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.: PACTR202401619811584 Date of Approval: 23/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DoxyDOT Study
Official scientific title Weekly doxycycline DOT for STI prevention among cisgender women taking HIV PrEP in Kisumu, Kenya
Brief summary describing the background and objectives of the trial African women face disproportionate risk from overlapping epidemics of HIV and bacterial sexually transmitted infections (STIs). HIV pre-exposure prophylaxis (PrEP) is emerging into a global context with unprecedented rates of curable STIs. Post-exposure prophylaxis using the antibiotic doxycycline has been proposed as a novel STI prevention strategy. The first study of doxycycline postexposure prophylaxis for cisgender women did not reduce incident STIs likely due to low use of doxycycline. The overarching goal is to assess acceptability and adherence to once-weekly doxycycline dosing to prevent STIs. We will conduct a pilot study of once-weekly doxycycline to prevent bacterial STIs among Kenyan cisgender women using PrEP for HIV prevention. Approximately 50 (up to 60) sexually active, cisgender women ages 18-30 years will be enrolled in this study and followed for six months. Participants will receive doxycycline once-weekly dose as directly observed therapy (DOT). All participants will complete STI testing (chlamydia, gonorrhea, and syphilis)at enrollment, month-three and month-six. Prior to initiating treatment and at exit visit, all participants will have samples collected for future microbiome and resistance testing. Hair samples will be collected at follow-up visits for future pharmacokinetic model development. The primary endpoint is percentage of completed weekly DOT doxycycline doses. Secondary endpoint is quarterly incident rate of Chlamydia trachomatis compared with quarterly incidence among participants assigned to standard of care in the dPEP Kenya Study. Primary Study Objectives: 1. Assess the acceptability of once weekly doxycycline prophylaxis 2. Assess persistence in once weekly doxycycline DOT Secondary Study Objectives: 1. Evaluate incidence rate of STIs in women given once-weekly doxycycline DOT 2. Assess the safety and tolerability of once weekly doxycycline prophylaxis 3. Collect samples for future doxycycline hair drug level pharm
Type of trial Non-Randomised
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 Sexually Transmitted Infections
Purpose of the trial Prevention
Anticipated trial start date 01/04/2024
Actual trial start date
Anticipated date of last follow up 01/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Doxycycline DOT Two 100mg doxycycline capsules once weekly for six months. Six months Generic immediate release doxycycline hyclate 100 mg capsules will be provided by the study to participants randomized to doxycycline DOT and will take two capsules once weekly for six months. Doxycycline hyclate is a standard formulation of doxycycline that is widely available internationally and FDA approved for the treatment of a number of infectious conditions. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Willing and able to give written informed consent 2) Age 18-30 years 3) Female sex at birth 4) HIV-seronegative, according to national HIV testing algorithm 5) Has a current prescription for PrEP, according to the national guidelines of Kenya 6) Able and willing to adhere to DOT dosing schedules 1) Pregnant 2) Breastfeeding a child 3) Allergy to tetracycline class 4) Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, phenytoin, and warfarin. 5) Active, clinically significant medical or psychiatric conditions that would interfere with study participation, at the discretion of the site investigator or designee. 6) Prior enrollment in The dPEP Kenya Study Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 30 Year(s) Female
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
No 15/01/2024 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
KEMRI HQ Mbagathi Way Kisumu 40100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of completed doses of weekly doxycycline DOT Weekly for six months
Secondary Outcome • Safety: Safety assessment will be measured in both arms: serious adverse events (SAEs), related all AEs and discontinuations (in the dPEP arm only), and a standardized symptom assessment for doxycycline-specific side effects (e.g., nausea, pill esophagitis, photosensitivity, vaginal candidiasis). • Acceptability: Longitudinal change in survey responses • Incidence of C. trachomatis based on NAAT Month 1, Month 3 and Month 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI RCTP Lumumba Subcounty Hospital Ondiek Highway Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
US National Institutes of Health National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892 Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington Hans Rosling Center, 3980 15th Ave NE, Seattle, WA 98105, United States Seattle 98105 United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Bukusi ebukusi@kemri.go.ke +254733617503 Mbagathi Way
City Postal code Country Position/Affiliation
Nairobi Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Felix Mogaka fmogaka@kemri-rctp.org +254723686156 Ondiek Highway
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Co Investigator
Role Name Email Phone Street address
Scientific Enquiries Jenell Stewart jenell.stewart@hcmed.org +16128735300 825 8th St S, Minneapolis, MN 55404, United States
City Postal code Country Position/Affiliation
Minneapolis United States of America Co investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be available.The Clinical study report will be available for researchers who provide a methodologically sound proposal immediately after study publication.This data shall only be used to achieve aims in the approved protocols. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan Within 12 months of the study completion Controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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