Heads Angela M, Santa Maria Diane, Hill Mandy J, Suchting Robert, Evans Kimberly N, Gaul Zaneta, Yammine Luba, de Dios Constanza, Schmitz Joy M
McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, United States.
Cizik School of Nursing, University of Texas Health Science Center at Houston, Houston, TX, United States.
JMIR Res Protoc. 2025 May 23;14:e64961. doi: 10.2196/64961.
Black and Hispanic women in the United States continue to bear disproportionate incidence of HIV related to sexual transmission and injection drug use. Specifically, women with substance use disorders (SUDs) are more likely to engage in vaginal or anal condomless sex associated with HIV transmission. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool but is not widely used by racial or ethnic minority women. Effective interventions for engaging women with SUDs in HIV prevention interventions that are culturally appropriate and, therefore, more appealing to racial or ethnic minority women with SUDs are critically needed.
This 3-phased study, including a pilot randomized controlled trial (RCT), will assess the initial efficacy, feasibility, and acceptability of an addiction clinic-based behavioral and PrEP services intervention to increase the uptake and adherence to PrEP among racial or ethnic minority women.
A 3-phased mixed methods research design will involve formative qualitative methods using thematic analysis to design the intervention (phase 1), theatre testing to adapt and refine the intervention (phase 2), and RCT methods to pilot test the intervention for efficacy, feasibility, and acceptability (phase 3). The pilot RCT will enroll and randomize 60 women to either the standard SUD treatment program or SUD treatment integrated with PrEP services. The addiction clinic-based behavioral intervention will include 4 motivational counseling sessions guided by the Information-Motivation-Behavioral Skills Model to increase the uptake of PrEP. A mobile health app will be used to engage participants with the intention of motivating PrEP initiation and supporting adherence to PrEP. Following phase 3, generalized linear modeling will be used to model effects of the proportion of participants who fill their prescription and take at least 1 dose as a function of the intervention group.
Findings from individual qualitative interviews informed the development of the addiction clinic-based behavioral intervention. Study recruitment for the randomized pilot (phase 3) launched in May 2024. Additional statistical analyses will be performed upon completion of the study.
This addiction clinic-based behavioral intervention aims to increase PrEP uptake and adherence among racial or ethnic minority women who engage in sexual and substance use behaviors associated with increased susceptibility to HIV transmission. The addiction clinic-based behavioral intervention has the potential to reduce HIV-related disparities among Black and Hispanic women with SUDs. Findings from this study will provide a foundation for future HIV prevention interventions for racial or ethnic minority women with SUDs.
ClinicalTrials.gov NCT06158607; https://clinicaltrials.gov/study/NCT06158607?term=NCT06158607&rank=1.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/64961.
美国黑人女性和西班牙裔女性感染艾滋病毒的比例持续过高，这与性传播和注射吸毒有关。具体而言，患有物质使用障碍（SUD）的女性更有可能进行与艾滋病毒传播相关的无阴道或肛门避孕套性行为。暴露前预防（PrEP）是一种高效的艾滋病毒预防工具，但种族或少数族裔女性并未广泛使用。迫切需要有效的干预措施，使患有SUD的女性参与到适合其文化背景、因而对患有SUD的种族或少数族裔女性更具吸引力的艾滋病毒预防干预中。
这项分三个阶段的研究，包括一项试点随机对照试验（RCT），将评估基于成瘾诊所的行为和PrEP服务干预措施的初步疗效、可行性和可接受性，以提高种族或少数族裔女性对PrEP的接受率和依从性。
分三个阶段的混合方法研究设计将包括使用主题分析的形成性定性方法来设计干预措施（第一阶段）、进行剧场测试以调整和完善干预措施（第二阶段），以及采用RCT方法对干预措施进行试点测试，以评估其疗效、可行性和可接受性（第三阶段）。试点RCT将招募60名女性并将她们随机分为标准SUD治疗项目组或与PrEP服务相结合的SUD治疗组。基于成瘾诊所的行为干预将包括4次以信息-动机-行为技能模型为指导的动机咨询会议，以提高对PrEP的接受率。将使用一款移动健康应用程序来促使参与者开始使用PrEP并支持其坚持使用。在第三阶段之后，将使用广义线性模型来模拟作为干预组函数的填写处方并至少服用1剂的参与者比例的影响。
个体定性访谈的结果为基于成瘾诊所的行为干预的开发提供了依据。随机试点（第三阶段）的研究招募于2024年5月启动。研究完成后将进行额外的统计分析。
这种基于成瘾诊所的行为干预旨在提高参与与艾滋病毒传播易感性增加相关的性和物质使用行为的种族或少数族裔女性对PrEP的接受率和依从性。这种基于成瘾诊所的行为干预有可能减少患有SUD的黑人和西班牙裔女性之间与艾滋病毒相关的差异。这项研究的结果将为未来针对患有SUD的种族或少数族裔女性的艾滋病毒预防干预提供基础。
ClinicalTrials.gov NCT06158607；https://clinicaltrials.gov/study/NCT06158607?term=NCT06158607&rank=1。
国际注册报告识别码（IRRID）：DERR1-10.2196/64961。
