PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
NCT ID: NCT04712994
Last Updated: 2025-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1958 participants
INTERVENTIONAL
2021-05-01
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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).
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.
Comparator
Four facilities will be assigned to the comparator group.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Washington
OTHER
Responsible Party
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Grace John-Stewart
Associate Professor, School of Medicine: Global Health
Principal Investigators
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Grace John-Stewart, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Kendu Sub-District Hospital
Homa Bay, , Kenya
Ober Health Center
Homa Bay, , Kenya
Masogo Sub-County Hospital
Kisumu, , Kenya
Nyahera Sub Sub County Hospital
Kisumu, , Kenya
Bondo County Referral Hospital
Siaya, , Kenya
Madiany Sub County Hospital
Siaya, , Kenya
Malanga Health Center
Siaya, , Kenya
Uyawi Sub County Hospital
Siaya, , Kenya
Countries
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References
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Sila J, Wagner AD, Abuna F, Dettinger JC, Odhiambo B, Ngumbau N, Oketch G, Sifuna E, Gomez L, Hicks S, John-Stewart G, Kinuthia J. 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. Front Reprod Health. 2023 Nov 17;5:1205503. doi: 10.3389/frph.2023.1205503. eCollection 2023.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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