Periodic presumptive treatment versus doxycycline post-exposure prophylaxis for STI control in Kenyan men who have sex with men
WHO-recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for STI Control Among Cisgender Men Who Have Sex With Men in Kenya
This study will test whether periodic presumptive treatment or doxycycline taken after sex better prevents gonorrhea, chlamydia, and syphilis in Kenyan men who have sex with men.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2900 (estimated) |
| Ages | 18 Years to 29 Years |
| Sex | Male |
| Sponsor | University of Washington Academic / other |
| Locations | 3 sites (Kisumu and 2 other locations) |
| Trial ID | NCT06468462 on ClinicalTrials.gov |
What this trial studies
This is an open-label, randomized Phase 4 trial enrolling 2,900 Kenyan men who have sex with men to compare WHO-recommended periodic presumptive treatment (given every 3 months) and doxycycline post-exposure prophylaxis (taken 24–72 hours after condomless sex) against current syndromic care. Participants will be followed for 18 months with clinical monitoring and rigorous culture-based and molecular testing of Neisseria gonorrhoeae to track infections and antimicrobial resistance. The study will also collect data on acceptability, feasibility, and safety of the two interventions among providers and patients. Modeling analyses will estimate the health and economic impact of scaling up PPT or doxyPEP for STI control among MSM and their partners in Kenya.
Who should consider this trial
Good fit: Ideal candidates are cisgender men aged 18–29 who were assigned male at birth, report condomless anal intercourse with men in the past 6 months plus multiple partners or a partner with a recent STI exposure, can consent, and plan to remain in the study area for 18 months.
Not a fit: People who are allergic to cefixime, macrolides, or tetracyclines, who recently completed a prolonged antibiotic course, who take medications that interact with the study drugs, or who do not meet the age/gender/behavior criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the interventions could substantially reduce STI incidence among Kenyan MSM and provide evidence to guide safer, more effective STI control strategies in similar resource-limited settings.
How similar studies have performed: Trials in well-resourced settings have shown doxyPEP reduces gonorrhea, chlamydia, and syphilis among high-risk MSM, while WHO-recommended periodic presumptive treatment has prior endorsement but limited contemporary data on antimicrobial resistance and implementation in low-resource settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Kisumu and 2 other locations
- Anza Mapema Clinic — Kisumu, Kenya (Recruiting)
- University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa — Mombasa, Kenya (Recruiting)
- TRANSFORM Clinic — Nairobi, Kenya (Recruiting)
Study contacts
- Principal investigator: Susan M Graham, MD, PhD, MPH — University of Washington
- Study coordinator: Susan M Graham, MD, PhD, MPH
- Email: grahamsm@uw.edu
- Phone: +1-206-351-0414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.