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NCT Number: NCT06468462

Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM

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.

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Key information

Conditions

Gonorrhea Male Bacterial Infections Bacterial Infections and Mycoses Chlamydia (Male) Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Syphilis Syphilis Male Treponemal Infections Urogenital Diseases

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Anza Mapema Clinic, Kisumu, Kenya

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About this study

Men who have sex with men (MSM) are at high risk for gonorrhoea and chlamydia in Kenya, where nucleic acid amplification testing (NAAT) is not feasible, and most infections therefore go undiagnosed. In 2011, the WHO recommended periodic presumptive treatment (PPT) of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) infections for MSM at high risk for HIV acquisition due to condomless anal intercourse with multiple sex partners or a recent STI exposure. More recently, trials in well-resourced settings have demonstrated the efficacy of doxycycline post-exposure prophylaxis (doxyPEP) for reducing NG, CT, and syphilis infections among high-risk MSM. The goal of this study is to evaluate the impact and cost-effectiveness of WHO-recommended PPT versus doxyPEP compared to standard syndromic treatment among Kenyan MSM. This study aims to (1) evaluate the effectiveness and impact on antimicrobial resistance in NG of WHO-recommended PPT given every 3 months and of doxy-PEP taken 24-72 hours after condomless sex for reducing STI burden among Kenyan MSM; (2) assess the acceptability, feasibility, and safety of implementing WHO-recommended PPT and doxy-PEP compared to standard care among providers and patients; and (3) model the health and economic impact of scaling up WHO-recommended STI PPT and doxyPEP compared to standard of care on STI control among MSM and their partners in Kenya. We will conduct an open-label randomized trial with 2900 participants to evaluate these two interventions versus standard care assigned in a 2:2:1 ratio, with 18 months of follow-up at three MSM-friendly research clinics in Kenya. 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. This work will provide the critical data needed to inform guidelines and improve STI control among this key population in sub-Saharan Africa and other resource-limited settings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

WHO-recommended periodic presumptive treatment

Drug

400 mg po cefixime plus 1 gram azithromycin po under direct observation

Other names: WHO PPT

Doxycycline post-exposure prophylaxis

Drug

200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily

Other names: doxyPEP

Primary outcomes

  1. Number of participants with NG, CT, or early syphilis infection (combined STI outcome)

    Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization

    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.

Secondary outcomes

  1. Number of participants with Neisseria gonorrhea infection

    Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization

    The number of participants with an Aptima test on a pooled specimen (throat, rectal, and urine) positive for NG will be determined at each visit.

  2. Number of participants with Chlamydia trachomatis infection

    Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization

    The number of participants with an Aptima test on a pooled specimen (throat, rectal, and urine) positive for CT will be determined at each visit.

  3. Number of participants with early syphilis infection

    Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization

    The number of participants with 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, will be determined at each visit

Other outcomes

  1. Number of gonorrhea infections with antimicrobial resistance mutations

    Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization

    The number of gonorrhea infections with genetic determinants conferring resistance to cefixime, azithromycin or tetracycline resistance will be determined a each visit

  2. Acceptability of Intervention Measure

    Time frame: Measured every 6 months over 18 months of follow-up from the date of randomization

    The Acceptability of Intervention Measure (4 questions rated from 0 to 4) will be assessed at baseline and every 6 months thereafter in all study arms. The "intervention" assessed will be the study arm to which the participant is assigned (i.e., presumptive treatment, doxyPEP, or standard care).

  3. Feasibility of Intervention Measure

    Time frame: Measured every 6 months over 18 months of follow-up from the date of randomization

    The Feasibility of Intervention Measure (4 questions rated from 0 to 4) will be assessed at baseline and every 6 months thereafter in all study arms. The "intervention" assessed will be the study arm to which the participant is assigned (i.e., presumptive treatment, doxyPEP, or standard care).

  4. Adverse events

    Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization

    Number of adverse events, including social harms, reported by participants or study staff at each study visit

Study contacts

Contact information is provided by the study sponsor or research team.

Eduard J Sanders, MD, PhD, MPH

CONTACT

[email protected]

+254-723-593762

Susan M Graham, MD, PhD, MPH

CONTACT

[email protected]

+1-206-351-0414

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Aurum Institute
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Nyanza Reproductive Health Society
  • Partners for Health & Development in Africa

Registry information

Official study title

WHO-recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for STI Control Among Cisgender Men Who Have Sex With Men in Kenya

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 21, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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