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

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)

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 Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Diagnostic test: POC NAT & Adherence Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 932
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Niemann; Phone Number: 206 744-8887; Email: niemal@uw.edu
• Study Contact Backup: Name: Lauren Violette; Phone Number: 206 616-5234; Email: lvio@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Madison Clinic
      • Contact: Joanne Stekler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: POC 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.
No Intervention: Standard of Care; These participants will receive the clinical standard of care during their visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to viral suppression	We will compare time to virologic suppression among participants randomized to the two arms.	Participants will be enrolled for up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation	We will use descriptive statistics to report on the proportion of Madison primary care providers (PCP)s willing to participate in the RCT and the proportion of patients who agree to study enrollment.	Participants will be enrolled for up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
POC NAT limit of detection	We will report on the limit of detection of the SAMBA test, using the plasma HIV RNA level as gold standard, and the agreement (kappa) of SAMBA and plasma HIV RNA level, dichotomized at 1000 copies/mL	Participants will be enrolled for up to 6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: HIV; point of care testing; nucleic acid testing
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: STUDY00010387; 6 U01 PS 005196-01-01 (Other Grant/Funding Number: CDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Intellectual property and data generated will be administered in accordance with UW and CDC policies. Final determinations for data sharing will be based on guidelines for use determined by the Publication Committee. Data obtained during this project will be available at the end of the funding cycle or within a year of publication of major findings, whichever is later. Requests for data or specimens must be made in writing, and human subjects approval must be obtained prior to data transfer. Data will be provided from the Data Center electronically, stripped of identifying information. Investigators receiving data will be asked to sign an agreement stipulating that they will (1) use data only for not-for-profit research purposes (unless negotiated otherwise with the Publication Committee); (2) not attempt to identify any individual participant; (3) secure data using appropriate technology and not share data with anyone else; and (4) destroy data after analyses are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No