Point-of-care HIV nucleic acid testing to improve diagnosis, linkage, and prevention
The GAIN (Greater Access and Impact With NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests (NATs)
This project will test whether rapid point-of-care nucleic acid tests plus an adherence intervention help find early HIV infections, speed linkage to care for people with HIV, and increase uptake and persistence of PEP/PrEP for people testing negative.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 932 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04880200 on ClinicalTrials.gov |
What this trial studies
The project will develop, implement, and test models for using point-of-care nucleic acid testing (POC NAT) in community and clinical settings for people seeking HIV testing, PEP/PrEP, and for people living with HIV. It will measure the sensitivity and specificity of a qualitative POC NAT compared with laboratory RNA testing and examine impacts on PrEP uptake and persistence and on time to HIV care milestones for those testing positive. A POC NAT–tailored behavioral adherence intervention will be tested for effects on time to virologic suppression among people on ART. The study will also collect data on acceptability, feasibility, and costs to inform cost-effectiveness and potential implementation.
Who should consider this trial
Good fit: Adults (age 18+) who are seeking HIV testing or PEP/PrEP services or who are HIV-positive and receiving care at the Madison Clinic, able to read and speak English, with a provider willing to deliver the adherence intervention, are ideal candidates.
Not a fit: Minors, non-English speakers, people not seen at the Madison Clinic, those with unknown HIV status, or individuals who have already participated in the study are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could detect acute HIV infections earlier, shorten time to linkage and treatment, and increase uptake and persistence of prevention services like PrEP.
How similar studies have performed: Previous pilot studies have shown POC nucleic acid tests can detect acute HIV earlier than antibody tests and have promising accuracy, but large-scale implementation evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persons who are HIV-positive and seeking care at Madison Clinic. * 18 years of age or older * Patient's provider is willing to deliver adherence intervention * Patient is getting a laboratory RNA viral load test that day. * Able to read and speak English Exclusion Criteria: * Patients of unknown HIV status * Patients who have participated in the study before
Where this trial is running
Seattle, Washington
- Madison Clinic — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Joanne D Stekler, MD — University of Washington
- Study coordinator: Lisa Niemann
- Email: niemal@uw.edu
- Phone: 206 744-8887
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.