PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

Not Applicable

Completed

• Conditions: Pre-Exposure Prophylaxis; Pregnancy Related; HIV Infections
• Interventions: Other: PrEP Optimization Interventions

• Registration Number: NCT04712994
• Lead Sponsor: University of Washington

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 Timeline

• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-19
• Study Start: 2021-05-01
• Primary Completion: 2021-11-30
• Study Completion: 2022-01-31
• Results First Submitted: 2024-02-02
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Results First Posted: 2025-01-08
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1958

Inclusion Criteria

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

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Exclusion Criteria

• Unwilling or unable to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PrEP Optimization Strategies	PrEP Optimization Interventions	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).

Primary Outcome Measures

Name	Time	Method
PrEP Penetration	6 months	Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
PrEP Fidelity	6 months	Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling
Timeliness of Services	6 months	Time (minutes) spent receiving services from health care works
Waiting Time	6 months	Time (minutes) spent waiting to receive services
HCW Acceptability	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	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	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 Outcome Measures

Name	Time	Method
PrEP Uptake	6 months	Proportion of women who accept PrEP among those offered
PrEP Continuation	6 months	Proportion of women who present for a refill among those initially prescribed PrEP
PrEP Adherence	6 months	Proportion of women who have \>80 percent adherence to PrEP by pill count among those initially prescribed PrEP
PrEP Efficiency	6 months	Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
Client PrEP Knowledge	6 months	Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions

Trial Locations

Locations (8)

Kendu Sub-District Hospital; 🇰🇪 Homa Bay, Kenya

Ober Health Center; 🇰🇪 Homa Bay, Kenya

Masogo Sub-County Hospital; 🇰🇪 Kisumu, Kenya

Madiany Sub County Hospital; 🇰🇪 Siaya, Kenya

Malanga Health Center; 🇰🇪 Siaya, Kenya

Nyahera Sub Sub County Hospital; 🇰🇪 Kisumu, Kenya

Bondo County Referral Hospital; 🇰🇪 Siaya, Kenya

Uyawi Sub County Hospital; 🇰🇪 Siaya, Kenya