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NCT04712994

PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

Completed NA Results posted Last updated 8 January 2025
What this trial tests

NA trial testing PrEP Optimization Interventions in Pre-Exposure Prophylaxis in 1,958 participants. Completed in 31 January 2022.

Timeline
1 May 2021
Primary endpoint
30 November 2021
31 January 2022

Quick facts

Lead sponsorUniversity of Washington
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment1,958
Start date1 May 2021
Primary completion30 November 2021
Estimated completion31 January 2022
Sites8 locations across Kenya

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

Eligibility, female only, with Pre-Exposure Prophylaxis or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PrEP Penetration Primary · 6 months

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

Baseline
GroupValue95% CI
PrEP Optimization Strategies30
Comparator17
Intervention
GroupValue95% CI
PrEP Optimization Strategies46
Comparator8
PrEP Fidelity Primary · 6 months

Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling

Baseline
GroupValue95% CI
PrEP Optimization Strategies14
Comparator4
Intervention
GroupValue95% CI
PrEP Optimization Strategies28
Comparator5
Timeliness of Services Primary · 6 months

Time (minutes) spent receiving services from health care works

Baseline
GroupValue95% CI
PrEP Optimization Strategies1812 – 36
Comparator1610 – 33
Intervention
GroupValue95% CI
PrEP Optimization Strategies1711 – 29
Comparator149 – 27.5
Waiting Time Primary · 6 months

Time (minutes) spent waiting to receive services

Baseline
GroupValue95% CI
PrEP Optimization Strategies4922.5 – 77
Comparator3714.5 – 74
Intervention
GroupValue95% CI
PrEP Optimization Strategies5531 – 80
Comparator2914 – 46.5
HCW Acceptability Primary · 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.

GroupValue95% CI
PrEP Optimization Strategies20.016.0 – 20.0
Health Care Worker (HCW) Appropriateness Primary · 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.

GroupValue95% CI
PrEP Optimization Strategies19.516.0 – 20.0
Client Satisfaction Primary · 6 months

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.

Baseline
GroupValue95% CI
PrEP Optimization Strategies21.019.0 – 23.0
Comparator23.020.0 – 23.0
Intervention
GroupValue95% CI
PrEP Optimization Strategies23.021.0 – 23.0
Comparator23.020.0 – 24.0
PrEP Uptake Secondary · 6 months

Proportion of women who accept PrEP among those offered

Baseline
GroupValue95% CI
PrEP Optimization Strategies0
Comparator1
Intervention
GroupValue95% CI
PrEP Optimization Strategies0
Comparator1
PrEP Continuation Secondary · 6 months

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

Baseline
GroupValue95% CI
PrEP Optimization Strategies1
Comparator1
Intervention
GroupValue95% CI
PrEP Optimization Strategies1
Comparator2
Client PrEP Knowledge Secondary · 6 months

Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions

Baseline
GroupValue95% CI
PrEP Optimization Strategies5
Comparator0
Intervention
GroupValue95% CI
PrEP Optimization Strategies56
Comparator5

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya.
    Sila J, Wagner AD, Abuna F, Dettinger JC, et al · · 2023 · cited 8× · PMID 38045529 · DOI 10.3389/frph.2023.1205503
  2. Comparison of methods to engage diverse stakeholder populations in prioritizing PrEP implementation strategies for testing in resource-limited settings: a cross-sectional study.
    Hicks S, Abuna F, Odhiambo B, Dettinger JC, et al · · 2023 · cited 6× · PMID 37438779 · DOI 10.1186/s43058-023-00457-9
  3. Selecting implementation strategies to improve implementation of integrated PrEP for pregnant and postpartum populations in Kenya: a sequential explanatory mixed methods analysis.
    Hicks S, Odhiambo B, Abuna F, Dettinger JC, et al · · 2023 · cited 4× · PMID 37580795 · DOI 10.1186/s43058-023-00481-9
  4. Integrating PrEP in maternal and child health clinics in Kenya: analysis of a service availability and readiness assessment (SARA) survey.
    Hicks S, Abuna F, Odhiambo B, Dettinger JC, et al · · 2023 · cited 4× · PMID 37484872 · DOI 10.3389/frph.2023.1206150
  5. Impact of a stakeholder selected implementation strategy package - fast tracking, provider re-training, and co-location - on PrEP implementation for pregnant women in antenatal care clinics in western Kenya.
    Sila J, Wagner AD, Abuna F, Dettinger JC, et al · · 2025 · PMID 40355972 · DOI 10.1186/s43058-025-00746-5
  6. Proceedings of the 15th Annual Conference on the Science of Dissemination and Implementation in Health.
    · 2023 · PMID 37794475 · DOI 10.1186/s13012-023-01299-8

Verify or expand the search:

Other trials of PrEP Optimization Interventions

Trials testing the same drug.

Other recruiting trials for Pre-Exposure Prophylaxis

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04712994.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing