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

Study acronym: GAIN
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Primary completion date changed from estimate of Aug 31, 2024 to Dec 23, 2025 · Results posted: Sep 17, 2026 · Trial completed · 3 more Show 6 more changesShow less
    • Primary completion date changed from estimate of Aug 31, 2024 to Dec 23, 2025
    • Results posted: Sep 17, 2026
    • Trial completed
    • Final enrollment: 194 participants (planned 932)
    • Interventions: POC NAT & Adherence Intervention (Diagnostic Test) to POC NAT & Adherence Intervention (Diagnostic Test)
    • Eligibility criteria expanded, about 7 words
  2. Re-verified, no change to tracked fieldsv4
  3. Primary completion date changed from estimate of Aug 31, 2024 to Dec 23, 2025 Start date: Jan 3, 2022 to Mar 1, 2022 · Primary endpoint revised · Trial status: Recruiting to Active, Not Recruiting · 4 morev3 Show 7 more changesShow less
    • Start date: Jan 3, 2022 to Mar 1, 2022
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 932 to confirmed 194
    • Completion date: Aug 31, 2024 to May 31, 2026
    • Site details revised
    • Secondary endpoints shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 1, 2021 to Jan 3, 2022 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 1, 2021 to Jan 3, 2022
    • Study sites: 0 to 1
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04880200
Lead Sponsor University of Washington
Collaborators: Centers for Disease Control and Prevention
Conditions HIV Infections
Enrollment 194 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov