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

HIV Prevention Clinical Trial

— e-PrEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528653
• Other study ID #: IN-US-412-6419
• Status: Recruiting
• Phase: Phase 4
• Start date: July 19, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Vivent Health
• Contact: Billie Thomas
• Phone: 720-782-5003
• Email: billie.thomas[@]viventhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Drug:
• Descovy
HIV infection pre-exposure prophylaxis

Locations

Country	Name	City	State
United States	Vivent Health	Denver	Colorado
United States	Viventh Health	Milwaukee	Wisconsin
United States	Vivent Health	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Vivent Health	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	: 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	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
Secondary	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