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NCT03897725 Clinical Trial

Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03897725
Other study ID # 000523914
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date September 30, 2022

Study information
Verified date November 2021
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 21 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Telehealth Coaching
Telehealth coaching to promote adherence

Locations
Country Name City State
United States William A. Daniel Adolescent Health Center Birmingham Alabama

Sponsors (2)
Lead Sponsor Collaborator
University of Alabama at Birmingham Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence to PrEP Retention of adolescent females in PrEP care (attendance at follow-up visits) and adherence to emtricitabine/tenofovir evidenced by dried blood spot sampling 1 year
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