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

Sponsor

University of Washington (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04880200

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

932

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Diagnostic Test: POC NAT & Adherence Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

932 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

For the aim #3 RCT, we will randomize participants 1:1 to the POC NAT intervention arm and to standard of care. The intervention will include a SAMBA test and adherence counseling intervention developed by the study team to accompany delivery of test results. The study team will train participating primary care providers (PCPs) in delivery of the adherence counseling intervention. Study staff will discuss the study, obtain informed consent, and, for participants randomized to POC NAT, perform SAMBA and provide results to the PCP. Study staff will perform venipuncture, ensure that individual laboratory NAT is performed, and administer a brief CASI. PCPs will deliver the POC NAT result and adherence counseling intervention to patients during their visit. Participants will be asked to sign an ROI that allows the study to share POC NAT results with the PCP and allows the study staff to obtain outcomes measures from clinical patient data for longitudinal follow up.For the aim #3 RCT, we will randomize participants 1:1 to the POC NAT intervention arm and to standard of care. The intervention will include a SAMBA test and adherence counseling intervention developed by the study team to accompany delivery of test results. The study team will train participating primary care providers (PCPs) in delivery of the adherence counseling intervention. Study staff will discuss the study, obtain informed consent, and, for participants randomized to POC NAT, perform SAMBA and provide results to the PCP. Study staff will perform venipuncture, ensure that individual laboratory NAT is performed, and administer a brief CASI. PCPs will deliver the POC NAT result and adherence counseling intervention to patients during their visit. Participants will be asked to sign an ROI that allows the study to share POC NAT results with the PCP and allows the study staff to obtain outcomes measures from clinical patient data for longitudinal follow up.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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)

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Time to viral suppression [Participants will be enrolled for up to 6 months]
We will compare time to virologic suppression among participants randomized to the two arms.

Secondary Outcome Measures

Participation [Participants will be enrolled for up to 6 months]
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.

Other Outcome Measures

POC NAT limit of detection [Participants will be enrolled for up to 6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Washington
Centers for Disease Control and Prevention

Investigators

Principal Investigator: Joanne D Stekler, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joanne Stekler, MD MPH, Professor, School of Medicine, University of Washington

ClinicalTrials.gov Identifier:

NCT04880200

Other Study ID Numbers:

STUDY00010387
6 U01 PS 005196-01-01

First Posted:

May 10, 2021

Last Update Posted:

May 10, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Joanne Stekler, MD MPH, Professor, School of Medicine, University of Washington

HIV

point of care testing

nucleic acid testing

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of May 10, 2021