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Nucleic Acid Test

POC NAT for HIV Detection and Care Management (GAIN Trial)

N/A

Recruiting

Led By Joanne D Stekler, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be enrolled for up to 6 months

Awards & highlights

GAIN Trial Summary

This trial will test a new method of HIV testing, PrEP and PEP uptake, and time to HIV treatment outcomes in community and clinical settings. It will also assess the cost-effectiveness of the method.

Who is the study for?

This trial is for adults over 18 who are HIV-positive and seeking care at Madison Clinic. They must be able to read and speak English, have their provider's approval to receive an adherence intervention, and be getting a lab RNA viral load test the same day.Check my eligibility

What is being tested?

The study tests point-of-care nucleic acid testing (POC NAT) in community and clinical settings for its accuracy in detecting HIV, impact on PrEP use among HIV-negative individuals, care outcomes for those positive, and time to virus suppression with tailored behavioral interventions.See study design

What are the potential side effects?

Since this trial focuses on diagnostic testing methods rather than medications or treatments, direct side effects from the interventions are not applicable. However, there may be indirect impacts related to receiving test results.

GAIN 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.

GAIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be enrolled for up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be enrolled for up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be enrolled for up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to viral suppression

Secondary outcome measures

Participation

Other outcome measures

POC NAT limit of detection

GAIN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: POC NAT & Adherence InterventionExperimental Treatment1 Intervention

These participants will receive the POC NAT test during their study visit. The result will be conveyed to their provider, who will deliver the result and an adherence intervention.

Group II: Standard of CareActive Control1 Intervention

These participants will receive the clinical standard of care during their visit.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,846,834 Total Patients Enrolled

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,476,470 Total Patients Enrolled

Joanne D Stekler, MDPrincipal InvestigatorUniversity of Washington

Media Library

POC NAT (Nucleic Acid Test) Clinical Trial Eligibility Overview. Trial Name: NCT04880200 — N/A

Human Immunodeficiency Virus Infection Research Study Groups: Standard of Care, POC NAT & Adherence Intervention

Human Immunodeficiency Virus Infection Clinical Trial 2023: POC NAT Highlights & Side Effects. Trial Name: NCT04880200 — N/A

POC NAT (Nucleic Acid Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04880200 — N/A

Frequently Asked Questions

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

Are new participants being accepted for this experiment?

"Currently, the information hosted on clinicaltrials.gov indicates that this medical trial is open to participants. The trial began recruiting individuals as of March 1st 2022 and was last updated April 26th 2023."

Answered by AI

What is the enrollment capacity of this research project?

"Correct. The information found on clinicaltrials.gov provides evidence that this medical research, which had its inception on the 3rd of January 2022, is presently searching for participants. Approximately 932 volunteers must be recruited from a single center."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests

Joanne Stekler, MD MPH 2022. "Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04880200.

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