Clinical trial NCT05528653: Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"
Official title: Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HIV Prevention
Keywords: HIV
Lead sponsor: Vivent Health
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2022-09-06
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: : 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.
timeFrame: 18 months
Secondary outcomes:
measure: 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.
timeFrame: 18 months
measure: To assess the acceptability and implementation of the intervention by both patients and clinic staff.
timeFrame: 18 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Vivent Health
state: Colorado
city: Saint Louis
country: United States
facility: Vivent Health
state: Missouri
city: Milwaukee
country: United States
facility: Viventh Health
state: Wisconsin
Study officials:
affiliation: Vivent Health
name: Cindy Firnhaber, MD
role: PRINCIPAL_INVESTIGATOR
References: