Adolescent Behavior, HIV/AIDS, PrEP
Conditions
Brief summary
This project is designed to 1) develop a PrEP implementation plan for a general adolescent clinic. Investigators will develop a replicable implementation plan for providing PrEP to adolescents in a primary care setting; and 2) Determine the acceptability and preliminary effectiveness of a telehealth intervention to promote adherence in adolescents.
Interventions
OTHERTelehealth Coaching
Telehealth coaching to promote adherence
Sponsors
Gilead Sciences
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Females between 15 to 21 years old * Established patients at the Adolescent Health Center * HIV negative
Exclusion criteria
* HIV positive patients * patients weighing less than 35kg * patients with creatinine clearance \<60 ml/min * patients with documented osteopenia or osteoporosis or history of pathologic fractures * patients with previous allergic reactions to either emtricitabine or tenofovir * patients who are on post-exposure prophylaxis for HIV (they can become eligible after completion of therapy) * patients with hepatic impairment * For patients who become pregnant, they may be able to continue on PrEP after a discussion with their obstetrics/gynecology (OB/GYN) provider.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to PrEP | 1 year | Retention of adolescent females in PrEP care (attendance at follow-up visits) and adherence to emtricitabine/tenofovir evidenced by dried blood spot sampling |
Countries
United States
Outcome results
None listed