RecruitingNot ApplicableNCT04880200

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

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)


Sponsor

University of Washington

Enrollment

932 participants

Start Date

Jan 3, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • Persons who are HIV-positive and seeking care at Madison Clinic.
  • 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 Criteria2

  • Patients of unknown HIV status
  • Patients who have participated in the study before

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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.


Locations(1)

Madison Clinic

Seattle, Washington, United States

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NCT04880200


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