N/A
N=116
Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
Depression · Pre-Exposure Prophylaxis
Bottom Line
View on ClinicalTrials.gov: NCT05664490 ↗Enrolled (actual)
116
Serious AEs
1.7%
Results posted
Apr 2025
Primary outcome: Primary: PrEP Adherence at Week 12 — 29; 22 Participants — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Youth Friendship Bench SA (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PrEP Adherence at Week 12 |
29; 22 | 0.44 |
| PRIMARY Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 |
20; 15 | 0.37 |
| SECONDARY PrEP Adherence at Week 4 |
25; 29 | 0.03 sig |
| SECONDARY Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 |
20; 15 | 0.37 |
| SECONDARY Acceptability of Youth Friendship Bench SA |
3.5 | — |
| SECONDARY Feasibility of Youth Friendship Bench SA |
3.75 | — |
| SECONDARY Appropriateness of Youth Friendship Bench SA |
3.25 | — |
Summary
Adolescent girls and young women (AGYW) at risk of HIV in sub-Saharan Africa, frequently (20-50%) have symptoms of common mental disorders, including depression, anxiety, and stress. These symptoms are associated with suboptimal adherence to HIV pre-exposure prophylaxis (PrEP), a highly effective HIV prevention approach. In this project, the team seeks to address poor mental health and consequent impacts on PrEP adherence and among AGYW at risk of HIV by testing an evidence-based mental health intervention (the Youth Friendship Bench SA) adapted for PrEP delivery programs.
Eligibility Criteria
Inclusion Criteria
- Female 18-25 years of age at screening
- Documentation of symptoms of a common mental disorder, as evidenced by a score greater than or equal to 7 on the Self Reporting Questionnaire 20-item (SRQ-20)
- Willingness to enroll and be randomized to either the Youth Friendship Bench SA or standard-of-care mental health services
- Written informed consent (obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.
- Able to verbally communicate in one or more study languages to ensure participation in the counseling sessions (English, isiZulu)
- Taking PrEP at the Ward 21 clinic, as determined by clinic records. PrEP provision will be conducted by the clinic following National PrEP Guidelines and will not be part of study-specific procedures.
Exclusion Criteria
- Not on PrEP and/or not intending to use PrEP for the duration of the study
- Planning to relocate in the next three months
- Report of suicidal intent or self harm
- Active, unmanaged mental health disorders, including untreated or severe somatic symptoms and active psychiatric symptoms (e.g., hallucinations)
- Reactive or positive HIV test at enrollment (based on clinic records only; HIV testing will not be performed under this protocol)
Data sourced from ClinicalTrials.gov (NCT05664490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.