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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 14
Maximum Age: 24
Healthy Volunteers: t
View:

• 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

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Alex Limas
alexander.limas@childrenscolorado.org
720-777-2604
Backup
Lisa Abuogi
lisa.abuogi@ucdenver.edu
Time Frame
Start Date: 2023-04-18
Estimated Completion Date: 2025-04
Participants
Target number of participants: 100
Treatments
Experimental: Telemedicine for pre-exposure prophylaxis of HIV
1. We will identify youth potentially eligibile for PrEP using tenfovir alefenamide/emtricitabine (TAF/FTC).~2. Eligible youth will be contacted for rapid (same day) consenting and enrollment.~3. Participants who consent to the study will undergo a PrEP initiation visit either the same day or within two weeks with a provider. The initial visit may be in-person or via Telemedicine.~4. TelePrEP visits may be carried out in the setting of the participant's choosing and may include home or at a community organization.~5. Recommended laboratory testing will be arranged as part of the PrEP initiation visit. HIV testing will be carried out as well as Centers for Disease Control and Prevention (CDC)-recommended laboratory testing will be obtained.~6. TelePrEP(or in-person visits as needed) will be conducted by a skilled multidisciplinary team one month after initiation and then every three months.
Related Therapeutic Areas
Sponsors
Collaborators: Gilead Sciences
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov