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Viral Load Test

Point-of-Care Tests for HIV Diagnosis (EHPOC Trial)

N/A
Recruiting
Led By Matthew Hamill, MBChB, Ph.D
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

EHPOC Trial Summary

This trial will compare the accuracy of four different kinds of point-of-care tests for HIV diagnosis, to see which is best.

Who is the study for?
This trial is for adults over 18 who are living with or at high risk for HIV, including MSM/transgender individuals, those using injection drugs, have known STIs or are being screened for them. Participants must be willing to share lab results, undergo blood and oral fluid tests, complete a questionnaire, attend follow-up visits, and allow their samples to be sent to the CDC.Check my eligibility
What is being tested?
The study is testing rapid point-of-care (POC) technologies like Cepheid GeneXpert HIV-1 Qual POC HIV VL test and others against standard lab procedures. It aims to see if these can speed up diagnosis of HIV/Syphilis and improve linking patients quickly to treatments or prevention services during one clinic visit.See study design
What are the potential side effects?
Since this trial focuses on diagnostic tests rather than medications or therapies, side effects may include discomfort from blood draws or oral fluid collection. There might also be emotional impacts due to immediate knowledge of an HIV/Syphilis diagnosis.

EHPOC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

EHPOC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants linked either to PrEP or ART
Secondary outcome measures
Change in proportion of participants reporting condom-less sex
HIV: time to linkage to either PrEP or ART
Syphilis: time to linkage to syphilis treatment

EHPOC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: POC HIV VL TestingExperimental Treatment3 Interventions
Participants will receive the standard of care tests (DPP HIV-Syphilis Test System, OraQuick) plus the HIV POC VL test.
Group II: SOC HIV TestingActive Control2 Interventions
Participants will receive routine standard of care HIV testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OraQuick
2018
N/A
~10000

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,822,757 Total Patients Enrolled
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,476,994 Total Patients Enrolled
Matthew Hamill, MBChB, Ph.DPrincipal InvestigatorJohns Hopkins University

Media Library

Cepheid GeneXpert HIV-1 Qual POC HIV VL test (Viral Load Test) Clinical Trial Eligibility Overview. Trial Name: NCT04793750 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: POC HIV VL Testing, SOC HIV Testing
Human Immunodeficiency Virus Infection Clinical Trial 2023: Cepheid GeneXpert HIV-1 Qual POC HIV VL test Highlights & Side Effects. Trial Name: NCT04793750 — N/A
Cepheid GeneXpert HIV-1 Qual POC HIV VL test (Viral Load Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04793750 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment ongoing for this experiment?

"This medical trial is open to candidates; its listing on clinicaltrials.gov was first published in August of 2021, with the most recent update occurring a year later in 2022."

Answered by AI

How many individuals are currently involved in the experiment?

"Affirmative. According to data posted on clinicaltrials.gov, this medical trial has commenced recruitment efforts; the study was originally advertised on August 18th 2021 and its details were recently updated on August 9th 2022. The experiment requires 408 participants from 3 different healthcare facilities."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health Clinics
Johns Hopkins Hospital Emergency Department (JHHED)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have been positive for almost 38 years and if I can help someone else who the trial I would do so.
PatientReceived 2+ prior treatments
Recent research and studies
~0 spots leftby May 2024