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

HIV Infections Clinical Trial

— GAIN  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880200
• Other study ID #: STUDY00010387
• Secondary ID: 6 U01 PS 005196-
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2023
• Source: University of Washington
• Contact: Lisa Niemann
• Phone: 206 744-8887
• Email: niemal[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 932
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

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.

Locations

Country	Name	City	State
United States	Madison Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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