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New treatment option for Gonorrhea Male
Official title Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
ClinicalTrials.gov ID: NCT06468462
What this study is testing
What is WHO-recommended periodic presumptive treatment?
WHO-recommended periodic presumptive treatment is an investigational medicine, being studied as a potential treatment for gonorrhea male.
Also referred to as WHO PPT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 29, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Kisumu, Kenya
- Mombasa, Kenya
- Nairobi, Kenya
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 29 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kisumu, Kenya; Mombasa, Kenya; Nairobi, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.