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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
Must not have
Aged <18 years
Unwilling to undergo study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am not willing to follow the study's required procedures.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants linked either to PrEP or ART
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,339 Previous Clinical Trials
14,881,363 Total Patients Enrolled
Centers for Disease Control and PreventionFED
892 Previous Clinical Trials
22,000,354 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
~37 spots leftby May 2025
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