxis (PrEP) and Anti-Retroviral Therapy (ART), but care cascade indicators and adherence outcomes for MSM lag behind national averages, indicating a need for differentiated, targeted service approaches.
Common mental health problems are prevalent among MSM and are strongly associated with poorer PrEP and ART adherence. Randomized and quasi-experimental trials in the region show that lay-delivered or nurse-delivered mental health interventions can reduce depression and improve ART adherence and viral suppression, while observational studies link poor mental health to lower PrEP adherence and limited trial evidence suggests integrated adherence interventions may improve biomarker outcomes.
The Friendship Bench (FB) model-an evidence-based, lay health worker-delivered problem-solving therapy program developed in Zimbabwe and adapted across low-resource settings-produces substantial reductions in depressive symptoms and can be delivered in person or digitally. FB's original form had limited effects on ART adherence, prompting calls to explicitly integrate adherence counseling; systematic adaptation is required to make FB effective for MSM by incorporating minority stress theory, addressing anti-MSM stigma and disclosure challenges, and adding explicit adherence skills training.
Aurum's POP INN clinics provide MSM-friendly services and peer support and have piloted FB-style coaching, revealing high rates of medication adherence challenges and moderate-to-severe depression among MSM. Pilot quantitative and qualitative data identify predictors of non-suppression and adherence problems-such as clinic location, transactional sex, missed doses, anxiety, and shorter ART duration-and show a clear preference among MSM for HIV status-neutral programming. Building on these findings, the proposed WeCare intervention aims to adapt Facebook into a status-neutral, minority-stress-informed package that integrates problem-solving therapy with explicit PrEP/ART adherence support, delivered by trained lay coaches, to improve mental health, medication adherence, viral suppression, stigma reduction, and community cohesion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Friendship Bench (FB) arm | Experimental | Behavioral: WeCare |
| Control Arm | Other | Behavioral: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male
- reports sexual intercourse with a man in the past 6 months
- reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months
- ability to communicate in English
- current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic.
Key exclusion criteria (3 listed)
- Presently engaged in mental health therapy.
- Participated in qualitative phase of WeCare study (AUR2-18-419) or open-pilot (present study).
- Refuses audio recording of the in-person or online individual counselling session
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeCareThe intervention is an adapted Friendship Bench (FB) for MSM in South Africa that integrates counseling on HIV medication adherence and the mental health-adherence relationship. The intervention includes up to 4 individual sessions and up to 4 group sessions; individual sessions may be delivered in person or online (Inuka-style), while all group sessions are in person. | Behavioural | Friendship Bench (FB) arm |
| Standard of CareThe control group will receive enhanced standard care at POP INN Wellness Clinic: psychoeducation for all PrEP/ART enrollees, free medication, access to ongoing support groups, and referrals provided by the clinic. | Behavioural | Control Arm |
Primary outcome
Assessment : Modified version of the Session Evaluation Form (SEF) score
Time frame: Baseline, Month 3, Month 6
13-item SEF measuring perceived feasibility, acceptability, and intervention utility. Composite scores are calculated with higher scores indicating more perceived feasibility and acceptability.
Change in Client Satisfaction Survey (CSQ-8) score
Time frame: Baseline, Month 3, Month 6
8-item CSQ assessing satisfaction with recruitment, retention, and intervention procedures, engagement data from the trial (e.g., completion of sessions). Composite scores are calculated with higher scores indicating more satisfaction.
Mental health measures: Change in The Patient Health Questionnaire (PHQ-9) scores
Time frame: Baseline, Month 3, Month 6
The Patient Health Questionnaire (PHQ-9) measures the frequency of depression symptoms within the past two weeks. The PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms
Change in Psychological stress: WHO Self-Reporting Questionnaire-20 (SRQ-20) score
Time frame: Baseline, Month 3, Month 6
The WHO Self-Reporting Questionnaire-20 (SRQ-20) includes items to reflect symptoms of depression, anxiety and psychosomatic complaints, which are all together grouped under the heading of common mental disorder (CMD) and have been found to detect probable mental health disorder with satisfactory accuracy
Change in ART adherence
Time frame: Baseline, Month 3, Month 6
ART adherence will be defined as a suppressed HIV viral load (HIV-1 RNA viral load <200 copies/mL) in a blood sample
Change in PrEP adherence
Time frame: Baseline, Month 3, Month 6
PrEP adherence will be defined as an intracellular Tenofovir Diphosphate (TFV-DP) concentration ≥700 fmol/punch in a dried blood spot (DBS) sample. This concentration was found consistent with an average of ≥4 doses/week in the prior month in a directly observed study among men and women in the United States
2 secondary outcomes
Self reported medication adherence
Time frame: Baseline, Month 3, Month 6
Status neutral composite adherence
Time frame: Baseline, Month 3, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. Data will be shared with researchers who submit a methodologically sound proposal. Data will be collected by Aurum; Aurum will share de-identified data with Emory (including data dictionaries).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Don Operario, PhD principal investigator
Rollins School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeCare in people with HIV Infections and Mental Health, run by Emory University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Don Operario, PhD (404-727-0503, don.operario@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment : Modified version of the Session Evaluation Form (SEF) score (time frame: Baseline, Month 3, Month 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.