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CompletedNCT05528653e-PrEPUpdated Sep 23, 2025

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

A Phase 4 interventional study of Descovy in HIV Prevention, sponsored by Vivent Health. Completed at 3 sites in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Vivent Health · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • HIV Prevention

Keywords

  • HIV
03

In context

Lead sponsor

Vivent Health is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. HIV positive
  2. If greater and equal to 50 years of age and Renal Glomerular Filtration Rate (GFR) \<30 mg/g
  3. \<18 years of age
  4. No access to Internet or devise for telehealth
  5. Cis-gender Women
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Other
    Open Label Descovy

    Descovy for PrEP

    Drug: Descovy

Interventions

  • DrugDescovy

    HIV infection pre-exposure prophylaxis

06

What researchers measure

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.

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

    Time frame: 18 months

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.

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

    Time frame: 18 months

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

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

    Time frame: 18 months

07

Study locations

3 sites
  • Vivent Health
    Denver, Colorado 80245, United States
  • Vivent Health
    St Louis, Missouri 63103, United States
  • Viventh Health
    Milwaukee, Wisconsin 53203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05528653
Lead sponsor
Vivent Health
Collaborators
Gilead Sciences
Responsible party
Cindy Firnhaber (Principal Investigator, Vivent Health) — Principal investigator
First posted
Sep 6, 2022
Start date
Jul 19, 2022
Primary completion
Jul 31, 2024
Completion
Mar 21, 2025
Last update
Sep 23, 2025

Study contacts

Cindy Firnhaber, MD
principal investigator · Vivent Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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