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Clinical Trials/NCT04712994
NCT04712994
Completed
Not Applicable

PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

University of Washington8 sites in 1 country1,958 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-Exposure Prophylaxis
Sponsor
University of Washington
Enrollment
1958
Locations
8
Primary Endpoint
PrEP Penetration
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
January 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Grace John-Stewart

Associate Professor, School of Medicine: Global Health

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys

Exclusion Criteria

  • Unwilling or unable to provide informed consent

Outcomes

Primary Outcomes

PrEP Penetration

Time Frame: 6 months

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

PrEP Fidelity

Time Frame: 6 months

Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling

Timeliness of Services

Time Frame: 6 months

Time (minutes) spent receiving services from health care works

Waiting Time

Time Frame: 6 months

Time (minutes) spent waiting to receive services

HCW Acceptability

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (8)

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