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临床试验/NCT04061915
NCT04061915已完成不适用

HIV Oral Testing Infographic Experiment (HOTIE)

New York University1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2019年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
322
试验地点
1
主要终点
HIV Self-testing Knowledge

研究概览

简要总结

Premised on the National AIDS Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose of this formative pilot study is to develop and test an integrated HIV self-testing strategy that utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual minority men of color.

详细描述

In the United States, approximately 1.1 million persons are living with HIV. Despite novel pharmacological breakthroughs, comprehensive models of health care, and targeted HIV testing initiatives, over 160,000 persons are still unaware of their HIV serostatus. Emerging adult, sexual minority, men of color are disproportionately affected. Premised on the National AIDS Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose of this formative pilot study is to develop and test an integrated HIV self-testing strategy that utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual minority men of color.

The overall study will focus on: (a) understanding facilitators and barriers to HIV self-testing among emerging adult MSM, (b) designing a HIV self-testing infographic that utilizes a simplicity model, (c) finalizing the HIV self-testing infographic with input from a leadership group of HIV community members, (d) conducting a pilot clinical trial with 300 emerging adult (ages 18-34), sexual minority, men of color to test if a collaboratively-designed HIV self-testing infographic can facilitate accurate and effective understanding of how to self-test for HIV when compared to paper-based, HIV self-testing information.

By conducting this study, we will gain beneficial insights necessary for presenting HIV self-testing instructions in a meaningful, relevant, and comprehensible way. The results of this pilot study have the potential to inform strategies regarding how self-testing instructions can be worded or visually presented in order to break both literacy and language barriers that affect testing utilization and results accuracy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Understand and read English
  • Assigned male sex at birth
  • Self-identify as gay, same-gender-loving, or MSM
  • Self-report being HIV-negative or unknown HIV serostatus

排除标准

  • Persons with a known HIV diagnosis

结局指标

主要结局

HIV Self-testing Knowledge

时间窗: 1 day

Self-report comprehension questionnaire based on accurate completion of HIV-self testing steps. Measure of participants understanding of the text and pictures on how to perform an HIV self-test. Questions asked about using the test stick, oral swabbing, what to do with the test stick after swabbing, minutes of wait time before interpretation of result, comprehension of result. Range: 0 to 5 (5 indicates all correct responses)

Usefulness, Ease of Use, Ease of Learning and Satisfaction of the HIV Self-testing Infographic

时间窗: 1 day

USE Questionnaire: Usefulness, Satisfaction, and Ease Measures the subjective usability of the HIV self-testing infographic. We used 14-items, using a 7-point Likert, and the minimum score is 14 and maximum 98 to examine dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. Scores for each dimension are averaged together to get a composite score.We report the overall usability of the infographic.

次要结局

  • Health Literacy(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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