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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Pre-Exposure Prophylaxis; Depression

Treatments: Behavioral: Youth Friendship Bench SA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05664490

4R00MH123369-03 (U.S. NIH Grant/Contract)

22-37680

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Standard-of-Care Mental Health Services

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Youth Friendship Bench SA