Clinical trial NCT05664490: Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Pre-Exposure Prophylaxis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Witwatersrand, South Africa
First posted: 2022-12-23
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: PrEP Adherence at Week 12
timeFrame: Week 12
measure: Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: PrEP Adherence at Week 4
timeFrame: Week 4
measure: Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7
timeFrame: Week 4
measure: Acceptability of Youth Friendship Bench SA
timeFrame: 12 Weeks
measure: Feasibility of Youth Friendship Bench SA
timeFrame: 12 Weeks
measure: Appropriateness of Youth Friendship Bench SA
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health Institute
state: Gauteng
Study officials:
affiliation: University of California, San Francisco
name: Jennifer Velloza, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.