Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya

Not Applicable

Completed

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

• Registration Number: NCT05482360
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5690

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	Up to 12 facilities will be assigned one of three intervention groups (4 facilities per group). The strategies have no yet been identified but will be through other activities in the PrEPARE study.

Primary Outcome Measures

Name	Time	Method
Change in PrEP penetration	6 months	Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
Change in time waiting	6 months	Time (minutes) spent waiting to receive services
Change in health care worker (HCW) appropriateness	6 months	Average Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale
Change in PrEP fidelity	6 months	Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling
Change in client satisfaction	6 months	Exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale
Change in timeliness of services	6 months	Time (minutes) spent receiving services from health care works
Change in HCW acceptability	6 months	Average Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale

Secondary Outcome Measures

Name	Time	Method
Change in PrEP adherence	6 months	Proportion of women who have \>80 percent adherence to PrEP by pill count among those initially prescribed PrEP
Change in PrEP uptake	6 months	Proportion of women who accept PrEP among those offered
Change in PrEP continuation	6 months	Proportion of women who present for a refill among those initially prescribed PrEP
Change in PrEP efficiency	6 months	Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
Change client PrEP knowledge	6 months	Average score of PrEP information questions based on content covered in counseling sessions

Trial Locations

Locations (1)

Ober Health Center; 🇰🇪 Homa Bay, Kenya