Using telehealth to improve access to HIV prevention services for Black and Latino communities
Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"
This study tests if using telehealth can help more Black and Latino men who have sex with men and transgender individuals start and stay on HIV prevention medication by making it easier to access services.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Vivent Health Academic / other |
| Locations | 3 sites (Denver, Colorado and 2 other locations) |
| Trial ID | NCT05528653 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a telehealth model designed to increase the uptake of HIV pre-exposure prophylaxis (PrEP) among Black and Latino men who have sex with men (MSM) and transgender individuals. By offering same-day appointments and navigation support, the study aims to address barriers such as transportation, childcare, and stigma that have historically hindered access to PrEP. The research employs an effectiveness-hybrid design to assess both clinical outcomes and the implementation strategy's success. The hypothesis is that reducing barriers will lead to higher rates of PrEP initiation and persistence in underserved communities.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-negative Black and Latino MSM and transgender individuals aged 18 and older who have not used PrEP in the past year.
Not a fit: Patients who are HIV positive, under 18 years of age, or lack access to the internet or telehealth devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase access to HIV prevention services for marginalized populations, ultimately reducing HIV transmission rates.
How similar studies have performed: Other studies have shown promise in using telehealth to improve access to healthcare services, suggesting that this approach may be effective in increasing PrEP uptake.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado and 2 other locations
- Vivent Health — Denver, Colorado, United States (Active_not_recruiting)
- Vivent Health — Saint Louis, Missouri, United States (Recruiting)
- Viventh Health — Milwaukee, Wisconsin, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Cindy Firnhaber, MD — Vivent Health
- Study coordinator: Billie Thomas
- Email: billie.thomas@viventhealth.org
- Phone: 720-782-5003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.