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

Study Overview

• Status: Recruiting
• Conditions: HIV Prevention
• Intervention / Treatment: Drug: Descovy

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Billie Thomas; Phone Number: 720-782-5003; Email: billie.thomas@viventhealth.org
• Study Contact Backup: Name: Alexis Moore, MPH; Phone Number: 303-393-8050; Email: alexis.moore@viventhealth.org

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80245
      • Active, not recruiting
      • Vivent Health
  • Missouri
    • Saint Louis, Missouri, United States, 63103
      • Recruiting
      • Vivent Health
      • Contact: Leslie Cockerham, MD; Email: leslie.cockerham@viventhealth.org
      • Contact: Sarah Chandler; Email: sarah.chandler@Viventhealth.org
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53203
      • Active, not recruiting
      • Viventh Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open Label Descovy; Descovy for PrEP	Drug: Descovy; HIV infection pre-exposure prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months
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.	18 months

Collaborators and Investigators

• Sponsor: Vivent Health
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Cindy Firnhaber, MD, Vivent Health

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine tenofovir alafenamide
• Other Study ID Numbers: IN-US-412-6419

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes