PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

• Sponsor: University of Washington (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04712994
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), National Institute of Mental Health (NIMH) (NIH), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 7,680
• Locations: 8
• Arms: 2
• Anticipated Duration (Months): 38
• Patients Per Site: 960
• Patients Per Site Per Month: 25.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pre-Exposure Prophylaxis; HIV Infections; Pregnancy Related	Other: PrEP Optimization Interventions	N/A

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 strategies identified by stakeholders and 1 pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 7680 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: An interrupted-time series design will be used; this is a quasi-experimental design that compares data before an intervention is introduced to data after the intervention is introduced, and controls for time trends. Four rounds of interrupted-time series to evaluate four PrEP optimization interventions, three identified by stakeholders based on qualitative information in Aim 1, and one pre-developed package of interventions (video-based PrEP counselling, HIV Self-Testing [HIVST], and optimized PrEP delivery). Each of the four rounds of interrupted-time series evaluations will include 4 facilities receiving the intervention and 4 facilities serving as an ongoing concurrent comparator group; these 4 facilities will not receive any of the packages of interventions, but will undergo the same data collection procedures.An interrupted-time series design will be used; this is a quasi-experimental design that compares data before an intervention is introduced to data after the intervention is introduced, and controls for time trends. Four rounds of interrupted-time series to evaluate four PrEP optimization interventions, three identified by stakeholders based on qualitative information in Aim 1, and one pre-developed package of interventions (video-based PrEP counselling, HIV Self-Testing [HIVST], and optimized PrEP delivery). Each of the four rounds of interrupted-time series evaluations will include 4 facilities receiving the intervention and 4 facilities serving as an ongoing concurrent comparator group; these 4 facilities will not receive any of the packages of interventions, but will undergo the same data collection procedures.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PrEP Optimization Strategies Up to 16 facilities will be assigned one of four intervention groups (4 facilities per group). One of the intervention groups is pre-identified (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes), however the other 4 strategies have no yet been identified but will be through other activities in the PrEPARE study.	Other: PrEP Optimization Interventions; There will be four strategies or bundles of strategies tested, one bundle in each of the four interrupted-time series evaluations. Three of the bundles of strategies will be determined based on the qualitative information gathered in Aim 1 by stakeholders and are unknown at this time. One bundle of strategies is pre-developed and includes 3 components: video-based PrEP counselling, HIV Self-Testing [HIVST] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes
No Intervention: Comparator Up to 4 facilities will be assigned to the comparator group.

Outcome Measures

Primary Outcome Measures

1. Change in PrEP penetration [6 months]

   Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services

2. 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

3. Change in timeliness of services [6 months]

   Time (minutes) spent receiving services from health care works

4. Change in time waiting [6 months]

   Time (minutes) spent waiting to receive services

5. Change in HCW acceptability [6 months]

   Average Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale

6. Change in health care worker (HCW) appropriateness [6 months]

   Average Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale

7. 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

Secondary Outcome Measures

1. Change in PrEP uptake [6 months]

   Proportion of women who accept PrEP among those offered

2. Change in PrEP continuation [6 months]

   Proportion of women who present for a refill among those initially prescribed PrEP

3. Change in PrEP adherence [6 months]

   Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP

4. Change in PrEP efficiency [6 months]

   Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers

5. Change client PrEP knowledge [6 months]

   Average score of PrEP information questions based on content covered in counseling sessions

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Unwilling or unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kendu Sub-District Hospital	Homa Bay		Kenya
2	Ober Health Center	Homa Bay		Kenya
3	Masogo Sub-County Hospital	Kisumu		Kenya
4	Nyahera Sub Sub County Hospital	Kisumu		Kenya
5	Bondo County Referral Hospital	Siaya		Kenya
6	Madiany Sub County Hospital	Siaya		Kenya
7	Malanga Health Center	Siaya		Kenya
8	Uyawi Sub County Hospital	Siaya		Kenya

Sponsors and Collaborators

• University of Washington
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• National Institute of Mental Health (NIMH)
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Grace John-Stewart, MD, MPH, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grace John-Stewart, Associate Professor, School of Medicine: Global Health, University of Washington
• ClinicalTrials.gov Identifier: NCT04712994
• Other Study ID Numbers: STUDY00008392; R01HD094630; K01MH121124; R01AI125498
• First Posted: Jan 19, 2021
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Jun 30, 2022