Evaluation of the feasibility, acceptability, and effectiveness of TelePrEP for at-risk youth in Colorado

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Description

This study aims to assess whether PrEP delivery via a telehealth (termed TelePrEP throughout) approach supports persistence and retention on oral PrEP for young people and identify barriers and facilitators of TelePrEP for youth. The proposed research will address the critical need to identify modes of care that better engage youth at risk for HIV while concurrently evaluating the impact and health outcomes of PrEP in youth and exploring racial/ethnic and other health disparities that contribute to lack of PrEP access for the highest risk youth in Colorado..

Details
Age

Child to Adult

Eligibility

1. HIV negative 2. Eligible for PrEP using emtricitabine (F)/tenofovir alafenamide (TAF) (F/TAF) (brand name Descovy) based on current CDC guidance 3. Consents to TelePrEP visits 4. Consents to study participation 5... Age 14 to <25 years 6. Willing to use current insurance coverage for clinic and laboratory services OR willing to be assisted to obtain insurance coverage OR eligible for other Children&#8217;s Hospital Colorado coverage such as Title X funds or charity care.Inclusion criteria is as follows: 1. HIV negative a. We will follow CDC Clinical Practice Guidelines for PrEP 2021 recommendations for HIV testing prior to PrEP, including: i. Laboratory-based serum antigen/antibody test OR ii. Rapid, point-of-care, FDA-approved, fingerstick blood test 2. Eligible for PrEP using emtricitabine (F)/tenofovir alafenamide (TAF) (F/TAF) (brand name Descovy) based on current CDC guidance a. F/TAF for PrEP is indicated in at-risk adults and adolescents (>35kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. Relevant PrEP indications for F/TAF use include any person assigned male at birth without acute or established HIV infection, who 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 STI. 3. Consents to TelePrEP visits 4. Consents to study participation 5. Age 14 to <25 years 6. Willing to use current insurance coverage for clinic and laboratory services OR willing to be assisted to obtain insurance coverage OR eligible for other Children’s Hospital Colorado coverage such as Title X funds or charity care. Exclusion criteria is as follows: 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)

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Lisa Abuogi

Lisa Abuogi

Study ID

Protocol Number: 22-0588

More information available at ClinicalTrials.gov: NCT02585960

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