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Mass STI treatment or pill after sex? major trial tests best bet for kenyan men

NCT ID NCT06468462

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 29 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Anza Mapema Clinic

    RECRUITING

    Kisumu, Kenya

  • TRANSFORM Clinic

    RECRUITING

    Nairobi, Kenya

  • University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa

    RECRUITING

    Mombasa, Kenya

More trials for these conditions

Other studies related to the condition(s) this trial covers.