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OpenTrials
Completed

NCT Number: NCT04880200

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Madison Clinic

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Achievement of Viral Suppression

    Time frame: 1 year

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

Other outcomes

  1. Number of Participants With Discordant SAMBA Semi-Q Results

    Time frame: 1 day

    Cases where the SAMBA Semi-Q result was discordant with laboratory plasma HIV RNA.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study 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)

Acronym: GAIN

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 10, 2021
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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