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

Not Applicable

Completed

Conditions: Depression
Pre-Exposure Prophylaxis

Interventions: Behavioral: Youth Friendship Bench SA

Registration Number: NCT05664490

Lead Sponsor: University of California, San Francisco

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 116

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Youth Friendship Bench SA + Standard-of-Care	Youth Friendship Bench SA	Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines.

Primary Outcome Measures

Name	Time	Method
PrEP Adherence at Week 12	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
Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7	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 Outcome Measures

Name	Time	Method
PrEP Adherence at Week 4	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
Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7	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).
Acceptability of Youth Friendship Bench SA	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.
Feasibility of Youth Friendship Bench SA	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.
Appropriateness of Youth Friendship Bench SA	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.