跳至主要内容
临床试验/NCT05482360
NCT05482360已完成不适用

Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)

University of Washington1 个研究点 分布在 1 个国家目标入组 5,173 人开始时间: 2022年1月1日最近更新:
适应症

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

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

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 Continuation(6 months)
  • PrEP Uptake(6 months)
  • Client PrEP Knowledge(6 months)
  • PrEP Adherence(6 months)
  • PrEP Efficiency(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anjuli Wagner

Assistant Professor, Global Health

University of Washington

研究点 (1)

Loading locations...

相似试验

Testing Implementation Strategies to Improve... | 临床试验