Targeted Interventions to Address the Multi-level Effects of Gender-based Violence on PrEP Uptake and Adherence Among Adolescent Girls and Young Women in Siaya County, Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Intervention safety - survey tool
研究概览
简要总结
This study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and Safe) initiative in Siaya County, Kenya. It will test a pilot intervention that will address barriers to pre-exposure prophylaxis (PrEP) uptake and adherence in adolescent girls and young women (AGYW) to reduce their risk to HIV acquisition, with a focus on barriers stemming from male partners and gender-based violence.
详细描述
This study is designed to assess feasibility, safety, and preliminary effects of a behavioral intervention aimed at increasing pre-exposure prophylaxis (PrEP) uptake and adherence in adolescent girls and young women (AGYW), with a focus on barriers stemming from male partners and gender-based violence, through a pilot cluster randomized-controlled trial (RCT). This study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and Safe) initiative in Siaya County, Kenya. Six DREAMS Safe Spaces and their catchment areas will be randomized to receive this community-level intervention or standard of care. Primary outcomes will include feasibility (recruitment, retention) and safety (ongoing or renewed experience of GBV). The investigators will also determine whether the intervention shows promise in increasing PrEP uptake, adherence, and persistence at 6 months. After the intervention, small group discussions, in-depth interviews with male partners, and provider questionnaires will explore acceptability and effects on PrEP decision making and use.
Population: AGYW ages 15-24 enrolled in the DREAMS Initiative in Siaya County, Kenya, and, for in-depth interviews only, a subset of male partners of DREAMS participants.
Objectives: The goal of this work is to test the feasibility, acceptability, safety, and preliminary effects of the intervention on PrEP uptake and adherence among AGYW.
The primary objectives are to assess:
- Intervention safety
- Feasibility of delivering the intervention within DREAMS operations
- Acceptability of the intervention to participants, staff, and male partners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 15-24 years (inclusive);
- •HIV-negative, by self-report;
- •At high risk for acquiring HIV, as defined by the 2016 Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infections in Kenya;
- •Fluent in English, Dholuo, or Swahili;
- •Enrolled in DREAMS (defined by having a DREAMS identification (ID) number);
- •Lives within the Safe Space catchment area - 7) Willing and able to attend support groups over the 6-month period;
- •Potentially interested in PrEP and/or using PrEP already;
- •Able and willing to provide adequate locator information, as defined in site standard operating procedures (SOPs);
- •If aged 18 and above: Willing and able to provide informed consent;
- •If non-mature minor aged 15-17: Willing and able to provide assent and parent or guardian willing and able to provide parental consent;
- •If mature minor aged 15-17: Willing and able to provide informed consent or to provide assent and parent or guardian consent, per participant choice.
排除标准
- •Planning to relocate away from the study catchment area in the next 6 months;
- •Planning to travel away from the study catchment area for a time period that would interfere with study participation; or
- •Has any condition that, in the opinion of the site PI, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
结局指标
主要结局
Intervention safety - survey tool
时间窗: 6 months
Self-report of experience of social harms in the past 3 months and violence or controlling behavior using an adapted version of the World Health Organization's questions on violence against women. Behaviors are reported for every experience in the past 3 months and frequency of experience (e.g., once, few times, many times).
Intervention safety - form
时间窗: Throughout the study, approximately 6 months
Reports of new or ongoing gender-based violence (GBV), social harms, serious adverse events, or unanticipated problems during study participation. Information will be self-reported using an specially-developed form
Feasibility of the behavioral intervention - Process Indicators
时间窗: Throughout the study, approximately 6 months
Measures of feasibility including recruitment timelines and numbers enrolled, retention rates, intervention participation measured by attendance at support club sessions and other intervention activities, and fidelity of intervention delivery measured through documented observations of intervention delivery capturing activities administered and ratings of quality.
Acceptability of the behavioral intervention - qualitative data from participants
时间窗: 6 months
Acceptability measures include qualitative reports of intervention acceptability among participants. These will include in-depth interviews covering topics such as satisfaction with content, delivery, and length of the intervention, as well as reported impact on the participant's life.
Acceptability of the behavioral intervention - quantitative data from participants
时间窗: 6 months
Quantitative reports of intervention acceptability among participants. Satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options.
Acceptability of the behavioral intervention - quantitative data from providers
时间窗: 6 months
Satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options.
Acceptability of the behavioral intervention - qualitative data from male partners
时间窗: 6 months
Qualitative reports of intervention acceptability among male partners. These will include in-depth interviews covering topics such as satisfaction with content, delivery, and length of the intervention, as well as reported impact on the male partner's life.
次要结局
- Pre-Exposure Prophylaxis (PrEP) uptake(6 months)
- Proportion of participants with Pre-Exposure Prophylaxis (PrEP) adherence > 85% at six months(Throughout the study, approximately 6 months)
- Pre-Exposure Prophylaxis (PrEP) persistence among participants at six months(6 months)