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

NCT04880200 | Completed Results FDA Device

• 3 other identifiers: STUDY000103876 U01 PS 005196-01-016U01PS005196
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

This project (NCT04880200) 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.

Conditions

HIV Infections

Keywords

HIV; point of care testing; nucleic acid testing

Outcome Measures

Primary Outcomes (1)

• Achievement of Viral Suppression

  Participants achieving an undetectable viral load during 1 year of follow up

  1 year

Other Outcomes (1)

• Number of Participants With Discordant SAMBA Semi-Q Results

  1 day

Study Arms (2)

POC NAT & Adherence Intervention

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

These participants will receive the clinical standard of care during their visit.

Interventions

POC NAT & Adherence Intervention DIAGNOSTIC_TEST

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.

POC NAT & Adherence Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Madison Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Niemann LA, Violette LR, Cornelius-Hudson A, Murphy M, Capili C, Dai M, Wagner A, Frey S, Dhanireddy S, Taylor SE, Hoover KW, Stekler JD. Feasibility, Acceptability, and Test Performance of Point-of-Care Nucleic Acid Tests for HIV Testing and Viral Load Monitoring in the United States: Prospective Longitudinal Mixed-Methods Study. JMIR Res Protoc. 2026 Jul 23;15:e84625. doi: 10.2196/84625.

  PMID: 42492499 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Joanne Stekler
• Organization: University of Washington

jstekler@uw.edu

206-744-8312

Study Officials

• Joanne D Stekler, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 10, 2021
• Study Start: March 1, 2022
• Primary Completion: December 23, 2025
• Study Completion: May 31, 2026
• Last Updated: September 17, 2026
• Results First Posted: September 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)