RecruitingNot ApplicableNCT05520905

TelePrEP for At-risk Youth in Colorado

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


Sponsor

University of Colorado, Denver

Enrollment

100 participants

Start Date

Apr 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 14 YearsMax Age: 24 Years

Inclusion Criteria8

  • HIV negative
  • Eligible for PrEP using emtricitabine (F)/tenofovir alafenamide (TAF) (F/TAF) (brand name Descovy) based on current CDC guidance
  • assigned male at birth
  • has had male sex partners in the past 6 months (and not in a monogamous partnership with a recently tested, HIV-negative man) and
  • either any sex without a condom in the past 6 months or
  • a bacterial sexually transmitted infection
  • Consents to TelePrEPvisits
  • 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

Exclusion Criteria3

  • HIV-infection or concern for acute HIV infection until ruled out
  • Pregnancy
  • Persons at risk through receptive vaginal sex including cisgender women and transgender men (persons assigned female sex at birth)

Interventions

OTHERTelePrEP

HIV pre-exposure prophylaxis delivered via telemedicine.


Locations(1)

Children's Hospital Colorado

Aurora, Colorado, United States

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NCT05520905


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