A Phase 4 interventional study of WHO-recommended periodic presumptive treatment and Doxycycline post-exposure prophylaxis in Gonorrhea Male, Chlamydia (Male) and Syphilis Male, sponsored by University of Washington. Active, not recruiting at 3 sites in Kenya. Open to male participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Washington · Phase 4, Interventional, and Other
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.
Men who have sex with men (MSM) are at high risk for gonorrhoea and chlamydia in Kenya, where nucleic acid amplification testing (NAAT) is not feasible, and most infections therefore go undiagnosed. In 2011, the WHO recommended periodic presumptive treatment (PPT) of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) infections for MSM at high risk for HIV acquisition due to condomless anal intercourse with multiple sex partners or a recent STI exposure. More recently, trials in well-resourced settings have demonstrated the efficacy of doxycycline post-exposure prophylaxis (doxyPEP) for reducing NG, CT, and syphilis infections among high-risk MSM. The goal of this study is to evaluate the impact and cost-effectiveness of WHO-recommended PPT versus doxyPEP compared to standard syndromic treatment among Kenyan MSM. This study aims to (1) evaluate the effectiveness and impact on antimicrobial resistance in NG of WHO-recommended PPT given every 3 months and of doxy-PEP taken 24-72 hours after condomless sex for reducing STI burden among Kenyan MSM; (2) assess the acceptability, feasibility, and safety of implementing WHO-recommended PPT and doxy-PEP compared to standard care among providers and patients; and (3) model the health and economic impact of scaling up WHO-recommended STI PPT and doxyPEP compared to standard of care on STI control among MSM and their partners in Kenya. We will conduct an open-label randomized trial with 2900 participants to evaluate these two interventions versus standard care assigned in a 2:2:1 ratio, with 18 months of follow-up at three MSM-friendly research clinics in Kenya. Results will inform parameters to update a stochastic model of STI transmission and cost-effectiveness analysis to project the impact of scaled-up STI PPT and doxyPEP in Kenya. This work will provide the critical data needed to inform guidelines and improve STI control among this key population in sub-Saharan Africa and other resource-limited settings.
134 studies on the registry are indexed under Chlamydia Infections; 23 are open to participants now.
This study's planned enrollment of 2,900 is above the median of 600 across 94 interventional studies indexed under Chlamydia Infections.
Browse Chlamydia Infections studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the STI PPT arm will be evaluated at baseline and every 3 months thereafter for STI PPT eligibility based on having had condomless anal sex and either multiple sex partners or a sex partner with an STI in the past 6 months. If eligible, they will be offered 400 mg po cefixime plus 1 gram azithromycin po under direct observation, using the same regimen as for syndromic treatment per the latest WHO recommendations.
Drug: WHO-recommended periodic presumptive treatment
Participants assigned to the doxyPEP arm will be provided with a 30-day supply of doxycycline hyclate at each quarterly visit, with refills as needed. They will have 1:1 counselling on the self-administration of 200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily if indicated but not more than once daily, in accordance with the doxyPEP trial in the United States.
Drug: Doxycycline post-exposure prophylaxis
Participants assigned to the standard care arm will receive screening for STI symptoms at every scheduled visit and syndromic treatment with cefixime 400 mg po stat plus azithromycin 1 gram po stat under direct observation, in accordance with current Kenyan recommendations for genital and anorectal infections. This regimen will be updated if Kenyan recommendations change.
400 mg po cefixime plus 1 gram azithromycin po under direct observation
Also known as: WHO PPT
200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily
Also known as: doxyPEP
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.
Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization
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.
Time frame: 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.
Time frame: 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
Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization
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
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All data produced in the course of the project will be preserved and shared. The final dataset will include self-reported demographic and behavioral data from interviews with participants, clinical data from participant symptoms and focused physical exams, and laboratory data from blood and genitourinary specimens provided. We will share de-identified individual-participant level data. Appropriate measures such as expert determination to identify for removal any specific variables that could potentially lead to identification of individuals. Plans for data de-identification and sharing will be reflected in the informed consent forms. To facilitate interpretation of the data, a data dictionary describing all variables in the dataset, the study protocol, and all data collection instruments will be created, shared, and associated with the relevant datasets. Documentation and support materials will be compatible with the clinicaltrials.gov Protocol Registration Data Elements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be made available indefinitely from year 5 of the 5-year funded grant cycle.
Access criteria: Due to ethical considerations, access, distribution, and reuse of the resulting scientific data will be limited to collaborations in which a formal data sharing agreement is developed and approved by the University of Washington and Kenyatta National Hospital Ethical Review Boards.
Started Oct 2025 (actual). Primary completion is estimated for Oct 2028, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.