HIV Self-Testing to Improve the Efficiency of PrEP Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 790
- 试验地点
- 1
- 主要终点
- HIV-1 Testing
研究概览
简要总结
In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.
详细描述
Guidelines recommend HIV-1 testing quarterly for individuals on PrEP. Clinic-based HIV testing every three months is costly for both clinics and participants. The investigators propose using HIV self-testing to replace quarterly clinic-based HIV testing for participants on PrEP, eliminating half of clinic visits and saving staffing and participant costs. The investigators want to understand the effect that reduced clinic contact frequency (resulting from HIV self-testing) has on PrEP adherence or completion of HIV-1 testing, overall and in subgroups.
The investigators will enroll roughly 495 eligible individuals on PrEP: 165 men and 165 women in HIV-1 serodiscordant couples and 165 women at risk of HIV-1 infection (priority populations for PrEP delivery in Kenya and more generally in Africa).
In this study, participants will be randomly assigned in a 2:1 fashion to either six-monthly clinic visits or quarterly clinic visits. Participants randomized to six-monthly clinic visits will receive a 6-month supply of PrEP and either two blood-based HIV self-tests (blood-based HIV self-testing arm) or two oral fluid HIV self-tests (oral fluid HIV self-testing arm). Participants randomized to quarterly clinic visits will receive a 3-month supply of PrEP and get tested for HIV by a healthcare professional at the clinic (standard of care arm)
Study outcomes, measured at Months 6 and 12, include PrEP adherence (defined as the detection of PrEP in dried blood spots as well as persistence in refilling PrEP), HIV-1 testing, and safety (including side effects and social harm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years HIV-1 uninfected based on negative HIV-1 rapid testing
- •Not currently enrolled in an HIV-1 prevention clinical trial
- •Taking PrEP and planning to continue
- •Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self-testing
- •Note: Women who are pregnant at screening/enrollment are still eligible
排除标准
- •Unable to provide written informed consent
- •Contraindication to use Tenofovir (TDF)+/- Emtricitabine (FTC)/ Lamivudine (3TC)
- •For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled for a single visit at baseline, if:
- •Able and willing to provide written informed consent
结局指标
主要结局
HIV-1 Testing
时间窗: Month 6
Self-reported HIV-1 testing in the past 6 months
Persistence in Refilling PrEP
时间窗: Month 6
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Number of Participants With Adherence to PrEP at 6 Months
时间窗: Month 6
Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.
次要结局
- HIV-1 Testing(Month 12)
- PrEP Adherence(Month 12)
- Persistence in Refilling PrEP(Month 12)
研究者
Jared Baeten
Professor, School of Medicine: Global Health; Dept. of Medicine, Allergy & Infectious Diseases
University of Washington