Mass STI treatment or pill after sex? major trial tests best bet for kenyan men
NCT ID NCT06468462
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests two strategies to control sexually transmitted infections (STIs) among 2,900 cisgender men who have sex with men in Kenya. One group gets a single dose of antibiotics every few months (WHO-recommended periodic presumptive treatment), another takes doxycycline within 72 hours after condomless sex (doxyPEP), and a third gets standard care. The goal is to see which approach best reduces new infections of gonorrhea, chlamydia, and syphilis over 18 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cefixime, azithromycin, and doxycycline
- What this could lead to
- If successful, this could provide an effective, scalable strategy to reduce gonorrhea, chlamydia, and syphilis in high-risk men in resource-limited settings.
- What could go wrong
- This is a single open-label trial in Kenya, so results may not apply elsewhere. Antibiotic resistance is a concern, and the interventions may not be as effective in real-world conditions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 2,900 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 29 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anza Mapema Clinic
RECRUITINGKisumu, Kenya
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TRANSFORM Clinic
RECRUITINGNairobi, Kenya
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University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa
RECRUITINGMombasa, Kenya
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