Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407778358273 Date of Approval: 24/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title WHO-Recommended Periodic Presumptive Treatment versus Doxycycline Post-Exposure Prophylaxis for STI Control among Cisgender Men Who Have Sex with Men in Kenya
Official scientific title WHO-Recommended Periodic Presumptive Treatment versus Doxycycline Post-Exposure Prophylaxis for STI Control among Cisgender Men Who Have Sex with Men in Kenya
Brief summary describing the background and objectives of the trial 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied bacterial sexually transmitted infections including gonorrhea, chlamydia, and syphilis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2024
Actual trial start date
Anticipated date of last follow up 31/01/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 2900
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT06468462 ClinicalTrials.gov
STUDY00018588 University of Washington Human Subjects Division
SERU4962 Kenya Medical Research Institute Scientific and Ethics Review Unit
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard care 400 mg po cefixime plus 1 gram po azithromycin stat under direct observation if syndrome present 18 months of follow up Participants assigned to the standard care arm will receive screening for STI symptoms at every scheduled visit and syndromic treatment, if indicated, 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. Standard care also includes notification of partners who may have been exposed, with expedited partner treatment to those in ongoing relationships with the index patient. 580 Active-Treatment of Control Group
Experimental Group Periodic presumptive treatment 400 mg po cefixime plus 1 gram azithromycin po under direct observation eligibility assessed quarterly over 18 months of follow-up 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. 1160
Experimental Group DoxyPEP 200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily 18 months of follow-up Participants assigned to the doxyPEP arm will be provided with a 30-day supply of doxycycline hyclate at each quarterly visit withrefills as needed. They will be given 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. 1160
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 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 • 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) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 29 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/07/2024 Kenya Medical Research Institute Scientific and Ethical Review Unit
Ethics Committee Address
Street address City Postal code Country
PO Box 54840 00200 Off Mbgathi Road Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/09/2023 University of Washington Human Subjects Division
Ethics Committee Address
Street address City Postal code Country
4333 Brooklyn Avenue NE, Box 359470 Seattle, WA 98195 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of participants with NG, CT, or early syphilis infection (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. At each quarterly visit through 18 months
Secondary Outcome Number of participants with an Aptima test on a pooled specimen (throat, rectal, and urine) positive for Neisseria gonorrhea infection will be determined at each visit. At each quarterly visit through 18 months
Secondary Outcome The number of participants with an Aptima test on a pooled specimen (throat, rectal, and urine) positive for Chlamydia trachomatis will be determined at each visit. At each quarterly visit through 18 months
Secondary Outcome 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. At each quarterly visit through 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nyanza Reproductive Health Society United Mall, PO Box 1764 Kisumu Kenya
Partners for Health and Development in Africa 5th Ngong Ave Suites, 7th Floor Room 7-9, PO Box 3737-00506 Nairobi Kenya
University of Nairobi Ganjoni Health Centre Mnazi Mmoja Road Mombasa 80103 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Allergy and Infectious Diseases 5601 Fishers Lane, MSC 9806 Bethesda MD 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Allergy and Infectious Diseases 5601 Fishers Lane, MSC 9806 Bethesda MD 20982 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
University of Washington Office of Sponsored Programs 4333 Brooklyn Ave NE Seattle WA 98195 United States of America
The Aurum Institute The Ridge, 29 Queens Road Parktown 2193 ZAF South Africa
Nyanza Reproductive Health Society United Mall, PO Box 1764 Kisumu Kenya
Partners for Health and Development in Africa 5th Ngong Ave Suites, 7th Floor Room 7-9, PO Box 3737-00506 Nairobi Kenya
University of Nairobi Ganjoni Health Centre Mnazi Mmoja Road Mombasa Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Susan Graham grahamsm@uw.edu +12063510414 325 Ninth Avenue, Box 359909
City Postal code Country Position/Affiliation
Seattle WA 98104 United States of America University of Washington
Role Name Email Phone Street address
Public Enquiries Fatma MwidadiKosgei fmwidadi@uw.edu +254735451225 University of Nairobi Ganjoni Health Center, Mnazi Mmoja Road
City Postal code Country Position/Affiliation
Mombasa Kenya Administrator for University of Washington University of Nairobi Research Center
Role Name Email Phone Street address
Scientific Enquiries Susan Graham grahamsm@uw.edu +12063510414 325 Ninth Avenue, Box 359909
City Postal code Country Position/Affiliation
Seattle WA 98104 United States of America University of Washington
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This project will produce sociodemographic, behavioral, clinical and laboratory data obtained from surveys and clinical specimens collected from study participants. Data collection will be performed at three clinical sites in Kenya with cisgender men who have sex with men. Data will be collected from 2,900 participants: 1,160 participants in each intervention group and 580 in the control group, with quarterly follow-up visits starting at baseline through 18 months post-enrolment. In addition to data directly obtained from participants, we will collect data on costs of each of the two interventions tested. De-identified datasets and modeling inputs will be made available at the trial's completion, and datasets used for statistical analysis will be made available in the Harvard Dataverse as manuscripts are published. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol De-identified IPD will be shared as required by the funder will be shared within 12 months of study completion. 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.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
clinicaltrials.gov No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information