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

Vivent Health

Status and phase: Enrolling; Phase 4

Conditions: HIV Prevention

Treatments: Drug: Descovy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05528653

IN-US-412-6419

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Open Label Descovy

Other group

Description:

Descovy for PrEP

Treatment:

Drug: Descovy