PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.

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 a pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).

• Study Type: Interventional
• Enrollment (Actual): 1958
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Homa Bay, Kenya
    • Kendu Sub-District Hospital
  • Homa Bay, Kenya
    • Ober Health Center
  • Kisumu, Kenya
    • Masogo Sub-County Hospital
  • Kisumu, Kenya
    • Nyahera Sub Sub County Hospital
  • Siaya, Kenya
    • Bondo County Referral Hospital
  • Siaya, Kenya
    • Madiany Sub County Hospital
  • Siaya, Kenya
    • Malanga Health Center
  • Siaya, Kenya
    • Uyawi Sub County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: PrEP Optimization Interventions; A bundle of strategies (video-based PrEP counselling, HIV Self-Testing [HIVST] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
No Intervention: Comparator; Four facilities will be assigned to the comparator group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Penetration	Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services	6 months
PrEP Fidelity	Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling	6 months
Timeliness of Services	Time (minutes) spent receiving services from health care works	6 months
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
Client Satisfaction	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.	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 Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Grace John-Stewart, MD, MPH, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

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; R01HD094630 (U.S. NIH Grant/Contract); R01AI125498 (U.S. NIH Grant/Contract)

Drug and device information, study documents

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