NCT06158607招募中不适用
Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- PrEP uptake
研究概览
简要总结
The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is:
• If the integrated intervention increase PrEP uptake and adherence compared to standard treatment
Participants will
- receive provision of PrEP information through 4 counseling sessions
- prevention navigation
- receive nurse practitioner prescribed PrEP in an addiction treatment setting
Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Black/African American and Hispanic/Latina cisgender women
- •diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
- •HIV negative
- •sexually active with an opposite sex partner within the past 6 months
- •not using PrEP for HIV prevention at the time of screening
- •able to speak, read, and write in English; and
- •own or have regular access to a smart phone.
排除标准
- •be concurrently participating in another SUD behavioral treatment program
- •unable to provide informed consent for participation (e.g., have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy
- •have psychological distress that would prohibit them from participating in the study
- •be unable or unwilling to meet study requirements
- •be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
- •have medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use).
结局指标
主要结局
PrEP uptake
时间窗: 12 weeks post intervention
Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider
次要结局
- Daily PrEP adherence as assessed by the proportion of videos uploaded(12 weeks post PrEP initiation)
- Study retention as assessed by the number of participants that completed the study(12 weeks post enrollment)
- Intervention acceptability as assessed by the Client satisfaction questionnaire(12 weeks post intervention)
- Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations(90 days post PrEP initiation)
- Daily PrEP adherence as assessed by the proportion of self reported daily adherence(12 weeks post PrEP initiation)
- Enrollment rate as assessed by the number of participants that signed the consent form(12 weeks post intervention)
- Number of sessions attended by participants(12 weeks post enrollment)
研究者
Angela M Heads
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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