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NCT04880200 · ClinicalTrials.gov registry record · NA
Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests
A NA study, sponsored by University of Washington.
- Recruiting
- Registry status
- NA
- Development phase
- 932
- Enrollment target
NCT04880200: Recruiting NA study, sponsored by University of Washington.
NCT04880200 is a NA study that is actively recruiting participants, run by University of Washington. The registered enrollment target is 932 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04880200, a NA study, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- NA
- Development phase
- 932 participants
- Enrollment target
Study Summary
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.
Primary Outcome
We will compare time to virologic suppression among participants randomized to the two arms.
Interventions
- DIAGNOSTIC_TEST POC NAT & Adherence Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 932 participants |
| Start Date | 2022-01-03 |
| Est. Completion | 2024-08-31 |
| Phase | NA |
What NCT04880200 shows while recruiting
NCT04880200 is an interventional study that assigns participants to a tested intervention. The registered 932 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 1 intervention - of which POC NAT & Adherence Intervention is the first listed.
NCT04880200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04880200 about?
NCT04880200 is a clinical study titled "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 specific...
What is the current status of trial NCT04880200?
This trial is currently recruiting. It is a NA study. The enrollment target is 932 participants. The study started on 2022-01-03. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT04880200?
The interventions under investigation include: POC NAT & Adherence Intervention (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04880200?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04880200's enrollment target sits among peer trials
932 123rd of 2000 higher than 1,878 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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