Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
WHO-recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for STI Control Among Cisgender Men Who Have Sex With Men in Kenya
University of Washington
2,900 participants
Oct 29, 2025
INTERVENTIONAL
Conditions
Summary
Men who have sex with men (MSM) are at high risk for gonorrhea and chlamydia in Kenya, where nucleic acid amplification testing is not feasible and most infections therefore go undiagnosed. We propose an open-label randomized clinical trial with 2900 participants assigned to WHO-recommended periodic presumptive treatment (PPT) or doxycycline post-exposure prophylaxis (doxyPEP), compared to standard syndromic treatment, with 18 months of follow-up and rigorous culture-based and molecular analysis of antimicrobial resistance in Neisseria gonorrhoeae. This work will provide critical data needed to inform guidelines and improve STI control among MSM in sub-Saharan Africa and other resource-limited settings, including modelled estimates of the health and economic impact of scaling up these two interventions on STI control among MSM and their partners in Kenya.
Eligibility
Inclusion Criteria7
- -29 years old
- Assigned male sex at birth
- Identifies as male (cis-gender)
- Reports condomless anal intercourse with a man in the past 6 months
- Reports multiple male sex partners OR a male sex partner with a syndromic (urethritis, proctitis, or genital ulcer disease) or laboratory-diagnosed sexually transmitted infection in the past 6 months
- Willing and able to provide written informed consent and participate in all study procedures
- Planning to remain in the study area for 18 months
Exclusion Criteria4
- Unable to understand the study purpose and procedures
- Allergy to cephalosporin (cefixime), macrolide (erythromycin or azithromycin), or tetracycline (doxycycline) class antibiotics
- Recent use of prolonged antibiotics (≥14-day course in the month before enrolment)
- Use of medications that impact cefixime, azithromycin, or doxycycline metabolism (check versus list in screening SOP)
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Interventions
400 mg po cefixime plus 1 gram azithromycin po under direct observation
200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06468462