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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine for pre-exposure prophylaxis of HIV | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TelePrEP | Other | HIV pre-exposure prophylaxis delivered via telemedicine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| TelePrEP Acceptability |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake TelePrEP | Number (median; interquartile range) of TelePrEP visits carried out successfully with youth PrEP users by referral or initiation setting | 48 weeks |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Limas | Contact | 720-777-2604 | alexander.limas@childrenscolorado.org | |
| Lisa Abuogi | Contact | lisa.abuogi@ucdenver.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2026 | |
| Reset | May 28, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2026 | May 28, 2026 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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 |
| 48 weeks |
| TelePrEP Satisfaction | PrEP user and provider satisfaction with TelePrEP services. | 48 weeks |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |