Gonorrhea MalePhase 4NCT06468462

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

A Phase 4 study testing WHO-recommended periodic presumptive treatment and Doxycycline post-exposure prophylaxis in people with Gonorrhea Male and Chlamydia (Male), run by University of Washington at 3 sites in Kenya.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 29 years, men onlyHealthy volunteers can take part
Conditions the study is for: Gonorrhea Male, Chlamydia (Male), Syphilis Male
What is being tested?: WHO-recommended periodic presumptive treatment and Doxycycline post-exposure prophylaxis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,900 participants
Where: 3 sitesKenya
Study dates: 29 Oct 2025to 30 Apr 2029
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 29 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

3 sites in 1 country.

Kenya3 sites

Anza Mapema Clinic
Kisumu
University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa
Mombasa
TRANSFORM Clinic
Nairobi

Other trials in Kenya

About this study

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

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.

Read the detailed description

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.

Conditions: Gonorrhea Male, Chlamydia (Male), Syphilis Male
Being tested: WHO-recommended periodic presumptive treatment, Doxycycline post-exposure prophylaxis
Keywords: gonorrhea, chlamydia, syphilis
Medical subject headings: Chlamydia Infections, Gonorrhea, Syphilis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WHO-recommended periodic presumptive treatmentDrug
Also called WHO PPT
400 mg po cefixime plus 1 gram azithromycin po under direct observation
Doxycycline post-exposure prophylaxisDrug
Also called doxyPEP
200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily

Study groups in NCT06468462
Study group	Role	What they receive
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. Receives: Drug: WHO-recommended periodic presumptive treatment
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. Receives: Drug: Doxycycline post-exposure prophylaxis
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Over 18 months of follow-up at quarterly visits from the date of randomization

Secondary outcomes (3)

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.
Measured: Over 18 months of follow-up at quarterly visits from the date of randomization
Number of participants with Chlamydia trachomatis infection
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.
Measured: 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
Measured: Over 18 months of follow-up at quarterly visits from the date of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 202530 Apr 2029

First posted21 Jun 2024
Study start29 Oct 2025
Primary completion31 Oct 2028 (estimated)
Study completion30 Apr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gonorrhea MaleStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 2,900 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06468462
Sponsor's protocol ID: STUDY00018588
Other IDs: 1R01AI179838-01
Status last verified: Jul 2026
First submitted: 1 Jun 2024
Last updated: 2 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 41873979
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.
PubMed 41494183

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: WHO-recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for STI Control Among Cisgender Men Who Have Sex With Men in Kenya
ClinicalTrials.gov ID: NCT06468462
Acronym / sponsor ID: STUDY00018588
Conditions: Gonorrhea Male, Chlamydia (Male), Syphilis Male
Keywords: gonorrhea, chlamydia, syphilis
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2,900 participants (estimated)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Aurum Institute, Nyanza Reproductive Health Society, National Institute of Allergy and Infectious Diseases (NIAID), Partners for Health & Development in Africa
Study start: 29 Oct 2025 (actual)
Primary completion: 31 Oct 2028 (estimated)
Study completion: 30 Apr 2029 (estimated)
First posted: 21 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
WHO-recommended periodic presumptive treatment	Active comparator	Drug: WHO-recommended periodic presumptive treatmentParticipants 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 comparator	Drug: Doxycycline post-exposure prophylaxisParticipants 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 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.

Who may qualify

Ages: 18 to 29 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WHO-recommended periodic presumptive treatmentAlso: WHO PPT400 mg po cefixime plus 1 gram azithromycin po under direct observation	Drug	WHO-recommended periodic presumptive treatment
Doxycycline post-exposure prophylaxisAlso: doxyPEP200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily	Drug	Doxycycline post-exposure prophylaxis

Primary outcome

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.

3 secondary outcomes

Number of participants with Neisseria gonorrhea infection
Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization
Number of participants with Chlamydia trachomatis infection
Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization
Number of participants with early syphilis infection
Time frame: Over 18 months of follow-up at quarterly visits from the date of randomization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Derived from this study: PubMed 41873979Ochieng 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.
Derived from this study: PubMed 41494183Graham 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.
Individual participant dataSharing planned: Yes. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan M Graham, MD, PhD, MPH principal investigator

University of Washington

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06468462, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.