Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
WHO-recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for STI Control Among Cisgender Men Who Have Sex With Men in Kenya
2 other identifiers
interventional
2,900
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2025
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2024
CompletedFirst Posted
Study publicly available on registry
June 21, 2024
CompletedStudy Start
First participant enrolled
October 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
November 19, 2025
November 1, 2025
3 years
June 1, 2024
November 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Over 18 months of follow-up at quarterly visits from the date of randomization
Secondary Outcomes (3)
Number of participants with Neisseria gonorrhea infection
Over 18 months of follow-up at quarterly visits from the date of randomization
Number of participants with Chlamydia trachomatis infection
Over 18 months of follow-up at quarterly visits from the date of randomization
Number of participants with early syphilis infection
Over 18 months of follow-up at quarterly visits from the date of randomization
Other Outcomes (4)
Number of gonorrhea infections with antimicrobial resistance mutations
Over 18 months of follow-up at quarterly visits from the date of randomization
Acceptability of Intervention Measure
Measured every 6 months over 18 months of follow-up from the date of randomization
Feasibility of Intervention Measure
Measured every 6 months over 18 months of follow-up from the date of randomization
- +1 more other outcomes
Study Arms (3)
WHO-recommended periodic presumptive treatment
ACTIVE COMPARATORParticipants 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.
Doxycycline post-exposure prophylaxis
ACTIVE COMPARATORParticipants 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.
Standard care
NO INTERVENTIONParticipants 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.
Interventions
400 mg po cefixime plus 1 gram azithromycin po under direct observation
200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Aurum Institutecollaborator
- Nyanza Reproductive Health Societycollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Partners for Health & Development in Africacollaborator
Study Sites (3)
Anza Mapema Clinic
Kisumu, Kenya
University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa
Mombasa, Kenya
TRANSFORM Clinic
Nairobi, Kenya
Related Publications (1)
Graham SM, Otieno FO, Kimani J, Barrientos A, Soge OO, Sharma M, Hamilton DT, Celum C, McClelland RS, Sanders EJ. World Health Organization-Recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for Sexually Transmitted Infection Control Among Men Who Have Sex With Men in Kenya: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 6;15:e81113. doi: 10.2196/81113.
PMID: 41494183DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M Graham, MD, PhD, MPH
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Aptima Combo 2 testing for NG and CT will be conducted in Mombasa on a Hologic Panther platform by experienced laboratory staff blinded to randomization assignment.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor: Global Health
Study Record Dates
First Submitted
June 1, 2024
First Posted
June 21, 2024
Study Start
October 29, 2025
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
April 30, 2029
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, 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.
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.