Hiv
Conditions
Keywords
youth, telemedicine, telehealth, HIV, prevention
Brief 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.
Interventions
OTHERTelePrEP
HIV pre-exposure prophylaxis delivered via telemedicine.
Sponsors
Gilead Sciences
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
14 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 48 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TelePrEP Feasibility | 48 weeks | 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). |
| TelePrEP Acceptability | 48 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Uptake TelePrEP | 48 weeks | Number (median; interquartile range) of TelePrEP visits carried out successfully with youth PrEP users by referral or initiation setting |
| TelePrEP visit rate | 48 weeks | 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. |
| TelePrEP Satisfaction | 48 weeks | PrEP user and provider satisfaction with TelePrEP services. |
Countries
United States
Contacts
Primary ContactAlex Limas
Backup ContactLisa Abuogi
Outcome results
None listed