HIV/AIDS
Conditions
Interventions
No SMS reminders
Sponsors
University of Washington
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Female · HIV-uninfected (as determined by Kenya national testing algorithms) · Age 18-24 years · Wanting to start PrEP with an initial recommendation of 6 months of use · Clinically safe to receive PrEP, in accordance with CDC guidelines: Creatinine clearance >60 mL/min Not infected with hepatitis B No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study · Sexually active (defined as vaginal or anal sex) within the last 3 months · At high risk for HIV infection based on a score of >5 or being in an HIV serodiscordant relationship · Not pregnant · Owns a personal cell phone (not shared) compatible with the technology used in the study and the ability to charge it · Intending to stay in the area for at least the next year
Exclusion criteria
Exclusion criteria: Unable to provide consent Breast-feeding (Truvada is not currently approved for use during breast-feeding) Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Wisepill adherence (enacted adherence and persistence) ?Tenofovir concentration as a marker of adherence ?Feasibility of Wisepill monitoring and SMS reminders ?Acceptability of Wisepill monitoring and SMS reminders ?Ease of use, health care associated costs, and cost-effectiveness of Wisepill monitoring and SMS reminders ?Validity of Wisepill monitoring compared to tenofovir concentration in DBS | — |
Secondary
| Measure | Time frame |
|---|---|
| Completion of PrEP refills | — |
Countries
Kenya
Contacts
Public ContactCatherine Kiptinness
Study Coordinator
Outcome results
None listed