Evaluating The Acceptability and Uptake of PrEP for Adolescent Women in The Deep South
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Adherence to PrEP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 21 Years (Child, Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Telehealth Intervention
Study participants will be randomized into either the control or experimental group. Participants in the intervention group will receive routine care which will follow the schedule from previous adolescent PrEP studies where participants are recommended to follow up at 4, 8, and 12 weeks and then every 3 months following initiation of PrEP. This group will also receive SMS texting every 4 weeks between in-person visits (weeks 16, 20, 28,32, 40, 44) reminding them to pick up their medication. The experimental group will also be seen in follow up every month for the first 3 months and then spaced out to visits every 3 months. The SMS texting will occur every 4 weeks between in-person visits, the experimental group will also have 2 tele-health visits (which will be conducted within a participant's home using an app) that will occur every 4 weeks between each of the traditional in-person visits to provide more frequent monitoring and counseling regarding adherence.
Intervention: Telehealth Coaching (Other)
Routine Care
The control group will follow the schedule from previous adolescent PrEP studies where participants are recommended to follow up at 4, 8, and 12 weeks and then every 3 months following initiation of PrEP.
Outcomes
Primary Outcomes
Adherence to PrEP
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Tina Y Simpson
Professor
University of Alabama at Birmingham