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

University of Washington

Status: Enrolling

Conditions: HIV Infections

Treatments: Diagnostic Test: POC NAT & Adherence Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04880200

STUDY00010387

6 U01 PS 005196-01-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 932 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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932 participants in 2 patient groups

POC NAT & Adherence Intervention

Experimental group

Description:

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.

Treatment:

Diagnostic Test: POC NAT & Adherence Intervention

Standard of Care

No Intervention group

Description:

These participants will receive the clinical standard of care during their visit.