Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
NCT Number: NCT06468462
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Gonorrhea Male|Chlamydia (Male)|Syphilis Male
Interventions: DRUG: WHO-recommended periodic presumptive treatment|DRUG: Doxycycline post-exposure prophylaxis
Sponsor: University of Washington
Collaborators: Aurum Institute|Nyanza Reproductive Health Society|Partners for Health and Development in Africa|National Institute of Allergy and Infectious Diseases (NIAID)
Sex: MALE
Age: ADULT
Enrollment: 2900
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2028-07-30

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.

Primary Outcome Measures: Number of participants with NG, CT, or early syphilis infection (combined STI outcome), The number of participants with the combined STI outcome will be determined at each visit. The combined STI outcome will be positive when any Aptima test on a pooled specimen (throat, rectal, and urine) is positive for CT or NG or any participant tests positive for early syphilis infection, defined as a positive rapid plasma reagin \[RPR\] in a previously negative participant or a fourfold increase in non-treponemal titres for participants with a history of syphilis., Over 18 months of follow-up at quarterly visits from the date of randomization
Secondary Outcome Measures: Number of participants with Neisseria gonorrhea infection, The number of participants with an Aptima test on a pooled specimen (throat, rectal, and urine) positive for NG will be determined at each visit., Over 18 months of follow-up at quarterly visits from the date of randomization|Number of participants with Chlamydia trachomatis infection, The number of participants with an Aptima test on a pooled specimen (throat, rectal, and urine) positive for CT will be determined at each visit., Over 18 months of follow-up at quarterly visits from the date of randomization|Number of participants with early syphilis infection, The number of participants with early syphilis infection, defined as a positive rapid plasma reagin \[RPR\] in a previously negative participant or a fourfold increase in non-treponemal titres for participants with a history of syphilis, will be determined at each visit, Over 18 months of follow-up at quarterly visits from the date of randomization
Other Outcome Measures: Number of gonorrhea infections with antimicrobial resistance mutations, The number of gonorrhea infections with genetic determinants conferring resistance to cefixime, azithromycin or tetracycline resistance will be determined a each visit, Over 18 months of follow-up at quarterly visits from the date of randomization|Acceptability of Intervention Measure, The Acceptability of Intervention Measure (4 questions rated from 0 to 4) will be assessed at baseline and every 6 months thereafter in all study arms. The "intervention" assessed will be the study arm to which the participant is assigned (i.e., presumptive treatment, doxyPEP, or standard care)., Measured every 6 months over 18 months of follow-up from the date of randomization|Feasibility of Intervention Measure, The Feasibility of Intervention Measure (4 questions rated from 0 to 4) will be assessed at baseline and every 6 months thereafter in all study arms. The "intervention" assessed will be the study arm to which the participant is assigned (i.e., presumptive treatment, doxyPEP, or standard care)., Measured every 6 months over 18 months of follow-up from the date of randomization|Adverse events, Number of adverse events, including social harms, reported by participants or study staff at each study visit, Over 18 months of follow-up at quarterly visits from the date of randomization