TelePrEP for At-risk Youth in Colorado

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Hiv

Treatments: Other: TelePrEP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05520905

22-0588

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 14 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)
• Persons with only injection drug indications for PrEP without sexual risk indications outlined in inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Telemedicine for pre-exposure prophylaxis of HIV

Experimental group

Description:

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.

Treatment:

Other: TelePrEP