IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 4
- 主要终点
- Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots
研究概览
简要总结
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
详细描述
Study Design:
This is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP.
Primary objectives:
- Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas.
- Assess feasibility of Truvada procurement through the established Gilead access program
- Evaluate adherence at week 12 and week 24 using dried blood spots
Secondary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 - 64 years old
- •Able to give consent
- •"At risk" for HIV as defined by any of the following:
- •unprotected sex (in past 6 months) with 1 or more men of unknown HIV status
- •evaluated for an STI within 6 months prior to screening
- •sex in last 6 months with an HIV-infected partner
- •IDU with report of using previously used or shared needles in past 6 months or has been in a methadone, buprenorphine, or suboxone treatment program in past 6 months or engaging in high-risk sexual behaviors
- •individuals engaging in transactional sex (i.e sex for money, drugs, or housing)
- •Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IDU or bisexual male partner)
- •CrCl ≥ 60 ml/min
- •HIV- uninfected women desiring PrEP
排除标准
- •Active alcohol or drug use or dependence which may interfere with adherence to study requirements
- •HIV-infected at screening or enrollment
- •Estimated CrCl < 60 mL/min
- •Past participation in an HIV vaccine study
- •Positive Hepatitis B surface antigen test
- •Underlying medical condition with survival unlikely during follow-up period
- •Any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives
- •Pregnant or breast feeding
- •Actively trying to achieve pregnancy
研究组 & 干预措施
PrEP with Truvada
All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP
干预措施: tenofovir disoproxil and emtricitabine (Drug)
结局指标
主要结局
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots
时间窗: 24 Weeks
Dried blood spot tenofovir-diphosphate levels were summarized using prespecified adherence threshold categories at week 12 and week 24.
PrEP Awareness and Interest Questionnaire Responses at Week 24
时间窗: 24 weeks
Assessment of participants' attitudes toward pre-exposure prophylaxis using questionnaires
次要结局
- Feasibility of Obtaining Truvada Via the Gilead Access Program(24 Weeks)
研究者
Shobha Swaminathan
Professor
Rutgers, The State University of New Jersey