Telemedicine for HIV prevention in at-risk youth in Colorado
Evaluation of the Feasibility, Acceptability, and Effectiveness of TelePrEP for At-risk Youth in Colorado
This study is testing a telemedicine program that provides HIV prevention medication to at-risk youth in Colorado to see if it helps them stay on the treatment for a full year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 14 Years to 24 Years |
| Sex | Male |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05520905 on ClinicalTrials.gov |
What this trial studies
This initiative aims to provide telemedicine-based pre-exposure prophylaxis (PrEP) to youth at higher risk for HIV in Colorado. It addresses barriers to accessing PrEP services, such as lack of interest and low perception of HIV risk. The primary goal is to retain youth on PrEP for 12 months after initiation, with the expectation that this TelePrEP model will be both acceptable and effective in promoting adherence to HIV prevention strategies. The study will evaluate the feasibility and success of this approach in improving PrEP uptake among eligible youth.
Who should consider this trial
Good fit: Ideal candidates are HIV-negative youth assigned male at birth who have had male sex partners and meet specific risk criteria for PrEP eligibility.
Not a fit: Patients who are HIV-positive, pregnant, or at risk through receptive vaginal sex may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly increase PrEP access and retention among at-risk youth, ultimately reducing new HIV infections.
How similar studies have performed: Other studies have shown promising results with telehealth approaches for HIV prevention, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Alex Limas
- Email: alexander.limas@childrenscolorado.org
- Phone: 720-777-2604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.