NCT03755986

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

February 22, 2017

Last Update Submit

November 25, 2018

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

  • Questionnaire scoring each step of performing the self-test

    To assess the ability of typical self-test users to follow the test instructions and perform the test accurately and to identify any issues or difficulty they may experience whilst performing the test.

    Assessed at one time point per patient (visit 1) approximately 1 hour

  • Questionnaire scoring each step of performing the self-test

    To assess the ability of typical self-test users to perform the test accurately

    Assessed at one time point per patient (visit 1) approximately 1 hour

  • Questionnaire scoring each step of performing the self-test

    To identify any issues or difficulty the self-test users may experience whilst performing the test.

    Assessed at one time point per patient (visit 1) approximately 1 hour

Secondary Outcomes (3)

  • Questionnaire scoring each step of performing the self-test

    Assessed at one time point only per patient (visit 1)approximately 1 hour

  • Comparison of self-test user result against the standard of care laboratory test for HIV

    Assessed at one time point only per patient (visit 1)approximately 1 hour

  • Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV

    Assessed at one time point only per patient (visit 1)approximately 1 hour

Study Arms (1)

ATOMO Diagnostic Test

OTHER

All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.

Device: ATOMO Diagnostic Test

Interventions

ATOMO Diagnostic TestDEVICE

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

ATOMO Diagnostic Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recruitment will be restricted to people who satisfy the following criteria:
  • Attending health clinic or community-based testing study sites
  • Aged 18 years or more
  • Requesting HIV testing and/or in whom HIV testing is indicated
  • Willing and able to give their own informed consent
  • Willing to participate in and comply with the study procedures

You may not qualify if:

  • The following people will be excluded from the study:
  • People in whom HIV testing is not indicated or not appropriate
  • People not fluent in English in whom provision of informed consent or compliance with the study procedures may be problematic
  • People who have participated in the study previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Terrance J Thiel

    Atomo Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof

Study Record Dates

First Submitted

February 22, 2017

First Posted

November 28, 2018

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

November 28, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)