Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Recruiting now · Phase 4
Conditions studied: Gonorrhea Male, Chlamydia (Male), Syphilis Male
In brief
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.
Key facts
- Study ID
- NCT06468462
- Run by
- University of Washington
- People needed
- 2900
- Starts
- 2025-10-29
- Expected to finish
- 2029-04-30
- Last updated by the study team
- 2025-11-19
Who can join
Age: 18 and older, up to 29. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 18-29 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
You may not qualify if…
- 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)
Where it is running
- Anza Mapema Clinic — Kisumu, Kenya (enrolling)
- University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa — Mombasa, Kenya (enrolling)
- TRANSFORM Clinic — Nairobi, Kenya (enrolling)
Full record on ClinicalTrials.gov
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