Actively Recruiting
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Led by University of Washington · Updated on 2025-11-19
2900
Participants Needed
3
Research Sites
182 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
A
Aurum Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 29 years old
- Assigned male sex at birth
- Identifies as male (cisgender)
- Reports condomless anal intercourse with a man in the past 6 months
- Reports multiple male sex partners or a male partner with a syndromic or laboratory-diagnosed STI 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 will not qualify if you...
- Unable to understand the study purpose and procedures
- Allergy to cephalosporin, macrolide, or tetracycline class antibiotics
- Recent use of a prolonged antibiotic course (14 days or more) in the month before enrollment
- Use of medications that affect metabolism of cefixime, azithromycin, or doxycycline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Anza Mapema Clinic
Kisumu, Kenya
Actively Recruiting
2
University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa
Mombasa, Kenya
Actively Recruiting
3
TRANSFORM Clinic
Nairobi, Kenya
Actively Recruiting
Research Team
S
Susan M Graham, MD, PhD, MPH
CONTACT
E
Eduard J Sanders, MD, PhD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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