About this trial
The goal of this cross-sectional study is to learn if the GeneXpert system is a practical system for HIV and STBBI testing in community-based organizations and health clinics. The study involves a clinical trial to learn if the HIV-1 Qual XC test works to identify HIV in near-patient settings. The main questions it aims to answer are to create a near-patient testing model for testing and treating patients in a single visit, and to learn if the HIV-1 Qual XC test works to accurately detect HIV in patients. Patients who come to study sites to ask for HIV or STBBI testing will be given the option to participate in the study. Those who agree with provide samples for the tests of their choice and answer survey questions before and after their tests are completed. Those who participate in the clinical trial will have a blood sample sent to provincial labs to compare the results to the HIV -1 Qual XC test. Follow-up visits will be done at 1,3 and 6 months to see if patients completed treatment and/or remained connected to care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals accessing STBBI testing at specific locations who are ≥ 16 years of age
Able to provide informed consent.
Disqualifiers
Unable to provide signed informed consent (e.g., intoxicated)
In the opinion of the site PI /study operator, the participant is unable to complete the study elements.
Participants who have previously enrolled in the study.
Trial design
Single group
Treatments tested in this trial
Xpert® HIV-1 Qual XC
DeviceXpert® HIV-1 Qual XC: Xpert HIV-1 Qual XC (extended coverage) is an in vitro nucleic acid amplification test for the qualitative detection of HIV-1 total nucleic acids, on the automated GeneXpert® system. Xpert HIV-1 Qual XC is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other point-of-care and laboratory markers in infant, adolescent, and adult populations. It is a molecular point-of-care test that delivers actionable results in around 90 minutes. The HIV-1 Qual XC assay uses reverse transcription polymerase chain reaction (RT-PCR) technology to achieve high sensitivity for the qualitative detection of HIV-1 total nucleic acids in WB or DBS specimen types.
Treatment groups
Trial outcomes
Primary outcomes
Descriptive analysis of patient and site acceptability of GeneXpert testing
Patients will complete a survey after GeneXpert 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. Site staff will complete a survey after GeneXpert 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.
Proportion of True Positives and True Negatives in GeneXpert HIV-1 Qual XC testing to Standard Laboratory Testing (Sensitivity and Specificity Analysis)
The primary analyses will be positive and negative percent agreement (PPA, NPA) of the Xpert HIV-1 Qual XC results compared to the cobas®HIV-1/HIV-2 QUALITATIVE/cobas®5800 system. The 95% confidence interval will also be determined by the Wilson Score Method. PPA = \[TP / (TP + FN)\] x 100, where TP (true positive) is positive Xpert HIV-1 Qual XC Test in agreement with cobas® HIV-1/HIV-2 QUALITATIVE reactive and FN (false negative) is negative Xpert HIV-1 Qual XC Test discordant with cobas® HIV-1/HIV-2 QUALITATIVE reactive. NPA = \[TN / (TN + FP)\] x100, where TN (true negative) is negative Xpert HIV-1 Qual XC Test in agreement with non-reactive cobas® HIV-1/HIV-2 QUALITATIVE and FP (false positive) is positive Xpert HIV-1 Qual XC Test discordant with cobas® HIV-1/HIV-2 QUALITATIVE non-reactive.
Secondary outcomes
Time to Diagnosis following Point-of-Care Testing vs. Standard Testing
Chi-square analysis will be used to assess the time to diagnosis relative to standard testing. A two-sided p value of \< 0.05 will be considered statistically significant.
Matrix Equivalency: Proportion of True Positives and True Negatives across sample types
EDTA whole blood DBS, capillary EDTA whole blood DBS, and direct fingerstick blood DBS will be determined with a 95% confidence interval calculations (Wilson score interval). A paired-samples T-test will be performed on the HIV-1 positive paired specimens to compare the mean HIV-1 Ct values between capillary and venous WB. Acceptance criteria: Following CLSI guideline EP35 Edition 1 Assessment of Equivalence or suitability of specimen types for medical laboratory measurement procedures, venous EDTA whole blood DBS, capillary EDTA whole blood DBS, and direct fingerstick blood DBS shall have a Positive Percentage Agreement (PPA) and Negative Percentage Agreement (NPA) \> 95%. There should be no significant difference (p \>0.05) in mean HIV-1 Ct value between HIV-1 positive matching DBS specimens using paired T tests.
Time to treatment or time linkage to HIV care following Point-of-Care Testing vs. Standard Testing
Time to treatment or linkage to HIV care will be examined with chi-square analysis applied to assess categorical variables where appropriate. A two-sided p value of \< 0.05 will be considered statistically significant.
Sponsors and contacts
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