PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 1,958
- Locations
- 8
- Primary Endpoint
- PrEP Penetration
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys
Exclusion Criteria
- •Unwilling or unable to provide informed consent
Arms & Interventions
PrEP Optimization Strategies
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
Intervention: PrEP Optimization Interventions (Other)
Comparator
Four facilities will be assigned to the comparator group.
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)
Investigators
Grace John-Stewart
Associate Professor, School of Medicine: Global Health
University of Washington