Phase 4
Completed N=449
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
HIV · Neisseria Gonorrheae Infection · Chlamydia trachomatis infection · Syphilis Infection
Source: ClinicalTrials.gov NCT04050540 ↗
Enrolled (actual)
449
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Incidence of N. Gonorrhoeae, C. Trachomatis, or Early Syphilis Infection by Laboratory-based Diagnosis — 25.1; 29.0 Events per 100 person-years
◆ Published Evidence
Highly cited
114citations · ~38 / year
Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women.
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.
Linked Publications (3)
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Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women.
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Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial.
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Understanding barriers and facilitators to doxycycline post-exposure prophylaxis adherence among young women in western kenya: a qualitative study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of N. Gonorrhoeae, C. Trachomatis, or Early Syphilis Infection by Laboratory-based Diagnosis |
25.1; 29.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 1 partner of unknown status, transactional sex, recent STI, recurrent HIV PEP use, inconsistent condom use, or injection drug use).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04050540) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.