Phase 4
N=60
Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu, Kenya
STI
Bottom Line
View on ClinicalTrials.gov: NCT06582966 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: doxyPEP DOT Adherence — 1417 Doses
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Doxycycline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY doxyPEP DOT Adherence |
1417 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06582966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.