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

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

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Pregnancy Related; Pre-Exposure Prophylaxis
• Intervention / Treatment: Other: PrEP Optimization Interventions

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 Type: Interventional
• Enrollment (Actual): 5173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Homa Bay, Kenya
    • Ober Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unwilling or unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Package 1; Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH	Other: PrEP Optimization Interventions; There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
No Intervention: Comparator for Package 1; 4 facilities were assigned to the comparator group and never received any implementation strategy.
Experimental: Package 2; Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH	Other: PrEP Optimization Interventions; There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
Experimental: Package 3; Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH	Other: PrEP Optimization Interventions; There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
No Intervention: Comparison for Package 2; 4 facilities were assigned to the comparator group and never received any implementation strategy.
No Intervention: Comparison for Package 3; 4 facilities were assigned to the comparator group and never received any implementation strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waiting Time	Time (minutes) spent waiting to receive services	6 months
HCW Acceptability	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.	6 months
Health Care Worker (HCW) Appropriateness	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.	6 months
Change in PrEP Penetration	Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services	6 months
Change in PrEP Fidelity	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.	6 months
Timeliness of Services	Time (minutes) spent receiving services from health care workers	6 months
Client Satisfaction	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.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Anjuli Wagner, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: STUDY00008392-A; K01MH121124 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No