HIVNCT06880172
Mental Health and Medication Adherence Among MSM in South Africa
A study testing WeCare in people with HIV, run by Emory University at 1 site in South Africa.
Trial summary
The goal of this behavioral study is to improve psychological well-being and optimization of HIV prevention and care outcomes for Men who have sex with men (MSM) in South Africa. 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
- 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
- 12 participants
- Where
- 1 siteSouth Africa
- Study dates
- 26 May 2025to 23 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cis-gender male
- Reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months
- Current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic
- Self-reported challenges adhering to daily ART (HIV-positive participants) or PrEP (HIV-negative participants)
- Interested in participating in a group discussion to discuss common mental health problems and medication adherence challenges
- Ability to understand and provide informed consent.
Who cannot join
- Presently engaged in mental health therapy.
- Participated as an intervention participant in a pilot mental health study (AUR6-8-403)
- Refuses audio recording of the focus group discussion
- Those who score over 20 on the PHQ-9 (i.e., indicating severe depression)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Mental Health and Medication Adherence Among MSM in South Africa
The goal of this behavioral study is to improve psychological well-being and optimization of HIV prevention and care outcomes for Men who have sex with men (MSM) in South Africa.
Read the detailed description
Men who have sex with men (MSM) are at an increased risk of HIV infection and transmission, and MSM with depression or anxiety may have adherence to medication challenges. Development of an integrated mental health and adherence support intervention for MSM can be an effective strategy to improve both psychological outcomes and care continuum outcomes including adherence to Pre-Exposure prophylaxis (PrEP) and Anti Retroviral Therapy (ART).
The team proposes developing an intervention approach that responds to the unique social contexts of South African MSM living with or at risk for HIV, and that addresses the relationship between mental health and adherence to HIV prevention medication (daily PrEP) and ART. This intervention approach, WeCare, will adapt an evidence-based program entitled Friendship Bench (i.e., FB) - an empirically supported mental health program using problem-solving therapy (developed/validated in southern Africa) - to incorporate mental health and medication adherence concerns for MSM.
- Conditions
- HIV
- Being tested
- WeCare
- Keywords
- MSM, PrEP, ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeCareBehavioural
Individual level: Problem identification, Linking Mental health and minority stress, medication adherence, developing an action plan, complementing the plan, and follow-up.
Group level: Social support and self acceptance in MSM, coping with stigma and minority stress, support for medication adherence
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | The intervention involves four weekly individual sessions followed by four weekly group support sessions, focusing on themes from the individual sessions. Services will be provided by peer wellness coaches from the MSM community, who will undergo an intensive two-week training with role-play and feedback, followed by weekly supervision. All testing and treatment services are provided free through Aurum. Receives: Behavioral: WeCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Status
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, upto 2 months (+/- 2 weeks)
Psychological Stress
The WHO Self-Reporting Questionnaire-20 (SRQ-20) will be used that includes items to reflect symptoms of depression, anxiety and psychosomatic complaints, which are all together grouped under the heading of common mental disorder (CMD).
The SRQ-20 is a 20-item self-report screening instrument assessing symptoms of common mental disorders. Each item is scored as Yes (1) or No (0), with total scores ranging from 0 to 20. Higher scores indicate greater psychological distress.
Measured: Baseline, upto 2 months (+/- 2 weeks)
Secondary outcomes (1)
Self Reported Medication Adherence
Participants were asked, "How many days did you not take your PrEP [ART] in the past 30 days (0-30 days)
Measured: Baseline, upto 2 months (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start26 May 2025
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- Jacqueline Pienaar, Principal investigator, The Aurum Institute, Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880172
- Sponsor's protocol ID
- STUDY00007894
- Other IDs
- R34MH135806, IRB (Aim 2), IRB (Aim 2)
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2025
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data that underlie the results reported in this article will be shared after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Mental Health and Medication Adherence Among MSM in South Africa
- ClinicalTrials.gov ID
- NCT06880172
- Acronym / sponsor ID
- STUDY00007894
- Conditions
- HIV
- Keywords
- MSM, PrEP, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 May 2025 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Posted 8 Oct 2026
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 behavioral study is to improve psychological well-being and optimization of HIV prevention and care outcomes for Men who have sex with men (MSM) in South Africa.
Detailed description
Men who have sex with men (MSM) are at an increased risk of HIV infection and transmission, and MSM with depression or anxiety may have adherence to medication challenges. Development of an integrated mental health and adherence support intervention for MSM can be an effective strategy to improve both psychological outcomes and care continuum outcomes including adherence to Pre-Exposure prophylaxis (PrEP) and Anti Retroviral Therapy (ART).
The team proposes developing an intervention approach that responds to the unique social contexts of South African MSM living with or at risk for HIV, and that addresses the relationship between mental health and adherence to HIV prevention medication (daily PrEP) and ART. This intervention approach, WeCare, will adapt an evidence-based program entitled Friendship Bench (i.e., FB) - an empirically supported mental health program using problem-solving therapy (developed/validated in southern Africa) - to incorporate mental health and medication adherence concerns for MSM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: WeCareThe intervention involves four weekly individual sessions followed by four weekly group support sessions, focusing on themes from the individual sessions. Services will be provided by peer wellness coaches from the MSM community, who will undergo an intensive two-week training with role-play and feedback, followed by weekly supervision. All testing and treatment services are provided free through Aurum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cis-gender male
- Reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months
- Current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic
- Self-reported challenges adhering to daily ART (HIV-positive participants) or PrEP (HIV-negative participants)
- Interested in participating in a group discussion to discuss common mental health problems and medication adherence challenges
Key exclusion criteria (4 listed)
- Presently engaged in mental health therapy.
- Participated as an intervention participant in a pilot mental health study (AUR6-8-403)
- Refuses audio recording of the focus group discussion
- Those who score over 20 on the PHQ-9 (i.e., indicating severe depression)
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 |
|---|---|---|
| WeCareIndividual level: Problem identification, Linking Mental health and minority stress, medication adherence, developing an action plan, complementing the plan, and follow-up. Group level: Social support and self acceptance in MSM, coping with stigma and minority stress, support for medication adherence | Behavioural | Intervention Condition |
Primary outcome
Mental Health Status
Time frame: Baseline, upto 2 months (+/- 2 weeks)
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.
Psychological Stress
Time frame: Baseline, upto 2 months (+/- 2 weeks)
The WHO Self-Reporting Questionnaire-20 (SRQ-20) will be used that includes items to reflect symptoms of depression, anxiety and psychosomatic complaints, which are all together grouped under the heading of common mental disorder (CMD). The SRQ-20 is a 20-item self-report screening instrument assessing symptoms of common mental disorders. Each item is scored as Yes (1) or No (0), with total scores ranging from 0 to 20. Higher scores indicate greater psychological distress.
1 secondary outcome
Self Reported Medication Adherence
Time frame: Baseline, upto 2 months (+/- 2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. individual participant data that underlie the results reported in this article will be shared after deidentification (text, tables, figures, and appendices).
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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. This study is not recruiting at the moment.
Jacqueline Pienaar principal investigator
The Aurum Institute, Johannesburg
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, 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 8 Oct 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?
Yes. Results are posted in the registry (first posted 8 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Status (time frame: Baseline, upto 2 months (+/- 2 weeks)). The study lists 2 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 8 Oct 2026.