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

Last updated: March 24, 2025
Sponsor: University of California, San Francisco
Overall Status: Completed

Phase

N/A

Condition

Depression

Treatment

Youth Friendship Bench SA

Clinical Study ID

NCT05664490
22-37680
4R00MH123369-03
  • Ages 18-25
  • Female

Study 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

Inclusion Criteria:

  • Female 18-25 years of age at screening

  • Documentation of symptoms of a common mental disorder, as evidenced by a scoregreater 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 orstandard-of-care mental health services

  • Written informed consent (obtained from participant or participant's legalrepresentative and ability for participant to comply with the requirements of thestudy.

  • Able to verbally communicate in one or more study languages to ensure participationin the counseling sessions (English, isiZulu)

  • Taking PrEP at the Ward 21 clinic, as determined by clinic records. PrEP provisionwill be conducted by the clinic following National PrEP Guidelines and will not bepart of study-specific procedures.

Exclusion

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 somaticsymptoms and active psychiatric symptoms (e.g., hallucinations)

  • Reactive or positive HIV test at enrollment (based on clinic records only; HIVtesting will not be performed under this protocol)

Study Design

Total Participants: 116
Treatment Group(s): 1
Primary Treatment: Youth Friendship Bench SA
Phase:
Study Start date:
April 24, 2023
Estimated Completion Date:
February 09, 2024

Study 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.

Connect with a study center

  • Wits Reproductive Health Institute

    Johannesburg, Gauteng
    South Africa

    Site Not Available

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