An Implementation Project to Improve the Efficiency of PrEP Delivery in Public Health HIV Care Clinics in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 746
- 试验地点
- 1
- 主要终点
- Acceptability of user HIV self-testing for PrEP care pathway
研究概览
简要总结
This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.
详细描述
A prospective, pilot implementation evaluation of patient-centered differentiated care service. The core components of the multifaceted implementation strategy include: 1) 3-monthly refills, 2) direct-to-pharmacy refill visits, 3) HIV self-testing (HIVST) while waiting for refills, 4) Rapid risk assessment for ongoing risk, adherence, side effect, and acute HIV symptoms. Clinics will implement either: 1) current PrEP patient flow without any change or 2) a pilot differentiated pharmacy-based follow up PrEP care pathway. Clinics will implement only one delivery model thus eliminating risk for confusion in the clinic about delivery models and permitting a full-scale test of the system, since the efficiency in PrEP delivery is in part at the system level, above and beyond the individual client encounter. For this pilot project designed to primarily test delivery efficiency, feasibility and acceptability of direct-to-pharmacy care pathway at systems level using existing public health infrastructure, pilot and control clinics will be of comparable size selected to reflect the implementation nature of the design.
The specific aims are:
Aim 1: To evaluate whether a differentiated care model improves the efficiency of PrEP delivery while resulting in equivalent or better: 1) patient waiting time, 2) early PrEP continuation, and 3) adherence.
Aim 2: Conduct mixed-methods study to understand patient and provider perception, experiences , feasibility and acceptability of a differentiated PrEP delivery model.
Aim 3: Assess the efficiency, cost and cost-effectiveness of a facility-based differentiated PrEP care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For HIV-negative participants:
- •Of legal age (≥18 years)
- •Able and willing to provide written informed consent for research component of the project (blood draw for adherence, brief surveys and in-depth qualitative interviews)
- •HIV uninfected based on negative HIV tests, per Kenya national guidelines
- •Currently or previously accessed PrEP at participating HIV clinic
- •For Key delivery informants:
- •Able willing and able to provide consent in order to participate in the survey and qualitative interviews.
- •Works at any of the clinics implementing PrEP delivery. Key informants may include HIV testing service nurses, counselors, clinicians, social workers, or clinic managers.
排除标准
- •Not meeting any of the inclusion criteria listed above.
研究组 & 干预措施
Direct-to-pharmacy oral PrEP refill visits
Intervention
干预措施: Direct-to-pharmacy oral PrEP refill visits (Other)
Usual care
Control
结局指标
主要结局
Acceptability of user HIV self-testing for PrEP care pathway
时间窗: up to 6 months
Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
Acceptability of direct-to-pharmacy PrEP care pathway
时间窗: up to 6 months
Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
Patient wait time
时间窗: up to 6 months
Total waiting time at the clinic and contact time with providers measured by time and motion studies
PrEP continuation
时间窗: up to 6 months
Measured by return to clinic for PrEP refill
PrEP adherence
时间窗: up to 6 months
Measured objectively through tenofovir levels in dried blood spots at random subset of PrEP visits
Feasibility of direct-to-pharmacy PrEP care pathway
时间窗: up to 6 months
Assessed by the Feasibility of Intervention Psychometric Measure (FIM)
次要结局
- Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics(up to 6 months)
- Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics(up to 6 months)
- Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics(up to 6 months)
- Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics(up to 6 months)
- Safety of HIV self-testing(up to 6 moths)
- Reasons for PrEP discontinuation(up to 6 months)
研究者
Kenneth K Mugwanya
Assistant Professor, School of Medicine: Global Health
University of Washington