RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2022-01-03
Study Completion:2024-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04880200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Persons who are HIV-positive and seeking care at Madison Clinic.
  2. * 18 years of age or older
  3. * Patient's provider is willing to deliver adherence intervention
  4. * Patient is getting a laboratory RNA viral load test that day.
  5. * Able to read and speak English
  1. * Patients of unknown HIV status
  2. * Patients who have participated in the study before

Contacts and Locations

Study Contact

Lisa Niemann
CONTACT
206 744-8887
niemal@uw.edu
Lauren Violette
CONTACT
206 616-5234
lvio@uw.edu

Principal Investigator

Joanne D Stekler, MD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

Madison Clinic
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Joanne D Stekler, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-03
Study Completion Date2024-08-31

Study Record Updates

Study Start Date2022-01-03
Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • point of care testing
  • nucleic acid testing

Additional Relevant MeSH Terms

  • HIV Infections