Skip to main content
OpenTrials
Completed

NCT Number: NCT05664490

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms Pre-exposure Prophylaxis

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wits Reproductive Health Institute

Johannesburg, Gauteng, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Youth Friendship Bench SA

Behavioral

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.

Primary outcomes

  1. PrEP Adherence at Week 12

    Time frame: Week 12

    The proportion of participants with PrEP adherence at Month 3, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay

  2. Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7

    Time frame: Baseline and Week 12

    The change in the proportion of participants with SRQ-20 scores <7 will be reported. Mental health symptoms will be measured on the SRQ-20, with a score below 7 indicating no or mild symptoms of depression, anxiety, or stress. SRQ-20 scores are calculated as the sum of responses across 20 items asking about symptoms of common mental disorders (e.g. depression, anxiety). Each item has a yes or no response and 'yes' responses are coded as '1' and 'no' responses are coded as '0' (possible score range = 0-20, with higher scores indicating greater severity of common mental disorder symptoms).

Secondary outcomes

  1. PrEP Adherence at Week 4

    Time frame: Week 4

    The proportion of participants with PrEP adherence at Week 4, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay

  2. Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7

    Time frame: Week 4

    The change in the proportion of participants with SRQ-20 scores <7 will be reported. Mental health symptoms will be measured on the SRQ-20, with a score below 7 indicating no or mild symptoms of depression, anxiety, or stress. SRQ-20 scores are calculated as the sum of responses across 20 items asking about symptoms of common mental disorders (e.g. depression, anxiety). Each item has a yes or no response and 'yes' responses are coded as '1' and 'no' responses are coded as '0' (possible score range = 0-20, with higher scores indicating greater severity of common mental disorder symptoms).

  3. Acceptability of Youth Friendship Bench SA

    Time frame: 12 Weeks

    Acceptability of the Youth Friendship Bench SA intervention as measured by the 4-item Acceptability of Intervention Measure (AIM). The AIM used in this study consists of 4 questions with scales values that range from 1 to 4. Higher scores indicate greater acceptability.

  4. Feasibility of Youth Friendship Bench SA

    Time frame: 12 Weeks

    Feasibility of the Youth Friendship Bench SA intervention as measured by the 4-item Feasibility of Intervention Measure (FIM). The FIM used in this study consists of 4 questions with scales values that range from 1 to 4. Higher scores indicate greater acceptability.

  5. Appropriateness of Youth Friendship Bench SA

    Time frame: 12 Weeks

    Appropriateness of the Youth Friendship Bench SA intervention as measured by the 4-item Intervention Appropriateness Measure (IAM). The IAM used in this study consists of 4 questions with scales values that range from 1 to 4. Higher scores indicate greater acceptability.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Witwatersrand, South Africa

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 23, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.