TelePrEP for At-risk Youth in Colorado

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520905
• Other study ID #: 22-0588
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Alex Limas
• Phone: 720-777-2604
• Email: alexander.limas[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• TelePrEP
HIV pre-exposure prophylaxis delivered via telemedicine.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Uptake TelePrEP	Number (median; interquartile range) of TelePrEP visits carried out successfully with youth PrEP users by referral or initiation setting	48 weeks
Other	TelePrEP visit rate	Number (median; interquartile range) of TelePrEP visits per patient in 12 month period vs. in-person visits per participant and associate patients demographics related to higher number of TelePrEP visits.	48 weeks
Other	TelePrEP Satisfaction	PrEP user and provider satisfaction with TelePrEP services.	48 weeks
Primary	Retention	Retention on PrEP at week 48. Retention in PrEP care 12 months after initiation as defined by either PrEP clinic visit (telehealth or in-person) or prescription refill.	48 weeks
Secondary	TelePrEP Feasibility	Feasibility will be measured by 1) proportion of those screened and eligible who are initiated on PrEP, 2) persistence (time to first discontinuation), and 3) survey responses from participants identifying barriers and facilitators of TelePrEP (satisfaction survey).	48 weeks
Secondary	TelePrEP Acceptability	Acceptability will be measured by 1) proportion who obtain PrEP services via TelePrEPfor at least 2 visits in a 12 month period and 2) electronic questionnaire responses from youth screening for PrEP at study enrollment as well as satisfaction surveys	48 weeks