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NCT04880200Completed

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

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)

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
194 (actual)
First submitted
27 Apr 2021
Start date
1 Mar 2022
Primary completion date
23 Dec 2025
Lead sponsor
University of Washington
Diseases
HIV
NCT number
NCT04880200

What you commit to

  • Study type: Interventional
  • Participants enrolled: 194
  • From 1 Mar 2022 to the primary completion date, 23 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients of unknown HIV status

Other

  • Patients who have participated in the study before

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Madison Clinic
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.