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Antiretroviral
Telehealth-Delivered PrEP for HIV Prevention (e-PrEP Trial)
Phase 4
Recruiting
Led By Cindy Firnhaber, MD
Research Sponsored by Vivent Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
e-PrEP Trial Summary
This trial will test if using Telehealth to provide access to HIV PrEP will help engage more Black and Latino Men who have sex with Men in care.
Who is the study for?
This trial is for Black and Latino men who have sex with men (MSM), are HIV negative, over 18 years old, can consent in English or with an interpreter, and live within the state of the healthcare provider. They should not have used PrEP extensively in the past year or have health issues that would interfere with study participation.Check my eligibility
What is being tested?
The 'e-PrEP' trial is testing whether using Telehealth to provide access to HIV prevention medication (PrEP) increases its use among Black and Latino MSM compared to traditional methods.See study design
What are the potential side effects?
Descovy for PrEP may cause side effects like nausea, diarrhea, headache, fatigue, stomach pain. Rarely it might affect kidney function, bone density or cause liver problems.
e-PrEP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
: 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.
Secondary outcome measures
To assess the acceptability and implementation of the intervention by both patients and clinic staff.
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.
Side effects data
From 2020 Phase 3 trial • 15 Patients • NCT040794527%
Diarrhea
7%
Thoracic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Doravirine+TAF/FTC Arm (Single Arm)
e-PrEP Trial Design
1Treatment groups
Experimental Treatment
Group I: Open Label DescovyExperimental Treatment1 Intervention
Descovy for PrEP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Descovy
2020
Completed Phase 3
~320
Find a Location
Who is running the clinical trial?
Vivent HealthLead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,329 Total Patients Enrolled
Cindy Firnhaber, MDPrincipal InvestigatorVivent Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I haven't used PrEP for more than 30 days in the past year.I can understand and sign the consent form, with an interpreter if needed.I am a cisgender woman.I am 50 or older with a low kidney function.I am over 18 and tested HIV negative recently.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label Descovy
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the present enrollment capacity of this experiment?
"Affirmative. Information available on clinicaltrials.gov attests to this medical experiment's ongoing recruitment process, which began in July 19th 2022 and was most recently updated at the end of August 2022. The prospective patient pool is estimated to be 150 individuals divided among 3 trial sites."
Answered by AI
Can individuals still join the experiment at this point in time?
"Affirmative. Evidenced on clinicaltrials.gov, recruitment for this study began on July 19th 2022 and was most recently revised August 31st 2022. 150 individuals are sought from 3 separate trial sites to participate in the research."
Answered by AI
Has this therapeutic intervention been validated by the Food and Drug Administration?
"This treatment has been approved, and therefore its safety is rated 3 out of 3."
Answered by AI
Who else is applying?
What site did they apply to?
Vivent Health
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve been wanting to try PReP again, I tried it years ago.
PatientReceived 2+ prior treatments
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