NCT05520905

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

August 26, 2022

Last Update Submit

May 7, 2024

Conditions

Hiv

Keywords

youthtelemedicinetelehealthHIVprevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • TelePrEP Feasibility

    48 weeks

  • TelePrEP Acceptability

    48 weeks

Other Outcomes (3)

  • Uptake TelePrEP

    48 weeks

  • TelePrEP visit rate

    48 weeks

  • TelePrEP Satisfaction

    48 weeks

Study Arms (1)

Telemedicine for pre-exposure prophylaxis of HIV

EXPERIMENTAL

1. We will identify youth potentially eligibile for PrEP using tenfovir alefenamide/emtricitabine (TAF/FTC). 2. Eligible youth will be contacted for rapid (same day) consenting and enrollment. 3. Participants who consent to the study will undergo a PrEP initiation visit either the same day or within two weeks with a provider. The initial visit may be in-person or via Telemedicine. 4. TelePrEP visits may be carried out in the setting of the participant's choosing and may include home or at a community organization. 5. Recommended laboratory testing will be arranged as part of the PrEP initiation visit. HIV testing will be carried out as well as Centers for Disease Control and Prevention (CDC)-recommended laboratory testing will be obtained. 6. TelePrEP(or in-person visits as needed) will be conducted by a skilled multidisciplinary team one month after initiation and then every three months.

Other: TelePrEP

Interventions

TelePrEPOTHER

HIV pre-exposure prophylaxis delivered via telemedicine.

Telemedicine for pre-exposure prophylaxis of HIV

Eligibility Criteria

Age14 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Alex Limas

CONTACT

720-777-2604alexander.limas@childrenscolorado.org

Lisa Abuogi

CONTACT

lisa.abuogi@ucdenver.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 30, 2022

Study Start

April 18, 2023

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)