Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
NCT ID: NCT06468462
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2900 participants
INTERVENTIONAL
2025-10-29
2029-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Approach for objective 1: We will conduct an open-label randomized clinical trial with 2900 participants to evaluate these two interventions versus the standard of care assigned in a 2:2:1 ratio, with 18 months of follow-up and rigorous culture-based and molecular analysis of AMR in NG at three MSM-friendly research clinics in Kenya.
Approach for objective 2: We will use multidisciplinary science to measure the acceptability, feasibility, and safety of these two interventions, using a conceptual model based on Proctor's Implementation Science Framework.
Approach for objective 3: Aim 1 and 2 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.
OTHER
SINGLE
Study Groups
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WHO-recommended periodic presumptive treatment
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.
WHO-recommended periodic presumptive treatment
400 mg po cefixime plus 1 gram azithromycin po under direct observation
Doxycycline post-exposure prophylaxis
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.
Doxycycline post-exposure prophylaxis
200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily
Standard care
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.
No interventions assigned to this group
Interventions
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WHO-recommended periodic presumptive treatment
400 mg po cefixime plus 1 gram azithromycin po under direct observation
Doxycycline post-exposure prophylaxis
200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
29 Years
MALE
Yes
Sponsors
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Aurum Institute
OTHER
Nyanza Reproductive Health Society
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Partners for Health & Development in Africa
UNKNOWN
University of Washington
OTHER
Responsible Party
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Susan Graham
Professor: Global Health
Principal Investigators
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Susan M Graham, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Anza Mapema Clinic
Kisumu, , Kenya
University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa
Mombasa, , Kenya
TRANSFORM Clinic
Nairobi, , Kenya
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY00018588
Identifier Type: -
Identifier Source: org_study_id
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