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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Washington
- Enrollment
- 932
- Locations
- 2
- Primary Endpoint
- Time to viral suppression
Study Overview
Brief Summary
This project will develop, implement, and evaluate models for use of point-of-care nucleic acid testing (POC NAT) among HIV-negative persons seeking HIV testing, PEP, and PrEP and HIV-positive persons in community and clinical settings. Study aims #1 and #2 will evaluate the sensitivity and specificity of a qualitative POC NAT in persons not known to be HIV-positive and will determine the impact of its use on PrEP uptake and persistence among persons testing HIV-negative and on time to HIV continuum of care outcomes among persons testing HIV-positive. Aim #3 will implement a POC NAT-tailored behavioral intervention to evaluate impact on time to virologic suppression among PLWH receiving ART. Aim #4 will quantify the acceptability and feasibility of implementation of POC NAT in community and clinical settings and collect cost and related data for cost-effectiveness analyses. Finally, in Aim #5, a distinct but related study will compare the sensitivity, specificity, and agreement of multiple POC NATs over a range of HIV RNA levels.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to viral suppression
Time Frame: Participants will be enrolled for up to 6 months
We will compare time to virologic suppression among participants randomized to the two arms.
Secondary Outcomes
- Participation(Participants will be enrolled for up to 6 months)
Investigators
Joanne Stekler, MD MPH
Professor, School of Medicine
University of Washington