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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI179838-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Aurum Institute | OTHER |
| Nyanza Reproductive Health Society | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Partners for Health & Development in Africa |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WHO-recommended periodic presumptive treatment | Active Comparator | 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. |
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| Doxycycline post-exposure prophylaxis | Active Comparator | 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. |
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| Standard care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WHO-recommended periodic presumptive treatment | Drug | 400 mg po cefixime plus 1 gram azithromycin po under direct observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Neisseria gonorrhea infection | 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. | Over 18 months of follow-up at quarterly visits from the date of randomization |
| Number of participants with Chlamydia trachomatis infection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of gonorrhea infections with antimicrobial resistance mutations | The number of gonorrhea infections with genetic determinants conferring resistance to cefixime, azithromycin or tetracycline resistance will be determined a each visit | Over 18 months of follow-up at quarterly visits from the date of randomization |
Inclusion Criteria:
Exclusion Criteria:
identifies as male (cis-gender)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan M Graham, MD, PhD, MPH | Contact | +1-206-351-0414 | grahamsm@uw.edu | |
| Eduard J Sanders, MD, PhD, MPH | Contact | +254-723-593762 | esanders@auruminstitute.org |
| Name | Affiliation | Role |
|---|---|---|
| Susan M Graham, MD, PhD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anza Mapema Clinic | Recruiting | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41873979 | Derived | Ochieng F, Wambua P, Kimani J, Wanjiru M, Agingu W, Kabuti R, Mdletshe N, McKinnon LR, Otieno FO, Mehta SD. Prevalence of and Factors Associated With Urethral and Rectal STIs Among a Cross-Sectional Sample Men Who Have Sex With Men. Sex Transm Dis. 2026 Jul 1;53(7):435-443. doi: 10.1097/OLQ.0000000000002320. Epub 2026 Mar 24. | |
| 41494183 | Derived | 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. |
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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.
Data will be made available indefinitely from year 5 of the 5-year funded grant cycle.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2024 | Oct 13, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2024 | Oct 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| UNKNOWN |
The proposed study is an open-label randomized controlled trial with a hybrid type 1 implementation-effectiveness component comparing each intervention (i.e., STI PPT, doxyPEP) to a common control in a 2:2:1 ratio.
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.
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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.
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| Doxycycline post-exposure prophylaxis | Drug | 200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily |
|
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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. |
| Over 18 months of follow-up at quarterly visits from the date of randomization |
| Number of participants with early syphilis infection | 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 | Over 18 months of follow-up at quarterly visits from the date of randomization |
| Acceptability of Intervention Measure |
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). |
| Measured every 6 months over 18 months of follow-up from the date of randomization |
| Feasibility of Intervention Measure | 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). | Measured every 6 months over 18 months of follow-up from the date of randomization |
| Adverse events | Number of adverse events, including social harms, reported by participants or study staff at each study visit | Over 18 months of follow-up at quarterly visits from the date of randomization |
| University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa | Recruiting | Mombasa | Kenya |
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| TRANSFORM Clinic | Recruiting | Nairobi | Kenya |
|
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D016870 | Neisseriaceae Infections |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |