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

NCT06468462 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2900

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • Gonorrhea Male
  • Chlamydia (Male)
  • Syphilis Male

Interventions

DRUG

Doxycycline post-exposure prophylaxis

200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily

DRUG

WHO-recommended periodic presumptive treatment

400 mg po cefixime plus 1 gram azithromycin po under direct observation

Sponsors & Collaborators

  • Aurum Institute

    collaborator OTHER

  • Nyanza Reproductive Health Society

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Partners for Health & Development in Africa

    collaborator UNKNOWN

  • University of Washington

    lead OTHER

Principal Investigators

  • Susan M Graham, MD, PhD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-29
Primary Completion
2028-10-31
Completion
2029-04-30

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468462 on ClinicalTrials.gov