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Performance and Usability Evaluation of the Atomo HIV Self-Test

NCT03755986 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2018-11-28

No results posted yet for this study

Summary

The study seeks to enroll 501+ patients to use a HIV self testing device to test for HIV in a blood sample drawn by finger prick. The purpose of the trial is to assess the usability of the device by providing participants with video and written instructions on how to correctly obtain a result from the device.

Conditions

  • HIV Infections

Interventions

DEVICE

ATOMO Diagnostic Test

The ATOMO diagnostic test device is the only intervention used in this study.

Sponsors & Collaborators

  • Atomo Diagnostics

    collaborator UNKNOWN

  • Holdsworth House Medical Practice

    lead OTHER

Principal Investigators

  • Terrance J Thiel · Atomo Diagnostics

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-05-31
Completion
2017-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03755986 on ClinicalTrials.gov