Clinical trial NCT04880200: Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: HIV
point of care testing
nucleic acid testing
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-05-10
Enrollment: 932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to viral suppression
timeFrame: Participants will be enrolled for up to 6 months
Secondary outcomes:
measure: Participation
timeFrame: Participants will be enrolled for up to 6 months
Other outcomes:
measure: POC NAT limit of detection
timeFrame: Participants will be enrolled for up to 6 months
Locations:
city: Seattle
country: United States
facility: Madison Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Joanne D Stekler, MD
role: PRINCIPAL_INVESTIGATOR
References: