Trauma-Informed HIV Prevention for Black Women in Baltimore
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- PrEP initiation
研究概览
简要总结
U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •self-identified Black cisgender woman;
- •self-reported HIV-negative status, and
- •≥18 years.
- •reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner,
- •have at least one substantial HIV risk factor in the past 6 months according to the 2021 Centers for Disease Control (CDC) PrEP Eligibility Guidelines (i.e., HIV-positive sexual partner, recent bacterial Sexually Transmitted Disease (STD), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high HIV prevalence area or network), and
- •never taken PrEP
排除标准
- •non-English speaking and
- •currently living with HIV
结局指标
主要结局
PrEP initiation
时间窗: Post baseline up to 6 months
Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.
次要结局
- PrEP adherence(2-months post-randomization, 4-months post-randomization, and 6-months post-randomization)