Sexually Transmitted Infections
Conditions
Interventions
Doxycycline DOT
Sponsors
University of Washington
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Willing and able to give written informed consent 2) Age 18-30 years 3) Female sex at birth 4) HIV-seronegative, according to national HIV testing algorithm 5) Has a current prescription for PrEP, according to the national guidelines of Kenya 6) Able and willing to adhere to DOT dosing schedules
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of completed doses of weekly doxycycline DOT | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety: Safety assessment will be measured in both arms: serious adverse events (SAEs), related all AEs and discontinuations (in the dPEP arm only), and a standardized symptom assessment for doxycycline-specific side effects (e.g., nausea, pill esophagitis, photosensitivity, vaginal candidiasis). • Acceptability: Longitudinal change in survey responses • Incidence of C. trachomatis based on NAAT | — |
Countries
Kenya
Contacts
Public ContactFelix Mogaka
Co Investigator
Outcome results
None listed