HIV/AIDS
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: For HIV uninfected women - Age 16-25 o 16 and 17 year olds, where permissible by national regulations and local IRB approval - Able and willing to provide written informed consent - Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months) - HIV uninfected based on negative HIV rapid tests, on the date of enrollment
Exclusion criteria
Exclusion criteria: Not within the required age range Not willing to provide informed consent Not sexually active HIV infected
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of this project is to demonstrate feasibility of delivery of open-label PrEP to young women using three different delivery platforms. Thus, the principal justification for the sample size is inclusion of a sufficient number of HIV negative young women to indicate implementation feasibility, in a way that would inform normative guidance and public health recommendations. Importantly, in this way, the justification for the sample size is different than that of a comparative study (e.g., a randomized, placebo-controlled trial) ;Determine the persistence and patterns of PrEP use as they relate to contraceptive use, pregnancy and sexual exposure, and timing and reasons for PrEP discontinuation;Demonstrate PrEP delivery models for young women in family planning setting in Kisumu; HIV incidence in relationship to PrEP use, and HIV drug resistance among seroconverters on PrEP | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost, and cost-effectiveness of PrEP when delivered in public health clinics. | — |
Countries
Kenya
Contacts
Pharmacist