Evaluating The Acceptability and Uptake of PrEP for Adolescent Women in The Deep South

University of Alabama at Birmingham1 site in 1 countryDecember 1, 2020

ConditionsAdolescent Behavior HIV/AIDS PrEP

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adolescent Behavior
Sponsor: University of Alabama at Birmingham
Locations: 1
Primary Endpoint: Adherence to PrEP
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2020

End Date

September 30, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Tina Y Simpson

Professor

University of Alabama at Birmingham

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.

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