Implementation Science Research on PrEP Delivery and Costing Within Harm Reduction Services for People Who Use Drugs in Uganda
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of PrEP uptake
研究概览
简要总结
This is an evaluation of programs to integrate PrEP into existing services for PWUD. PrEP will be delivered according to Uganda national guidelines and data from national monitoring and evaluation forms will be leveraged to address key outcomes. Additionally, research components will be implemented to support greater understanding of PrEP use and experiences of participants engaged with the PrEP programs.
详细描述
The first facility-based medication-assisted treatment (MAT) program (with methadone) in Kampala launched in 2020, providing opportunity to integrate pre-exposure prophylaxis(PrEP) as part of a comprehensive HIV prevention package. Additionally, a community-based needle and syringe exchange program (NSP) provides opportunity to integrate PrEP and meet priorities of PWID while building rapport between providers and end-users. With two different service models - integrating PrEP into facility-based MAT and community-based NSP - there is a great opportunity to optimize the integration of PrEP and other HIV prevention services for PWUD. By integrating PrEP into two existing programs (MAT and NSP), this study will determine uptake and persistence of PrEP use and leverage these programs to conduct costing research and budget impact analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accessing services from any of the programs implementing the integrated PrEP program described in this protocol
- •Able and willing to provide informed consent
- •Age ≥15 years
排除标准
- •Any clinical or chronic medical condition that in the opinion of the investigator would make the participant unsuitable for the study or unable to independently provide informed consent.
研究组 & 干预措施
Participants in PrEP and MAT programs
Integrated PrEP and MAT program
干预措施: Integrating PrEP delivery (Other)
Participants in PrEP and NSP programs
Integrated PrEP and NSP program
干预措施: Integrating PrEP delivery (Other)
结局指标
主要结局
Rate of PrEP uptake
时间窗: 12 months after enrollment
PrEP uptake will be measured through PrEP bottle inventory (bottles dispensed) in people who access NSP versus MAT.
PrEP retention
时间窗: 12 months after enrollment
PrEP retention will be measured through study visit attendance among those who access NSP versus MAT.
PrEP adherence
时间窗: 12 months after enrollment
PrEP adherence will be measured objectively through plasma tenofovir in people who access NSP versus MAT.
次要结局
- To measure the impact of knowledge gained from training peers of PWUD on PrEP.(Baseline (pre-training), immediately after training, and 3 months post training)
- To conduct a budget impact analysis for integrating PrEP into MAT and NSP programs.(12 months post study enrollment)
研究者
Renee Heffron
Associate Professor
University of Washington