Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
- Conditions
- Pre-Exposure ProphylaxisHIV InfectionsPregnancy 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 5173
- Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys
- Unwilling or unable to provide informed consent
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 PrEP Fidelity 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 6 months Time (minutes) spent receiving services from health care workers
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 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 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
Client PrEP Knowledge 6 months Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions
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
Trial Locations
- Locations (1)
Ober Health Center
🇰🇪Homa Bay, Kenya