Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Compliance with self-test execution
研究概览
简要总结
It concerns a study to evaluate the usability of an HIV self-test prototype developed from TR DPP® HIV - 1/2 Oral Fluid. The study followed the recommendations of Technical Note No. 20/2016 / GEVIT / GGTPS / ANVISA.
详细描述
It concerns a study with a mixed method approach to evaluate the usability of a prototype of HIV self-test among lay users. Data collection techniques were performed through observation through videos of lay users conducting self-testing without supervision, a qualitative checklist by participant observation, pre-test and post-test interviews, and closure form. There was no randomization in this study.
The study was conducted by four clinical research sites, distributed in four different states of Brazil in other to obtain a geographic representation: Unidade de Ensaios Clínicos para Imunobiológicos (UECI) at Rio de Janeiro; Centro de Ciências da Saúde da Universidade Federal da Paraíba (UFPB) at Paraíba, Faculdade de Medicina de Botucatu (UNESP) at São Paulo and Centro de Ciências Biológicas e da Saúde da Universidade Estadual do Pará (UEPA) at Pará.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Individuals aged ≥ 18 years, of both sexes, who agree to participate in the study, after reading, understanding and signing the ICF;
- •Individuals who authorized filming during the test.
排除标准
- •Illiterates;
- •Participants who have already performed any other HIV self-test;
- •Health professionals with complete higher education;
- •Colorblind individuals.
结局指标
主要结局
Compliance with self-test execution
时间窗: Day 1
Percentage of participants who followed all the steps correctly
Compliance with results interpretation
时间窗: Day 1
Percentage of participants who misinterpreted the test result
Compliance with self-test result
时间窗: Day 1
Percentage of positive results interpreted as negative
Compliance with self-test steps
时间窗: Day 1
Percentage of participants who made mistakes in each of the steps
次要结局
未报告次要终点