Integrated PrEP and ART Delivered in Ugandan Public Health Clinics to Improve HIV and ART Outcomes for HIV Serodiscordant Couples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,381
- 试验地点
- 1
- 主要终点
- Number of HIV-positive members of a discordant partnership who initiate ART
研究概览
简要总结
Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 HIV serodiscordant couples. Additionally, the program will collect qualitative and quantitative data to determine if PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART strategy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •For both members of the couple
- •Age ≥18 years
- •Able and willing to provide informed consent
- •Sexually active with each other
- •Willing to engage with the clinic system as a couple
- •For HIV-positive members of the couples (index participants)
- •HIV-positive, according to national HIV testing algorithm
- •Recent diagnosis as a member in an HIV serodiscordant couple
- •Not currently enrolled in an HIV treatment clinical trial
- •For HIV-negative members of the couples (partner participants)
- •HIV-negative, according to national HIV testing algorithm
- •Recent diagnosis as a member in an HIV serodiscordant couple
- •Not currently enrolled in an HIV treatment clinical trial
- •Not currently using PrEP
- •Eligible for PrEP, according to WHO or Ugandan national guidelines
排除标准
- •Otherwise not eligible based on the above inclusion criteria
研究组 & 干预措施
HIV serodiscordant couples
干预措施: PrEP (Drug)
HIV serodiscordant couples
干预措施: ART (Drug)
结局指标
主要结局
Number of HIV-positive members of a discordant partnership who initiate ART
时间窗: Up to 24 months
Measure ART initiation of the HIV-positive member of the couple
HIV viral load suppression of HIV-positive members of a discordant partnership
时间窗: Up to 24 months
ART adherence by measuring HIV viral load of the HIV-positive member of the couple
Number of HIV-negative members of a discordant partnership who initiate PrEP
时间窗: Up to 24 months
Measure PrEP initiation of the HIV-negative member of the couple
PrEP adherence of HIV-negative members of a discordant partnership
时间窗: Up to 24 months
Measure PrEP adherence, among HIV-negative members of a discordant partnership who initiated PrEP, by self-report and tenofovir drug level testing.
次要结局
- PrEP-taking as a modeled behavior(Up to 24 months)
- Facilitators and barriers to use of ART and PrEP(Up to 24 months)
- Programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples(Up to 24 months)
研究者
Renee Heffron
Assistant Professor, School of Public Health: Global Health
University of Washington