Addressing Factors Related to Disparities in Vasectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Participant knowledge about vacectomy
研究概览
简要总结
The goal of this trial is to learn if a web-based decision aid designed to provide evidence-based information about vasectomy and other birth control options helps improve users' decision-making about birth control. The main questions it aims to answer are:
- Do people who use the decision aid have better knowledge about vasectomy?
- Do people who use the decision aid have lower conflict with their decision?
Participants will:
- Use the decision aid (if they are assigned to the intervention arm).
- Answer survey questions about their knowledge, decision-making, interest in vasectomy, and healthcare navigation experiences.
详细描述
This study seeks to test a web-based decision support tool developed to enhance men's ability to make informed decisions about vasectomy that align with their preferences, values and reproductive goals. Half of participants will take their T1 survey immediately following randomization, while the other half will first use the web-based decision aid. The investigators hypothesize that compared to men who do not use the decision aid, men randomized to the decision aid arm will have greater knowledge about vasectomy and alternative options, lower decisional conflict, and will report greater interest in getting a vasectomy.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Are assigned male at birth
- •21-55 years of age
- •Comfortable reading in English or Spanish
- •Live in the United States
- •Are considering vasectomy
- •Have not had a vasectomy
排除标准
- •Are not assigned male at birth
- •Are less than 21 or more than 55 years of age
- •Is not comfortable reading English nor Spanish
- •Do not live in the United States
- •Are not considering vasectomy
- •Have had a vasectomy
- •Once a racial or economic sub-group recruitment number has been reached, no other subjects fitting that ethnicity or income group will be enrolled.
研究组 & 干预措施
Decision Aid Arm
Participants will use the web-based decision aid.
干预措施: "Vasectomy: Right for Me?" decision aid (Behavioral)
Control Arm
Participants will be asked to take their T1 survey directly after randomization, without using the decision aid.
结局指标
主要结局
Participant knowledge about vacectomy
时间窗: Up to 45 minutes
Participant responses to 10 True/False items adapted from previously published studies of vasectomy knowledge and informed by in-depth interviews with men about vasectomy decision making. Items assess knowledge about vasectomy and alternative contraception options and will be coded as correct vs. incorrect, with "Don't Know" being coded as an incorrect response. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%.
Participant decisional conflict in contraceptive choice
时间窗: Up to 45 minutes
Assessed by participant responses to the low literacy version of the Decisional Conflict Scale (DCS). The DCS is a validated measure to assess participants' decisional conflict in medical decision-making. The DCS low literacy version includes 10 items about experience of conflict, with "Yes" = 0, "unsure" = 2 and "No" = 4. All 10 items are a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
次要结局
- Interest in vasectomy(Up to 45 minutes)
研究者
Sonya Borrero
Professor of Medicine
University of Pittsburgh