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

NCT05664490 | Completed Results DMC

• 2 other identifiers: 22-376804R00MH123369-03
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Pre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (2)

• PrEP Adherence at 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

  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 Outcomes (5)

• PrEP Adherence at Week 4

  Week 4

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

  Week 4

• Acceptability of Youth Friendship Bench SA

  12 Weeks

• Feasibility of Youth Friendship Bench SA

  12 Weeks

• Appropriateness of Youth Friendship Bench SA

  12 Weeks

Study Arms (2)

Standard-of-Care Mental Health Services

NO INTERVENTION

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.

Youth Friendship Bench SA + Standard-of-Care

EXPERIMENTAL

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

Interventions

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.

Youth Friendship Bench SA + Standard-of-Care

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

Wits Reproductive Health Institute

Johannesburg, Gauteng, South Africa

Location

Related Publications (6)

• Velloza J, Hosek S, Donnell D, Anderson PL, Chirenje M, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C; HPTN 082 study group. Assessing longitudinal patterns of depressive symptoms and the influence of symptom trajectories on HIV pre-exposure prophylaxis adherence among adolescent girls in the HPTN 082 randomized controlled trial. J Int AIDS Soc. 2021 Jun;24 Suppl 2(Suppl 2):e25731. doi: 10.1002/jia2.25731.

  PMID: 34164929 BACKGROUND

• Remien RH, Stirratt MJ, Nguyen N, Robbins RN, Pala AN, Mellins CA. Mental health and HIV/AIDS: the need for an integrated response. AIDS. 2019 Jul 15;33(9):1411-1420. doi: 10.1097/QAD.0000000000002227.

  PMID: 30950883 BACKGROUND

• Abas M, Nyamayaro P, Bere T, Saruchera E, Mothobi N, Simms V, Mangezi W, Macpherson K, Croome N, Magidson J, Makadzange A, Safren S, Chibanda D, O'Cleirigh C. Feasibility and Acceptability of a Task-Shifted Intervention to Enhance Adherence to HIV Medication and Improve Depression in People Living with HIV in Zimbabwe, a Low Income Country in Sub-Saharan Africa. AIDS Behav. 2018 Jan;22(1):86-101. doi: 10.1007/s10461-016-1659-4.

  PMID: 28063075 BACKGROUND

• Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102.

  PMID: 28027368 BACKGROUND

• Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, Gaynes BN, Mphonda SM, Mwagomba BM, Mazenga AC, Pence BW. Integrating depression management into HIV primary care in central Malawi: the implementation of a pilot capacity building program. BMC Health Serv Res. 2018 Jul 31;18(1):593. doi: 10.1186/s12913-018-3388-z.

  PMID: 30064418 BACKGROUND

• Brooks MJ, Phetogo BK, Schwennesen H, Phoi O, Tshume O, Matshaba M, Lowenthal E. Building a Community Based Mental Health Program for Adolescents in Botswana: Stakeholder Feedback. Community Ment Health J. 2022 Aug;58(6):1068-1075. doi: 10.1007/s10597-021-00915-5. Epub 2021 Nov 26.

  PMID: 34826035 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

This study was a pilot study with a small sample size and retention challenges. Retention was lower in the Youth Friendship Bench arm than Standard of Care Mental Health Services arm. We did not collect biomarker data on longer-term PrEP adherence given the short duration of follow-up.

Results Point of Contact

• Title: Dr. Jennifer Velloza
• Organization: University of California, San Francisco

Jennifer.Velloza@ucsf.edu

9173923561

Study Officials

• Jennifer Velloza, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: April 24, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: End of study.
• Access Criteria: Reasonable request to the Principal Investigator.

Locations

ZA (1)