Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu, Kenya

Phase 4

Recruiting

• Conditions: HIV Infections; STI

• Registration Number: NCT06582966
• Lead Sponsor: University of Washington

Brief Summary

The first study of doxycycline postexposure prophylaxis for cisgender women did not reduce incident STIs likely due to low use of doxycycline. We will conduct a pilot study of once-weekly doxyxycline to prevent bacterial STIs among Kenyan cisgender women using PrEP for HIV prevention.

Detailed Description

A study evaluating doxycycline prophylaxis to prevent sexually transmitted infections (STIs) in PrEP-taking African women, who are a priority population for STI prevention, given their high risk and engagement in longitudinal prevention services. The primary study objective is to assess the acceptability of once weekly doxycycline prophylaxis and assess persistence in once weekly doxycycline delivered as directly observed therapy (DOT). STI prophylaxis carries substantial potential benefits but also important potential risks, and we have framed our work as capturing key data to inform this question. We hypothesize that weekly doxycycline will substantially reduce the incidence of curable STIs, particularly C. trachomatis, the most common bacterial STI and the one responsible for greatest morbidity.

Our secondary study objectives are to evaluate the impact on incidence rate of STIs in women given once-weekly doxycycline DOT in comparison with data collected among participants assigned to received standard of care in recently completed dPEP Kenya study as well as to assess tolerability of once weekly doxycycline prophylaxis. We will collect samples for future doxycycline hair drug level testing, antibiotic resistance testing, and microbiome evaluation.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-08-13
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Willing and able to give written informed consent
2. Age 18-30 years
3. Female sex assigned at birth
4. HIV-seronegative, according to national HIV testing algorithm
5. Has a current prescription for PrEP, > 1 month, according to the national guidelines of Kenya

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
doxyPEP DOT adherence	6 months	Confirmation of weekly doxyPEP DOT dosing each week will be recorded on weekly CRFs and quarterly surveys on acceptability will be completed.