Clinical trial

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

Name
IN-US-412-6419
Description
To evaluate if utilizing Telehealth medicine for access to HIV PrEP will engage more Black and Latino Men who have sex with Men (MSM)
Trial arms
Trial start
2022-07-19
Estimated PCD
2024-07-31
Trial end
2024-07-31
Status
Recruiting
Phase
Early phase I
Treatment
Descovy
HIV infection pre-exposure prophylaxis
Arms:
Open Label Descovy
Size
150
Primary endpoint
: 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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-01-05

1 organization

1 product

1 indication

Organization
Vivent Health
Product
Descovy
Indication
HIV