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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664490
• Other study ID #: 22-37680
• Secondary ID: 4R00MH123369-03
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: February 2025

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Jennifer Velloza, PhD, MPH
• Phone: 9173923561
• Email: jennifer.velloza[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Pre-Exposure Prophylaxis

Intervention

Behavioral:
• Youth Friendship Bench SA
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.

Locations

Country	Name	City	State
South Africa	Wits Reproductive Health Institute	Johannesburg	Gauteng

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH), University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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