CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25,457 enrolled
Drug / intervention
PrEPdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04666792
NCT04666792Phase 4Completed
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PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya

University of Washington·interventional·Posted Dec 14, 2020·Updated Sep 4, 2025

In Brief

A Phase 4 clinical trial evaluating PrEP for HIV Infections and 2 related conditions. Completed, enrolled 25,457 participants across 1 site.

Detailed Summary

This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Contraception, STI
CountriesKenya
CollaboratorsNational Institute of Mental Health (NIMH), Kenyatta National Hospital, Kenya National AIDS & STI Control Programme, Kisumu County Government

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedDec 14, 2020
Enrollment StartMar 1, 2021
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 5.5 years ago

Interventions

PrEPdrug

A fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks.