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OpenTrials
Completed

NCT Number: NCT05528653

Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"

To evaluate if utilizing Telehealth medicine for access to HIV PrEP will engage more Black and Latino Men who have sex with Men (MSM)

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Vivent Health, Denver, Colorado, United States

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About this study

The goal of this study is to determine whether incorporating a telehealth model that allows for same-day appointments for PrEP delivery with the support of navigation leads to increased uptake and persistence of PrEP in young MSM/transgender of color and individuals in rural communities that have disproportionately not used PrEP. The investigators will accomplish this by using an effectiveness-hybrid design that will allow us to both evaluate the interventions impact on relevant clinical outcomes as well as the effectiveness of the implementation strategy. Our hypothesis is that by removing some of the barriers to care such as transportation, childcare, work schedule and potentially stigma with repeated clinic visits, the investigators will increase the uptake and persistence of PrEP amongst communities who historically have had many barriers to care and have not started PrEP.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV negative on any FDA approved HIV test within 10 days of starting PrEP 18 years and older
  • No medical or mental health comorbidity that would preclude participating in a clinical study as deemed by the study investigator
  • Able to understand and sign consent in English or with other language interpreter
  • Able to stay in the state catchment area of the license health care provider
  • No use of PrEP for more than 30 days in the last year

Exclusion criteria

  • HIV positive
  • If greater and equal to 50 years of age and Renal Glomerular Filtration Rate (GFR) <30 mg/g
  • <18 years of age
  • No access to Internet or devise for telehealth
  • Cis-gender Women

Treatment and study plan

Descovy

Drug

HIV infection pre-exposure prophylaxis

Primary outcomes

  1. : To increase the number and proportion of individuals who start PrEP who have been under-represented in PrEP uptake including those who identify as Black and/or Latino MSM.

    Time frame: 18 months

    Offer PrEP care via tele-health to reduce obstacles that clients have in coming to clinic.

Secondary outcomes

  1. To increase the number and proportion of individuals who are still taking PrEP and engaged in care at the end of 6 months by 30% and remain HIV negative including those who identify as Black and/or Latino MSM.

    Time frame: 18 months

    Facilitate maintenance of care by offering Tele-health for initial and ongoing PrEP care to reduce social and structural barriers.

  2. To assess the acceptability and implementation of the intervention by both patients and clinic staff.

    Time frame: 18 months

    Obtain quantitative feedback via survey about services provided via Telehealth from patients and clinic staff.

Sponsors and collaborators

Lead sponsor

Vivent Health

Other

Collaborators

  • Gilead Sciences

Registry information

Acronym: e-PrEP

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Sep 6, 2022
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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