Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
NCT ID: NCT03897725
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-12-01
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Telehealth Coaching
Telehealth coaching to promote adherence
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.
No interventions assigned to this group
Interventions
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Telehealth Coaching
Telehealth coaching to promote adherence
Eligibility Criteria
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Inclusion Criteria
* Established patients at the Adolescent Health Center
* HIV negative
Exclusion Criteria
* 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.
15 Years
21 Years
FEMALE
Yes
Sponsors
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Gilead Sciences
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
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Tina Y Simpson
Professor
Principal Investigators
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Tina Simpson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birminghahm
Locations
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William A. Daniel Adolescent Health Center
Birmingham, Alabama, United States
Countries
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Other Identifiers
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000523914
Identifier Type: -
Identifier Source: org_study_id