Adapting the 'Comprehensive Adherence Resource and Empowerment Support' Intervention for Multiple PrEP Methods Among Adolescent Girls and Young Women in South Africa and Zimbabwe
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,100
- 试验地点
- 2
- 主要终点
- Percentage of AGYW receiving on-time PrEP resupply [PrEP continuation]
研究概览
简要总结
The primary aim of this study is to adapt the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to support adolescent girls and young women (AGYW) aged 16-24 in Zimbabwe and South Africa in effectively using various forms of pre-exposure prophylaxis (PrEP), specifically oral, ring, and injectable PrEP. Originally developed for a clinical trial setting, CARES has shown promising results in enhancing effective PrEP use through a structured mix of counseling, SMS/phone calls, and peer support for daily oral PrEP and the PrEP ring. However, its resource-intensive design requires adaptation for routine public health settings to ensure feasibility, fidelity, acceptability, and effectiveness. This adapted intervention will be tailored with input from AGYW, PrEP providers, and local stakeholders to support sustainable PrEP use and address HIV prevention needs among AGYW. Additionally, it will incorporate injectable PrEP and be modified to suit routine public health contexts. Once the components are finalized, the adapted CARES intervention will be evaluated for effectiveness, feasibility, fidelity, and acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion (AGYW):
- •age 16-24 years (in Zimbabwe, participants aged 16 to 17 years must meet the legal criteria for emancipation to be eligible)
- •has initiated PrEP during the study, or no more than 6 months before the study initiation date (for LEN PrEP), or no more than 3 months before the study initiation date (for oral, ring, or CAB PrEP), and
- •willing and able to provide written informed consent for access to medical records, or assent and parental consent if applicable
- •fluent in one of the study languages (English, isiXhosa, Shona, Ndebele)
- •target date for PrEP resupply (i.e., to ensure continued coverage) falls within the month.
排除标准
- 未提供
研究组 & 干预措施
Comprehensive Adherence Resource and Empowerment Support (CARES)
Each health facility will initially offer standard of care (SOC) adherence counseling, then will transition on a randomly assigned start date to offering the CARES intervention instead of SOC adherence counseling. Choice of available PrEP methods will be available throughout the study as part of standard of care at the health facilities.
干预措施: Comprehensive Adherence Resource and Empowerment Support' (CARES) (Behavioral)
结局指标
主要结局
Percentage of AGYW receiving on-time PrEP resupply [PrEP continuation]
时间窗: Monthly for 27 months from the start of the pre-intervention period to the end of the intervention delivery period.
Percent of AGYW per clinic per month who have received on-time PrEP resupply at all scheduled visits for 3 months after initiation for CAB injection, oral PrEP, and ring or 6 months after initiation for LEN injection. Measured among those due for resupply visit in that month. On-time resupply is defined as resupply within a 14-day window of the target date to ensure continuous coverage.
次要结局
- Percentage of participants with high PrEP adherence [High PrEP adherence](Monthly for a total of 21 months, from the start of the pre-intervention period to the end of the intervention delivery period with a pause during the 6-month washout period after the start of intervention delivery.)
研究者
Sarah Roberts
Senior Research Epidemiologist
RTI International