Trial Outcomes & Findings for OraQuick® HIV Self-Test Study in Canada (NCT NCT05020353)

NCT ID: NCT05020353

Last Updated: 2025-05-11

Results Overview

Sensitivity and specificity of study participants' self-interpreted self-test results with the OraQuick® HIV Self-Test versus the HIV status as determined by the 4th generation EIA and confirmatory testing for HIV as necessary.

Recruitment status

COMPLETED

Study phase

Target enrollment

951 participants

Primary outcome timeframe

Outcome measured following POC tests on Visit 1, Day 1 for each participant.

Results posted on

2025-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Device Observed self-test of oral fluid with the OraQuick HIV Self-Test OraQuick® HIV Self-Test: OraQuick® HIV Self-Test in oral fluid conducted by observed intended users (non-healthcare professional and inexperienced in HIV self-testing) compared to laboratory 4th generation Ag/Ab enzyme immunoassay (EIA) results performed on venous blood.
Overall Study STARTED	951
Overall Study COMPLETED	911
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Device Observed self-test of oral fluid with the OraQuick HIV Self-Test OraQuick® HIV Self-Test: OraQuick® HIV Self-Test in oral fluid conducted by observed intended users (non-healthcare professional and inexperienced in HIV self-testing) compared to laboratory 4th generation Ag/Ab enzyme immunoassay (EIA) results performed on venous blood.
Overall Study Protocol Violation	7
Overall Study Withdrawal by Subject	33

Baseline Characteristics

Totals for each category varied based on participant responses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Device n=911 Participants Observed self-test of oral fluid with the OraQuick HIV Self-Test OraQuick® HIV Self-Test: OraQuick® HIV Self-Test in oral fluid conducted by observed intended users (non-healthcare professional and inexperienced in HIV self-testing) compared to laboratory 4th generation Ag/Ab enzyme immunoassay (EIA) results performed on venous blood.
Age, Customized 18-25 years	307 Participants n=99 Participants • Totals for each category varied based on participant responses
Age, Customized 26-35 years	302 Participants n=99 Participants • Totals for each category varied based on participant responses
Age, Customized 36-45 years	158 Participants n=99 Participants • Totals for each category varied based on participant responses
Age, Customized 46-55 years	73 Participants n=99 Participants • Totals for each category varied based on participant responses
Age, Customized >55 years	70 Participants n=99 Participants • Totals for each category varied based on participant responses
Age, Customized Prefer not to answer	1 Participants n=99 Participants • Totals for each category varied based on participant responses
Sex/Gender, Customized Cis-male	434 Participants n=99 Participants • Totals for each category varied based on participant responses
Sex/Gender, Customized Cis-female	450 Participants n=99 Participants • Totals for each category varied based on participant responses
Sex/Gender, Customized Other	26 Participants n=99 Participants • Totals for each category varied based on participant responses
Sex/Gender, Customized Prefer not to anwer	1 Participants n=99 Participants • Totals for each category varied based on participant responses
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	911 Participants n=99 Participants
Race/Ethnicity, Customized White	235 Participants n=99 Participants
Race/Ethnicity, Customized African/Caribbean/Black	211 Participants n=99 Participants
Race/Ethnicity, Customized Indigenous	46 Participants n=99 Participants
Race/Ethnicity, Customized Middle Eastern/North African	25 Participants n=99 Participants
Race/Ethnicity, Customized East Asian	85 Participants n=99 Participants
Race/Ethnicity, Customized South Asian	222 Participants n=99 Participants
Race/Ethnicity, Customized LatinX	54 Participants n=99 Participants
Race/Ethnicity, Customized Other	33 Participants n=99 Participants
Region of Enrollment Canada · British Columbia	102 Participants n=99 Participants
Region of Enrollment Canada · Manitoba	56 Participants n=99 Participants
Region of Enrollment Canada · Ontario	662 Participants n=99 Participants
Region of Enrollment Canada · Quebec	91 Participants n=99 Participants
Education No formal education	0 Participants n=99 Participants • Totals for each category varied based on participant responses
Education Primary school	20 Participants n=99 Participants • Totals for each category varied based on participant responses
Education Secondary school	226 Participants n=99 Participants • Totals for each category varied based on participant responses
Education College	242 Participants n=99 Participants • Totals for each category varied based on participant responses
Education University or higher	420 Participants n=99 Participants • Totals for each category varied based on participant responses
Education Prefer not to answer	3 Participants n=99 Participants • Totals for each category varied based on participant responses
Employment Employed	405 Participants n=99 Participants • Totals for each category varied based on participant responses
Employment Student	261 Participants n=99 Participants • Totals for each category varied based on participant responses
Employment Retired	23 Participants n=99 Participants • Totals for each category varied based on participant responses
Employment Unemployed	215 Participants n=99 Participants • Totals for each category varied based on participant responses
Employment Prefer not to answer	7 Participants n=99 Participants • Totals for each category varied based on participant responses
HIV Status Negative status	485 Participants n=99 Participants
HIV Status Unknown status/never tested	426 Participants n=99 Participants
Medical Condition Diabetes	21 Participants n=99 Participants • Totals for each category varied based on participant responses
Medical Condition Hypertension	23 Participants n=99 Participants • Totals for each category varied based on participant responses
Medical Condition Sexually transmitted infection	13 Participants n=99 Participants • Totals for each category varied based on participant responses
Medical Condition Other medical condition	86 Participants n=99 Participants • Totals for each category varied based on participant responses
Medical Condition Answer not provided	768 Participants n=99 Participants • Totals for each category varied based on participant responses
Reading/Writing Impairment No	866 Participants n=99 Participants • Totals for each category varied based on participant responses
Reading/Writing Impairment Yes	39 Participants n=99 Participants • Totals for each category varied based on participant responses
Reading/Writing Impairment Answer not provided	6 Participants n=99 Participants • Totals for each category varied based on participant responses
Self-Reported HIV Risk High risk	520 Participants n=99 Participants
Self-Reported HIV Risk Low risk	391 Participants n=99 Participants
Sexual Orientation Heterosexual	606 Participants n=99 Participants • Totals for each category varied based on participant responses
Sexual Orientation Gay/Lesbian	150 Participants n=99 Participants • Totals for each category varied based on participant responses
Sexual Orientation Bisexual	82 Participants n=99 Participants • Totals for each category varied based on participant responses
Sexual Orientation Other	52 Participants n=99 Participants • Totals for each category varied based on participant responses
Sexual Orientation Prefer not to answer	21 Participants n=99 Participants • Totals for each category varied based on participant responses
Tested for HIV Before No	422 Participants n=99 Participants • Totals for each category varied based on participant responses
Tested for HIV Before Yes	479 Participants n=99 Participants • Totals for each category varied based on participant responses
Tested for HIV Before Answer not provided	10 Participants n=99 Participants • Totals for each category varied based on participant responses
Visual Impairment No	604 Participants n=99 Participants • Totals for each category varied based on participant responses
Visual Impairment Yes	301 Participants n=99 Participants • Totals for each category varied based on participant responses
Visual Impairment Answer not provided	6 Participants n=99 Participants • Totals for each category varied based on participant responses

PRIMARY outcome

Timeframe: Outcome measured following POC tests on Visit 1, Day 1 for each participant.

Population: The invalids, inconclusive and not sure/do not know were not included in the calculations of Positive and Negative % Agreement.

Outcome measures

Outcome measures
Measure	Self-testing Participants n=911 Participants Unknown HIV status
Device Performance: Positive and Negative Percent Agreement True Positive	1 Participants
Device Performance: Positive and Negative Percent Agreement False Negative	0 Participants
Device Performance: Positive and Negative Percent Agreement True Negative	880 Participants
Device Performance: Positive and Negative Percent Agreement False Positive	0 Participants
Device Performance: Positive and Negative Percent Agreement Inconclusive	1 Participants
Device Performance: Positive and Negative Percent Agreement Positive % Agreement	1 Participants
Device Performance: Positive and Negative Percent Agreement Negative % Agreement	880 Participants
Device Performance: Positive and Negative Percent Agreement Invalid	20 Participants
Device Performance: Positive and Negative Percent Agreement Not sure/Do not know	9 Participants

PRIMARY outcome

Timeframe: Outcome measured following POC tests on Visit 1, Day 1 for each participant.

Population: Totals for each category varied based on participant responses

Observation to determine if participants perform all critical steps correctly

Outcome measures

Outcome measures
Measure	Self-testing Participants n=906 Expected Responses Unknown HIV status
Observer Usability Assessment Did the study participant read the instructions for use (IFU)? · Expected response	859 Expected Responses
Observer Usability Assessment Did the study participant read the instructions for use (IFU)? · Unexpected response	47 Expected Responses
Observer Usability Assessment Were the instructions for use (IFU) read before the test? · Expected response	701 Expected Responses
Observer Usability Assessment Were the instructions for use (IFU) read before the test? · Unexpected response	205 Expected Responses
Observer Usability Assessment Was the IFU referred to during the test process? · Expected response	864 Expected Responses
Observer Usability Assessment Was the IFU referred to during the test process? · Unexpected response	42 Expected Responses
Observer Usability Assessment Did the study participant remove the contents of the test pack? · Expected response	901 Expected Responses
Observer Usability Assessment Did the study participant remove the contents of the test pack? · Unexpected response	5 Expected Responses
Observer Usability Assessment Was the study participant able to find the test tube packet? · Expected response	905 Expected Responses
Observer Usability Assessment Was the study participant able to find the test tube packet? · Unexpected response	1 Expected Responses
Observer Usability Assessment Did the study participant remove the test tube from the packet? · Expected response	905 Expected Responses
Observer Usability Assessment Did the study participant remove the test tube from the packet? · Unexpected response	1 Expected Responses
Observer Usability Assessment Did the study participant remove the cap from the test tube? · Expected response	896 Expected Responses
Observer Usability Assessment Did the study participant remove the cap from the test tube? · Unexpected response	10 Expected Responses
Observer Usability Assessment Did the study participant place the test tube in the holder? · Expected response	848 Expected Responses
Observer Usability Assessment Did the study participant place the test tube in the holder? · Unexpected response	58 Expected Responses
Observer Usability Assessment Did the study participant have any difficulty with the test tube? · Expected response	731 Expected Responses
Observer Usability Assessment Did the study participant have any difficulty with the test tube? · Unexpected response	175 Expected Responses
Observer Usability Assessment Was the study participant able to find the test stick packet? · Expected response	903 Expected Responses
Observer Usability Assessment Was the study participant able to find the test stick packet? · Unexpected response	3 Expected Responses
Observer Usability Assessment Did the study participant remove the test stick from the packet? · Expected response	902 Expected Responses
Observer Usability Assessment Did the study participant remove the test stick from the packet? · Unexpected response	4 Expected Responses
Observer Usability Assessment Did the study participant touch the flat pad? · Expected response	859 Expected Responses
Observer Usability Assessment Did the study participant touch the flat pad? · Unexpected response	47 Expected Responses
Observer Usability Assessment Did the study participant collect the sample correctly (1x upper and lower swab)? · Expected response	754 Expected Responses
Observer Usability Assessment Did the study participant collect the sample correctly (1x upper and lower swab)? · Unexpected response	152 Expected Responses
Observer Usability Assessment Did the study participant place the test stick in the test tube correctly? · Expected response	889 Expected Responses
Observer Usability Assessment Did the study participant place the test stick in the test tube correctly? · Unexpected response	17 Expected Responses
Observer Usability Assessment Did the participant perform any steps out of the order? · Expected response	800 Expected Responses
Observer Usability Assessment Did the participant perform any steps out of the order? · Unexpected response	106 Expected Responses
Observer Usability Assessment Did the participant miss any step and continue the process despite a missed or incorrect step? · Expected response	860 Expected Responses
Observer Usability Assessment Did the participant miss any step and continue the process despite a missed or incorrect step? · Unexpected response	46 Expected Responses
Observer Usability Assessment Did the participant quit the process at any point? · Expected response	905 Expected Responses
Observer Usability Assessment Did the participant quit the process at any point? · Unexpected response	1 Expected Responses
Observer Usability Assessment Did the study participant wait 20 minutes before reading the results of the test? · Expected response	820 Expected Responses
Observer Usability Assessment Did the study participant wait 20 minutes before reading the results of the test? · Unexpected response	86 Expected Responses

PRIMARY outcome

Timeframe: Outcome measured following POC tests on Visit 1, Day 1 for each participant.

Confirmation by Observer to determine if participant interprets test results correctly and successful interpretation of various contrived (mock) test device results.

Outcome measures

Outcome measures
Measure	Self-testing Participants n=906 Participants Unknown HIV status
Participant and Observer Interpretations Participant & Observer Agreement	884 Participants
Participant and Observer Interpretations Participant & Observer Disagreement	22 Participants

PRIMARY outcome

Timeframe: Outcome measured following POC tests on Visit 1, Day 1 for each participant.

Population: The numbers are based on survey responses which varied across the different survey questions.

To determine that the participant is aware of key messages in labelling including test limitations and what to do following the test result.

Outcome measures

Outcome measures
Measure	Self-testing Participants n=911 Participants Unknown HIV status
Label Comprehension Did you use the Instructions for Use (IFU) sheet to help you complete the test? · Yes	881 Participants
Label Comprehension Did you use the Instructions for Use (IFU) sheet to help you complete the test? · No	22 Participants
Label Comprehension Were the Instructions for Use (IFU) easy to follow? · Yes	878 Participants
Label Comprehension Were the Instructions for Use (IFU) easy to follow? · No	24 Participants
Label Comprehension Were the pictures and illustrations in the Instruction for Use (IFU) helpful? · Yes	878 Participants
Label Comprehension Were the pictures and illustrations in the Instruction for Use (IFU) helpful? · No	24 Participants
Label Comprehension Was the Self-Test easy to use? · Yes	895 Participants
Label Comprehension Was the Self-Test easy to use? · No	7 Participants
Label Comprehension Are you confident you could perform this test on your own? · Yes	899 Participants
Label Comprehension Are you confident you could perform this test on your own? · No	3 Participants
Label Comprehension Would you use this test again if it were available to you? · Yes	882 Participants
Label Comprehension Would you use this test again if it were available to you? · No	20 Participants
Label Comprehension Would you prefer to use this test at home (yes) or get tested at a clinic (no)? · Yes	697 Participants
Label Comprehension Would you prefer to use this test at home (yes) or get tested at a clinic (no)? · No	205 Participants
Label Comprehension Would you recommend this test to others? (e.g. a sexual partner, friend) · Yes	890 Participants
Label Comprehension Would you recommend this test to others? (e.g. a sexual partner, friend) · No	12 Participants

SECONDARY outcome

Timeframe: Outcome measured following mock device interpretation on Visit 1, Day 1 for each participant.

The percentage of correct interpretations of contrived devices compared to the expected results.

Outcome measures

Outcome measures
Measure	Self-testing Participants n=465 In Concordance Unknown HIV status
Readability or Interpretation (Mock Devices) Negative	453 In Concordance
Readability or Interpretation (Mock Devices) Strong positive	418 In Concordance
Readability or Interpretation (Mock Devices) Weak positive	329 In Concordance
Readability or Interpretation (Mock Devices) Invalid, test line present	273 In Concordance
Readability or Interpretation (Mock Devices) Invalid, no control line or test line	448 In Concordance

Adverse Events

Self-testing Participants

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Self-testing Participants n=951 participants at risk Unknown HIV status
Product Issues Buffer solution-soaked swab placed in mouth	0.32% 3/951 • Number of events 3 • Adverse event data were collected over the two week time frame in which the participant completed visit 1 and visit 2.

Additional Information

Sean B. Rourke

Li Ka Shing Knowledge Institute, St. Michael's Hospital

Phone: (416) 878-2779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place