RECRUITING

TelePrEP for At-risk Youth in Colorado

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Youth represent the largest proportion of new HIV infections in Colorado, reflective of their inadequate access and uptake of pre-exposure prophylaxis(PrEP)for HIV prevention. Colorado's 2019 HIV/AIDS Prevention Program state-wide review of PrEP barriers showed PrEP eligible individuals do not access PrEP services due to lack of interest, not wanting referral to a navigator, and low estimation of HIV risk. The overall goal is to provide youth at higher risk for HIV with an effective youth informed telemedicine delivery of PrEP (TelePrEP) that addresses PrEP barriers and contributes to ending the HIV epidemic in Colorado. The primary objective will be proportion of youth retained on PrEP 12 months after initiation. The hypotheses are that a TelePrEP model for youth will be acceptable and feasible and will result in successful initiation, persistence and retention on oral PrEP.

Official Title

Evaluation of the Feasibility, Acceptability, and Effectiveness of TelePrEP for At-risk Youth in Colorado

Quick Facts

Study Start:2023-04-18
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05520905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 24 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * HIV negative
  2. * Eligible for PrEP using emtricitabine (F)/tenofovir alafenamide (TAF) (F/TAF) (brand name Descovy) based on current CDC guidance
  3. * assigned male at birth
  4. * has had male sex partners in the past 6 months (and not in a monogamous partnership with a recently tested, HIV-negative man) and
  5. * either any sex without a condom in the past 6 months or
  6. * a bacterial sexually transmitted infection
  7. * Consents to TelePrEPvisits
  8. * Willing to use current insurance coverage for clinic and laboratory services OR willing to be assisted to obtain insurance coverage OR eligible for other coverage such as Title X funds or charity care
  1. * HIV-infection or concern for acute HIV infection until ruled out
  2. * Pregnancy
  3. * Persons at risk through receptive vaginal sex including cisgender women and transgender men (persons assigned female sex at birth)
  4. * Persons with only injection drug indications for PrEP without sexual risk indications outlined in inclusion criteria

Contacts and Locations

Study Contact

Alex Limas
CONTACT
720-777-2604
alexander.limas@childrenscolorado.org
Lisa Abuogi
CONTACT
lisa.abuogi@ucdenver.edu

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-18
Study Completion Date2025-04

Study Record Updates

Study Start Date2023-04-18
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • youth
  • telemedicine
  • telehealth
  • HIV
  • prevention

Additional Relevant MeSH Terms

  • Hiv