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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)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington
Madison Clinic
RECRUITING
Seattle
Contact Information
Primary
Lisa Niemann
niemal@uw.edu
206 744-8887
Backup
Lauren Violette
lvio@uw.edu
206 616-5234
Time Frame
Start Date: 2022-01-03
Estimated Completion Date: 2024-08-31
Participants
Target number of participants: 932
Treatments
Experimental: POC NAT & Adherence 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.
No_intervention: Standard of Care
These participants will receive the clinical standard of care during their visit.
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention
Leads: University of Washington

This content was sourced from clinicaltrials.gov