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)
3 other identifiers
interventional
932
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Jan 2022
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedStudy Start
First participant enrolled
January 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedApril 28, 2023
April 1, 2023
2.7 years
April 27, 2021
April 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Participation
Participants will be enrolled for up to 6 months
Other Outcomes (1)
POC NAT limit of detection
Participants will be enrolled for up to 6 months
Study Arms (2)
POC NAT & Adherence Intervention
EXPERIMENTALThese 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.
Standard of Care
NO INTERVENTIONThese participants will receive the clinical standard of care during their visit.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients of unknown HIV status
- Patients who have participated in the study before
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Madison Clinic
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne D Stekler, MD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, School of Medicine
Study Record Dates
First Submitted
April 27, 2021
First Posted
May 10, 2021
Study Start
January 3, 2022
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
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.