A Prospective Cross-Sectional Study to Evaluate Performance and Usability of Multiplo® TP/HIV Test at Point-Of-Care Sites in the Hands of Untrained Non-Health Care Professional Operators
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 800
- 试验地点
- 8
- 主要终点
- Percent positive and negative agreement of the Multiplo® TP/HIV Test performed by non-healthcare providers to the Participant's HIV and/or syphilis status confirmed by the lab results.
研究概览
简要总结
To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Inc. (Halifax, NS, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood samples that is seeking approval from Health Canada for use by trained healthcare professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.
详细描述
This is a blinded, controlled study to evaluate the ability of the Operators, including peer testers, to perform and interpret the HIV and Syphilis results of the Multiplo TP/HIV Test. The non-registered health care professionals including peer testers are defined as non-health care professional (ie. Peers) paid site personnel that have no training or hands-on experience with the Multiplo Test. This protocol involves collection of fingerstick whole blood from a minimum of 800 Participants to test with the Multiplo Test. Testing will be conducted by the study Operators in near-patient clinical settings. Results from the Multiplo Test will be compared to results from blood based serological assays, including licensed 4th generation HIV EIA and syphilis EIA/RPR assays. Study Operator qualifications and assessment of the ease of device use will be evaluated. Operators will also read and interpret various contrived devices in order to assess their ability to correctly interpret a variety of potential test results.
All enrolled Participants will voluntarily provide medical history and the specimens according to Section 4, Study Procedures at Visit 1 (Day 1), for the testing with the Multiplo Test.
All Participants will have a laboratory test done for performance comparison, but only those with unknown HIV and/or syphilis status will be instructed to return to the clinic for a follow-up visit (Visit 2), two (2) weeks later to obtain their laboratory test results. Participants may also have a separate Point-of-Care (POC) test for HIV and/or syphilis conducted on site as part of the clinic's standard of care testing, outside of the protocol.
Activities in the plan of the study include:
- Selection of study Operators with informed consent for participation in the study
- Completion of Untrained Operator Eligibility and Assessment Questionnaire - prior to study start
- Screening of participants and obtaining informed consent
- Review of inclusion/exclusion criteria and completion of Participant Enrollment Questionnaire
- Specimen Collection and Testing:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
blinded study design involving participants with known and unknown syphilis and HIV status where test providers are blinded to the participant status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percent positive and negative agreement of the Multiplo® TP/HIV Test performed by non-healthcare providers to the Participant's HIV and/or syphilis status confirmed by the lab results.
时间窗: 6 months
The primary outcome for the study will be the percent positive and negative agreement of the Multiplo® TP/HIV Test performed by intended, untrained users to the Participant's HIV and/or syphilis status confirmed by the lab results. The percentages for positive and negative agreement will be calculated with the two-sided 95% confidence intervals for both as follows: % Positive Agreement= ((n) HIV or syphilis Multiplo reactive results )/((n) HIV or syphilis positive status)×100 % Negative Agreement= ((n)HIV or syphilis Multiplo non reactive results )/((n) HIV or syphilis negative status)×100 Percent positive and negative agreement will be calculated for each analyte (HIV or syphilis) separately.
次要结局
- Percent of correctly interpreted mock devices by untrained, non-healthcare professional operators(6 months)