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

NCT06582966 | Completed Phase 4 Results

• 2 other identifiers: STUDY000199445R01AI145971-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

STI

Keywords

STI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DoxyDOT single arm

OTHER

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

Interventions

Doxycycline 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.

DoxyDOT single arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: cis-gender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant
• Breastfeeding a child
• Allergy to tetracycline class
• 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.
• Active, clinically significant medical or psychiatric conditions that would interfere with study participation, at the discretion of the site investigator or designee.
• Prior enrollment in The dPEP Kenya Study

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Kenya Medical Research Institute -KEMRI

Kisumu, Kenya

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Jenell Stewart, DO, MPH
• Organization: University of Minnesota, Hennepin Healthcare

jenell.stewart@hcmed.org

(612)8735271

Study Officials

• Elizabeth Bukusi, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor: Global Health

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: August 13, 2024
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Locations

KE (1)