The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities.
The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities. The study aims to recruit 10,000 people who are attending clinics for routine sexually transmitted and blood-borne testing in those provinces with opportunities for them to receive immediate treatment for syphilis, and culturally appropriate care and treatment for syphilis and HIV. The primary objective is develop, implement and evaluate community-based models for "testing, treatment and linkages to care" for HIV and syphilis for those who are undiagnosed and underserved in the Prairie provinces. The secondary objectives are: Evaluate diagnostic performance of the investigational syphilis standalone POC test to standard testing. Test the accuracy and usability of the investigational syphilis standalone POC test by intended users. Assess the impact of POC testing on time to diagnosis, treatment, and connect to a clinical provider. Investigate the feasibility and acceptability of the POC test among healthcare providers and at-risk populations. Examine the acceptability of syphilis and HIV POC tests among at-risk and underserved populations. Critical to the success of this, the study will engage and support people with lived experiences, peer navigators and leaders from community-based agencies to be involved in all aspects of this work.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10,000
The INSTI HIV-1/HIV-2 Antibody Test is a single use, rapid, in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and/or Type 2 (HIV-1/HIV-2) in human venipuncture whole blood, fingerstick blood, or plasma specimens. The test is intended for use by trained personnel in point of care and laboratory situations to aid in the diagnosis of HIV infections. If multiple rapid HIV tests are available, this test is suitable for use in appropriate multi-test algorithms.
The INSTI MULTIPLEX HIV-1/2 Syphilis Ab Test is a single use, rapid, flow-through in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1/ Type 2 and Treponema pallidum in human fingerstick blood and serum. The INSTI Multiplex Test is intended as an aid in the diagnosis of HIV1/2 and Syphilis infections in patients with signs and symptoms of HIV and Syphilis. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as an in vitro diagnostic device capable of providing results in less than one minute. Although suitable for near-patient point-of-care (POC) testing, the INSTI Multiplex Test is not suitable for self-testing.
Radius Community Health & Healing
Edmonton, Alberta, Canada
StreetWorks
Edmonton, Alberta, Canada
Northreach Society
Grande Prairie, Alberta, Canada
Siloam Mission
Winnipeg, Manitoba, Canada
Proportion of True Positives and True Negatives in Point-of-Care Syphilis Testing Compared to Standard Laboratory Testing (Sensitivity and Specificity Analysis)
Diagnostic performance of POC T Pallidum antibody and non-T Pallidum antibody test results will be compared to standard laboratory testing results for each marker, and test performance characteristics with 95% binomial confidence intervals will be calculated for sensitivity and specificity. In addition, diagnostic performance for TP antibody detection will be stratified by RPR titre (non-reactive, 1:1, 1:2, 1:4, \>1:8 dilutions). Serial, parallel serology will be collected at the time of every syphilis POCT. Serology is the gold standard to diagnose syphilis and aids in determining staging and thus, treatment. Serial testing will aid whether syphilis POCT may be utilized in a more comprehensive manner, to possibly replace serology in some settings where access may be a challenge.
Time frame: 3 years
Time to Diagnosis, Treatment, and Linkage to HIV Care Following Point-of-Care Testing vs. Standard Testing
Assess the time to diagnosis, time to treatment, and time to HIV care linkage following point-of-care testing for syphilis and HIV compared to standard laboratory testing. Time to diagnosis and treatment will be measured in days from test administration to diagnosis and from diagnosis to treatment, respectively. For HIV, time to linkage to care will be measured in days from diagnosis to first consultation with an infectious disease specialist. Data will be stratified by age, gender, and testing location, and analyzed using survival analysis or Poisson/negative binomial regression. Comparisons will be made between POC and standard testing with statistical significance determined by a p-value of \<0.05.
Time frame: 3 years
Proportion of Patient Consenting vs. Declining (Patient Acceptability of Point-of-Care Testing )
To evaluate the acceptability and feasibility of POC among different populations for syphilis (and HIV if applicable) among at risk and underserved populations, specifically patient acceptability and experiences with POC. Patient acceptability will be calculated as the proportion of individuals consenting to POCT divided by the total number of participants offered POC testing. To determine differences between participants consenting and those declining POC testing, age, gender, and testing location will be compared using chi-square for categorical variables and Mann-Whitney U test for age. A two-sided p value of \< 0.05 will be considered statistically significant.
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Multiplo Complete Syphilis (TP/nTP) Antibody Test (Multiplo® TP/nTP) is a single use, manually performed, visually interpreted, qualitative immunoassay based on Rapid Vertical Flow Technology® for the detection of antibodies to Treponema pallidum (TP), the causative agent of syphilis, and to nontreponemal (nTP; \[RPR titer ≥ 1:8\]) antigens in human serum, plasma, or fingerstick whole blood specimens. Nontreponemal antibodies are called reagins and they are generated after the tissue damage caused by syphilis infection. Multiplo® TP/nTP is intended for use by healthcare professionals as an aid in the diagnosis of active syphilis infection.
Ka Ni Kanichihk
Winnipeg, Manitoba, Canada
Nine Circles Community Health Centre
Winnipeg, Manitoba, Canada
All Nations Hope Network
Regina, Saskatchewan, Canada
Wellness Wheel Clinic
Regina, Saskatchewan, Canada
Time frame: 3 years
Descriptive Analysis of Healthcare Provider Feasibility and Acceptability of Point-of-Care Testing
Healthcare providers will complete a survey after point-of-care testing assessing their experience using the test (e.g., ease of use, ease of interpretation of results). A descriptive analysis of healthcare provider experience survey will be conducted.
Time frame: 3 years
Descriptive Analysis of Patient Experience and Satisfaction of Point-of-Care Testing
Patients will complete a survey after point-of-care testing assessing their experience (e.g., comfort levels, recommend to others, ease of testing process). A descriptive analysis of the patient experience survey will be completed and stratified by negative and positive results by test type.
Time frame: 3 years
Demographic Associations with Syphilis and HIV Point-of-Care Test Outcomes (Reactive vs. Non-Reactive Results)
Analyze the associations between demographic factors (such as age, gender, and testing location) and syphilis and HIV point-of-care test outcomes, focusing on the correlation between demographics and reactive versus non-reactive test results. Chi-square analysis will be used to assess these associations, with stratification by POC test type when sample sizes allow. A two-sided p-value of \<0.05 will be considered statistically significant.
Time frame: 3 years