CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 449 enrolled
Drug / intervention
Doxycyclinedrug
Likely dose
Doxycycline 200 mgfrom 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/NCT04050540
NCT04050540Phase 4Completed
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PrEP and dPEP: Doxycycline Post-exposure Prophylaxis for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV Pre-exposure Prophylaxis

University of Washington·interventional·Posted Aug 8, 2019·Updated Jul 10, 2024

In Brief

A Phase 4 clinical trial evaluating Doxycycline for HIV Infections and 4 related conditions. Completed, enrolled 449 participants across 1 site.

Detailed Summary

This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP). The overarching goal is to assess the effectiveness of dPEP on incidence of STIs while also balancing acceptability, cost, and impact on tetracycline resistance to inform public health policy. Participants will be randomized to receive dPEP and standard of care or the standard of care only. Questionnaires, focus group discussions, SMS, and in-depth interviews will be used to study acceptability and changes sexual behavior due to dPEP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, HIV/AIDS, Neisseria Gonorrheae Infection, Chlamydia Trachomatis Infection, Syphilis Infection
CountriesKenya
CollaboratorsKenya Medical Research Institute, Kenya National AIDS & STI Control Programme, University of California, San Francisco, National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedAug 8, 2019
Enrollment StartFeb 5, 2020
Primary CompletionOct 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.9 years ago

Interventions

Doxycyclinedrug

200 mg of doxycycline to be taken orally within 24 hours and up to 72 hours after each condomless sex act