跳至主要内容
临床试验/NCT06703060
NCT06703060
招募中
不适用

Trauma-Informed HIV Prevention for Black Women in Baltimore

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 300 人2025年2月28日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
HIV Prevention
发起方
Johns Hopkins Bloomberg School of Public Health
入组人数
300
试验地点
1
主要终点
PrEP initiation
状态
招募中
最后更新
上个月

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.

注册库
clinicaltrials.gov
开始日期
2025年2月28日
结束日期
2028年2月1日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

入排标准

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)

研究点 (1)

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