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

NCT ID: NCT06582966

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

STI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Doxycyclin

Intervention Type: DRUG

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.

Interventions

Doxycyclin

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jared Baeten

Professor: Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jared Baeten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Kenya Medical Research Institute -KEMRI

Kisumu, , Kenya

Countries

Kenya

Other Identifiers

5R01AI145971-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00019944

Identifier Type: -

Identifier Source: org_study_id