Integrating HIV Prevention With TB Household Contact Evaluation in Uganda (TB PrEP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,480
- 试验地点
- 2
- 主要终点
- PrEP uptake
研究概览
简要总结
This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care (modified SOC) household TB contact investigation in Uganda. It uses qualitative methods to evaluate the process of implementing the intervention and a health economic evaluation to assess the financial sustainability of this strategy.
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Person with pulmonary TB OR live in a household with someone with pulmonary TB being treated at one of the participating health facilities
- •Household includes ≥2 persons
- •Age 15 years and older
- •Willingness to participate in study procedures
排除标准
- •Lives in a congregate setting (e.g., dormitory or jail)
- •Lives outside the study area
- •Any other condition that, in the opinion of the Investigator/designee, could preclude informed consent, make study participation unsafe, or otherwise interfere with achieving study objectives
研究组 & 干预措施
Home-based HIV self-testing and PrEP initiation
Home-based HIV self-testing and PrEP initiation (for eligible participants) integrated into routine TB household contact investigation
干预措施: Home-based HIV self-testing (Other)
Home-based HIV self-testing and PrEP initiation
Home-based HIV self-testing and PrEP initiation (for eligible participants) integrated into routine TB household contact investigation
干预措施: Home-based initiation of PrEP (Other)
Modified standard of care
Referral to health facility for HIV testing and PrEP initiation
结局指标
主要结局
PrEP uptake
时间窗: From enrollment to the one-month follow-up visit
Uptake of PrEP among eligible household members, measured as the proportion initiating PrEP by 1 month and found to have detectable tenofovir use at the one-month visit
次要结局
- PrEP continuation(From enrollment to six-month follow-up visit)
- HIV testing coverage(From enrollment to six-month follow-up visit)
研究者
Jennifer Ross
Assistant Professor, Department of Medicine, Division of Allergy and Infectious Diseases
University of Washington