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

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

Study Overview

• Status: Completed
• Conditions: STI
• Intervention / Treatment: Drug: Doxycycline

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. Researchers 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.

Researchers' 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. Researchers will collect samples for future doxycycline hair drug level testing, antibiotic resistance testing, and microbiome evaluation.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute -KEMRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DoxyDOT single arm; Open label, single-arm, pilot study of 60 cisgender women taking HIV PrEP in Kisumu, Kenya will be given doxycycline 200 mg orally once weekly with clinical follow-up including quarterly STI testing and treatment for six months.	Drug: Doxycycline; Open label, single-arm, pilot study of 60 cisgender women taking HIV PrEP in Kisumu, Kenya will be given doxycycline 200 mg orally once weekly with clinical follow-up including quarterly STI testing and treatment for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
doxyPEP DOT Adherence	Confirmation of weekly doxyPEP DOT dosing each week will be recorded on weekly CRFs and quarterly surveys on acceptability will be completed.	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Elizabeth Bukusi, PhD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Actual): May 27, 2025
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: STI
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Naphthacenes; Tetracyclines; Doxycycline
• Other Study ID Numbers: STUDY00019944; 5R01AI145971-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No