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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Pre-Exposure Prophylaxis

Intervention / Treatment
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* Behavioral: Youth Friendship Bench SA


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard-of-Care Mental Health Services<br>Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. | |
| Experimental: Youth Friendship Bench SA + Standard-of-Care<br>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. | Behavioral: Youth Friendship Bench SA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP adherence at Week 12 | proportion with PrEP adherence at Month 3, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay | Week 12 | 
| Change in Proportion of Participants with Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | 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). | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP adherence at Week 4 | proportion with PrEP adherence at Week 4, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay | Week 4 |