Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test

April 23, 2025 updated by: Tasha Ramsey, Nova Scotia Health Authority
This study aims to validate the percent agreement of the INSTI Multiplex Human Immunodeficiency (HIV) 1/2 syphilis antibody (Ab) test (INSTI POCT) when used as a self-test by patients compared to conventional serologic testing.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Branch #1: Participants known to have an HIV infection - Inclusion criteria:

• Previously documented positive HIV serology

Branch #2: Participants known to have a history of syphilis infection - Inclusion criteria:

• Documented positive syphilis serology

Branch #3: Participants with no known HIV or syphilis infections - Inclusion criteria:

• No documented positive HIV or syphilis serology

Exclusion criteria:

Unable to speak and understand English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: INSTI HIV/syphilis Point of Care Self-Test
Diagnostic test: INSTI HIV/syphilis Point of Care Self-Test Administration
The INSTI Human Immunodeficiency Virus (HIV)/syphilis POCT is a rapid, single-use, flow-through immunoassay that is Health Canada-approved as a screening test for detecting antibodies to HIV1/2 and syphilis using a fingerstick blood sample.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent agreement of the INSTI HIV/syphilis POCT when used to self-test for antibodies to HIV 1/2 and syphilis when compared to conventional serologic results.
Time Frame: Determined at the end of the implementation period (approximately 6 months).
Determined at the end of the implementation period (approximately 6 months).
Participant-rated clarity of instructional materials and satisfaction with INSTI HIV/syphilis self-testing
Time Frame: Immediately after self-testing (Day 0)

This measure includes two domains assessed immediately following completion of the self-test:

  1. Instructional Clarity: Proportion of participants who agree, are neutral, or disagree with statements related to the clarity and usefulness of the video and infographic
  2. Self-Test Satisfaction: Proportion of participants who agree, are neutral, or disagree with statements related to their satisfaction with the self-testing experience.

Responses to Likert-style questions will be reported as percentages of participants selecting each category (agree, neutral, disagree) per question.
Immediately after self-testing (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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