HIV/AIDS
Conditions
Interventions
Standard of care
Sponsors
Massachusetts General Hospital Harvard Medical School
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: o Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who have been pregnant) per Kenyan national guidelines [39] or 16-17 year-olds with parental consent o Initiating PrEP (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status, normal renal function, and lack of Hepatitis B infection) o Residence in the Kisumu region (maximum of 20 km from our study offices at RCTP) o Phone ownership o Ability to understand KiSwahili, DhoLuo, and/or English
Exclusion criteria
Exclusion criteria: • Inability to provide informed consent (e.g., intoxication, mental disability)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preliminary impact on PrEP adherence and program retention at 6 months. PrEP adherence will be assessed primarily by DBS for tenofovir diphosphate (TFV-DP) concentration. The TFV-DP concentration will provide an estimate of doses taken over the prior 3 months. Retention will be assessed by kit receipt in the intervention arm and clinic attendance per clinic records in the control arm at Month 6. Potential influencing and mediating socio-behavioral factors will be explored. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will assess the following: • Self-reported PrEP adherence at Months 1, 3, and 6 (intervention arm) and Month 6 (control arm). We will use the 3-item scale developed by Wilson et al, which involves different recall tasks (frequency, percent, and rating of adherence) over the prior 30 days. • PrEP persistence over the 6-month period. • Rates of STI testing at Months 1, 3, and 6 • Rates of pregnancy test and contraception pick up at Months 1, 3, and 6. • Cost estimates. | — |
Countries
Kenya
Contacts
Public ContactKevin Kamolloh
Investigator
Outcome results
None listed