Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
Not Applicable
Withdrawn
- Conditions
- Adolescent BehaviorHIV/AIDSPrEP
- Registration Number
- NCT03897725
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
William A. Daniel Adolescent Health Center
🇺🇸Birmingham, Alabama, United States
William A. Daniel Adolescent Health Center🇺🇸Birmingham, Alabama, United States