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Clinical Trials/NCT05482360
NCT05482360
Completed
Not Applicable

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

University of Washington1 site in 1 country5,173 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-Exposure Prophylaxis
Sponsor
University of Washington
Enrollment
5173
Locations
1
Primary Endpoint
Change in 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 an interrupted time series.

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 three packages of strategies identified by stakeholders.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anjuli Wagner

Assistant Professor, 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

Change in PrEP Penetration

Time Frame: 6 months

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

Change in 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. 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

Time Frame: 6 months

Time (minutes) spent receiving services from health care workers

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 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.

Secondary Outcomes

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

Study Sites (1)

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