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

NCT03897725 | Withdrawn

• 1 other identifier: 000523914
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Behavior; HIV/AIDS; PrEP

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Telehealth Intervention

EXPERIMENTAL

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.

Other: Telehealth Coaching

Routine Care

NO INTERVENTION

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.

Interventions

Telehealth Coaching OTHER

Telehealth coaching to promote adherence

Telehealth Intervention

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females between 15 to 21 years old
• Established patients at the Adolescent Health Center
• HIV negative

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Gilead Sciences: collaborator

Study Sites (1)

William A. Daniel Adolescent Health Center

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tina Simpson, MD

  University of Alabama at Birminghahm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: December 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: To be determined
• Access Criteria: To be determined

Locations

US (1)