Youth Friendship Bench SA: Optimization of the Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- PrEP Adherence at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Standard-of-Care Mental Health Services
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
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.
干预措施: Youth Friendship Bench SA (Behavioral)
结局指标
主要结局
PrEP Adherence at Week 12
时间窗: 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
Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7
时间窗: Baseline and Week 12
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).
次要结局
- PrEP Adherence at Week 4(Week 4)
- Appropriateness of Youth Friendship Bench SA(12 Weeks)
- 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)