NCT05528653

Brief 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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2022

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

May 19, 2022

Last Update Submit

September 18, 2025

Conditions

Keywords

HIV

Outcome Measures

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.

    18 months

Secondary Outcomes (2)

  • 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.

    18 months

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

    18 months

Study Arms (1)

Open Label Descovy

OTHER

Descovy for PrEP

Drug: Descovy

Interventions

HIV infection pre-exposure prophylaxis

Open Label Descovy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vivent Health

Denver, Colorado, 80245, United States

Location

Vivent Health

St Louis, Missouri, 63103, United States

Location

Viventh Health

Milwaukee, Wisconsin, 53203, United States

Location

MeSH Terms

Interventions

emtricitabine tenofovir alafenamide

Study Officials

  • Cindy Firnhaber, MD

    Vivent Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2022

First Posted

September 6, 2022

Study Start

July 19, 2022

Primary Completion

July 31, 2024

Study Completion

March 21, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations