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Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM

RecruitingPhase 4Ages 18 Years - 29 YearsMaleUniversity of Washington
NCT06468462 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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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What it tests

  • WHO-recommended periodic presumptive treatment
  • Doxycycline post-exposure prophylaxis
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Where

3 sites
Anza Mapema Clinic
Kisumu, Kenya
University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa
Mombasa, Kenya
TRANSFORM Clinic
Nairobi, Kenya
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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