Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
Adolescent Behavior, HIV/AIDS, PrEP
About this trial
This is an interventional prevention trial for Adolescent Behavior
Eligibility Criteria
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.
Sites / Locations
- William A. Daniel Adolescent Health Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Telehealth Intervention
Routine Care
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.
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.