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

Phase 4

Recruiting

• Conditions: HIV Prevention
• Interventions: Drug: Descovy

• Registration Number: NCT05528653
• Lead Sponsor: Vivent Health

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)

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 Timeline

• Study First Submitted: 2022-05-19
• Study Start: 2022-07-19
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Descovy	Descovy	Descovy for PrEP

Primary Outcome Measures

Name	Time	Method
: 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.	18 months	Offer PrEP care via tele-health to reduce obstacles that clients have in coming to clinic.

Secondary Outcome Measures

Name	Time	Method
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	Facilitate maintenance of care by offering Tele-health for initial and ongoing PrEP care to reduce social and structural barriers.
To assess the acceptability and implementation of the intervention by both patients and clinic staff.	18 months	Obtain quantitative feedback via survey about services provided via Telehealth from patients and clinic staff.

Trial Locations

Locations (2)

Vivent Health; 🇺🇸 Saint Louis, Missouri, United States

Viventh Health; 🇺🇸 Milwaukee, Wisconsin, United States