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Recruiting

NCT Number: NCT04880200

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

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.

Recruiting

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Key information

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

Location status: Recruiting

Location contact

Joanne Stekler

CONTACT

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. Time to viral suppression

    Time frame: Participants will be enrolled for up to 6 months

    We will compare time to virologic suppression among participants randomized to the two arms.

Secondary outcomes

  1. Participation

    Time frame: Participants will be enrolled for up to 6 months

    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.

Other outcomes

  1. POC NAT limit of detection

    Time frame: Participants will be enrolled for up to 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Violette

CONTACT

[email protected]

206 616-5234

Lisa Niemann

CONTACT

[email protected]

206 744-8887

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
2024
Study completion
2024
First posted
May 10, 2021
Registry last updated
Apr 28, 2023

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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