Status:
COMPLETED
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Kenya Medical Research Institute
Kenya National AIDS & STI Control Programme
Conditions:
HIV Infections
HIV/AIDS
Eligibility:
FEMALE
18-30 years
Phase:
PHASE4
Brief 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 asses...
Detailed Description
This study is an open-label 1:1 randomized clinical trial of doxycyline PEP to reduce bacterial STIs - Neisseria gonorrhoeae, Chlamydia trachomatis, and T. pallidum (syphilis) - among Kenyan women tak...
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent
- Age ≥18 years and ≤30 years old
- Female sex at birth
- HIV-seronegative at the time of last test within the past month and a current prescription for PrEP according to the national guidelines of Kenya (define PrEP eligibility as: partner of HIV-infected person not on ART or on ART for \<6 months, \>1 partner of unknown status, transactional sex, recent STI, recurrent HIV PEP use, inconsistent condom use, or injection drug use).
Exclusion
- Pregnant
- Breastfeeding a child
- Allergy to tetracycline class
- Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, phenytoin, and warfarin.
- Recent use of prolonged (more than 14 day course) antibiotics in the month prior to enrollment
- Active, clinically significant medical or psychiatric conditions that would interfere with study participation, at the discretion of the site investigator or designee.
Key Trial Info
Start Date :
February 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
449 Patients enrolled
Trial Details
Trial ID
NCT04050540
Start Date
February 5 2020
End Date
October 30 2022
Last Update
July 10 2024
Active Locations (1)
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1
Kenya Medical Research Institute
Kisumu, Kenya