Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Unable to speak and understand English
结局指标
主要结局
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.
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Tasha Ramsey
Co-Principal Investigator
Nova Scotia Health Authority