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)
University of Washington
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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
Interventions
- Diagnostic TestPOC NAT & Adherence Intervention
The POC NAT test will be the SAMBA Semi-Q HIV test. The adherence intervention will be developed by study staff and tailored for delivery along with the POC NAT results.
Location
- Madison ClinicSeattle, Washington