Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change over time to adherence to PrEP using plasma
研究概览
简要总结
The purpose of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed intervention for tenofovir/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) engagement among street-based female sex workers (FSW) in Baltimore, Maryland.
详细描述
This study is a prospective two-group trial comparing the efficacy of a comprehensive PrEP adherence program compared to PrEP standard of care among FSW. Outcomes will be assessed through self-reported PrEP adherence as well as biological adherence indicators.
The intervention includes three main components: 1) group PrEP engagement sessions, which include four educational sessions that situate PrEP in a broader framework of access and barriers to care, provider/patient communication, sexual health, HIV/sexually transmitted infection (STI) education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the SPARC nurse practitioner and other providers; and 3) an mHealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Assigned female at birth and identify as a woman
- •Traded sex for money or drugs at least three times in the past three months
- •HIV negative
- •Willing to initiate PrEP
- •Not knowingly pregnant or planning to become pregnant during the following 6 months.
排除标准
- •Currently taking PrEP for HIV prevention
- •Inability to provide informed consent in English
- •Women who are determined as too high or drunk
- •Women who are cognitively impaired
- •Does not agree to data sharing with the Baltimore City Health Department
结局指标
主要结局
Change over time to adherence to PrEP using plasma
时间窗: 3 and 6 months
Adherence as the biological outcome, measured by the use of plasma to see concentration of tenofovir (ng/mL), to examine the pilot study's impact on adherence and inform metrics and outcomes of a future R01.
Change over time to adherence to PrEP using dried blood spots
时间窗: 3 and 6 months
Adherence as the biological outcome, measured by the use of dried blood spots to see concentration of tenofovir (fmol/punch), to examine the pilot study's impact on adherence and inform metrics and outcomes of a future R01.
次要结局
- Behavioral outcomes change over time(3 and 6 months)
- Structural vulnerabilities change over time(3 and 6 months)
- Individual PrEP change over time(weekly, from baseline visit to last study visit (six months from baseline))
- Individual health change over time(3 and 6 months)
- Social outcomes change over time(3 and 6 months)