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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH135806 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Condition | Active Comparator | The control group (Phase 3) will receive enhanced standard care which includes access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, enrollment in their standard drop-in Mpowerment support groups, as well as referrals to mental health services on request |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WeCare | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence (ART) | ART adherence will be defined as a suppressed HIV viral load (HIV-1 RNA viral load <200 copies/mL) in the blood sample | Baseline, Month 3, Month 6 |
| Medication adherence (PrEP) | PrEP adherence is defined as an intracellular TFV-DP concentration ≥700 fmol/punch in a dried blood spot (DBS) sample | Baseline, Month 3, Month 6 |
| 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. | Baseline, Month 3, Month 6 |
| 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). | Baseline, Month 3, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Status neutral composite adherence | This is based on TFV-DP concentration ≥700 fmol/punch in a dried blood spot (DBS) sample OR HIV-1 RNA viral load <200 copies/mL) | Baseline, Month 3, Month 6 |
| Self Reported medication adherence |
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Inclusion Criteria:
Exclusion Criteria:
cis-gender male (assigned male at birth and identify as male)
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Pienaar | The Aurum Institute, Johannesburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Aurum Institute | Johannesburg | 2194 | South Africa |
individual participant data that underlie the results reported in this article will be shared after deidentification (text, tables, figures, and appendices).
Immediately following publication (anticipated June 2026)
Proposals should be directed to don.operario@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2024 | Mar 6, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Behavioral | Access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, and enrollment in their standard drop-in. Mpowerment support groups, as well as referrals to mental health services on request |
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participants will be asked, "How many days did you not take your PrEP [ART] in the past 30 days (0-30 days)
| Baseline, Month 3, Month 6 |
| Persistence | Defined as time to first PrEP discontinuation, based on a PrEP clinical hold, elective PrEP stop, or missed prescription refill as indicated by pharmacy data | Baseline, 3 months, 6 months |