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临床试验/NCT04712994
NCT04712994已完成不适用

PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

University of Washington8 个研究点 分布在 1 个国家目标入组 1,958 人开始时间: 2021年5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
1,958
试验地点
8
主要终点
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 a difference-in-difference approach.

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 a pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).

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

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

PrEP Penetration

时间窗: 6 months

Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services

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

Timeliness of Services

时间窗: 6 months

Time (minutes) spent receiving services from health care works

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 6 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 6 items is 6 points (scoring 1 on each of the 6 items) while the maximum is 24 points (scoring 4 on each of the 6 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)
  • PrEP Adherence(6 months)
  • PrEP Efficiency(6 months)
  • Client PrEP Knowledge(6 months)

研究者

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

Grace John-Stewart

Associate Professor, School of Medicine: Global Health

University of Washington

研究点 (8)

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