Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,173
- 试验地点
- 1
- 主要终点
- Change in PrEP Penetration
研究概览
简要总结
This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.
详细描述
This study aims to improve integrated delivery of PrEP to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized PrEP delivery. Strategies to be tested include three packages of strategies identified by stakeholders.
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 100 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys
排除标准
- •Unwilling or unable to provide informed consent
研究组 & 干预措施
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
干预措施: PrEP Optimization Interventions (Other)
Comparator for Package 1
4 facilities were assigned to the comparator group and never received any implementation strategy.
Package 2
Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH
干预措施: PrEP Optimization Interventions (Other)
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
干预措施: PrEP Optimization Interventions (Other)
Comparison for Package 2
4 facilities were assigned to the comparator group and never received any implementation strategy.
Comparison for Package 3
4 facilities were assigned to the comparator group and never received any implementation strategy.
结局指标
主要结局
Change in PrEP Penetration
时间窗: 6 months
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
Change in PrEP Fidelity
时间窗: 6 months
Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling. Assessed among the subset of women who are due for an HIV test, as per Kenyan guidelines, which is a subset of the overall sample.
Timeliness of Services
时间窗: 6 months
Time (minutes) spent receiving services from health care workers
Waiting Time
时间窗: 6 months
Time (minutes) spent waiting to receive services
HCW Acceptability
时间窗: 6 months
Total on 4 item Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
Health Care Worker (HCW) Appropriateness
时间窗: 6 months
Total on 4 item Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
Client Satisfaction
时间窗: 6 months
Total on 7 item exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale. The minimum score on the 7 items is 7 points (scoring 1 on each of the 7 items) while the maximum is 24 points (scoring 4 on each of the 7 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
次要结局
- PrEP Uptake(6 months)
- PrEP Continuation(6 months)
- Client PrEP Knowledge(6 months)
- PrEP Adherence(6 months)
- PrEP Efficiency(6 months)
研究者
Anjuli Wagner
Assistant Professor, Global Health
University of Washington