NCT05664490

Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings

Youth Friendship Bench SA: Optimization of the Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized hybrid implementation-effectiveness trial which will be conducted in a real-world healthcare setting. Eligible women who accept open-label daily oral PrEP (n=110) will be enrolled and randomized to either the Youth Friendship Bench SA intervention (plus standard-of-care mental health services as needed) or standard-of-care mental health services alone. Randomization will be conducted in a 1:1 ratio with randomly-sized blocks of ≤10. HIV-uninfected women ages 18-25 in Johannesburg, South Africa, who have symptoms of common mental disorders as evidenced by a score greater than or equal to 7 on the SRQ-20 will be eligible to enroll. The investigators hypothesize that the Youth Friendship Bench SA will significantly improve PrEP adherence and reduce symptoms of common mental disorders among AGYW at Month 3.

Conditions

• Depression
• Pre-Exposure Prophylaxis

Interventions

Type	Name	Description
BEHAVIORAL	Youth Friendship Bench SA	The intervention includes: 5 individual counseling sessions; one optional in-person or WhatsApp-based group counseling session; optional remote counseling sessions; and optional one-way SMS messages to provide reminders about upcoming visits. During the initial session, participants will meet with the trained counselor to discuss mental health challenges, identify problems in their life that affect their mental health and PrEP use, generate alternative solutions, make decisions about the alternatives, and collaboratively decide on a plan to implement the solutions. During follow-up counseling sessions, participants will discuss progress in implementing solutions to address the problems they identified in prior sessions with the lay counselor. They will also discuss any other mental health challenges and problems in their life that affect their mental health and PrEP use which they would like to address.

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-02-09
• Completion: 2024-02-09
• First posted: 2022-12-23
• Last updated: 2025-04-11
• Results posted: 2025-04-11

Locations

1 site across 1 country: South Africa