Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04880200

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

Led by University of Washington · Updated on 2023-04-28

932

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

C

Centers for Disease Control and Prevention

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients of unknown HIV status
  • Patients who have participated in the study before

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Madison Clinic

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

L

Lisa Niemann

CONTACT

L

Lauren Violette

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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