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临床试验/NCT04836091
NCT04836091已完成不适用

A Patient-centered Decision Aid to Inform HIV Prevention Choices for At-risk Male Couples in New Relationships

Florida International University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年3月16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
84
试验地点
2
主要终点
Change in presence of a detailed risk-reduction plan

研究概览

简要总结

The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples' self-reported sexual health and prevention behaviors, beliefs, and attitudes. The study will enroll both men of the couple into a randomized controlled trial. Participants/couples randomized to the intervention will have access to the app for two months while those assigned to the waitlist group will receive and have access to the app for one month. Participants will complete surveys at baseline and at month 2.

详细描述

The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples' self-reported sexual health and prevention behaviors, beliefs, and attitudes. The study will enroll both partners of the 42 male couples into a 2-month randomized controlled trial with a waitlist control condition of one month. Couples will be assigned to either the immediate intervention group ("intervention arm") or the waitlist-control group ("waitlist-control arm"). All participants will take an assessment survey at baseline, and the intervention group will be oriented on the installation and use of the app upon randomization to that group. The waitlist-control group will follow the same procedures one month later. Participants/couples randomized to the intervention arm will have access to the intervention app for two months (ie, day 1-60) while those assigned to the waitlist-control group will have access to the app for one month (ie, day 31-60). All participants in the randomized controlled trial will complete a short follow-up survey at month 2 and a brief exit interview.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Does not meet one or more the inclusion criteria

结局指标

主要结局

Change in presence of a detailed risk-reduction plan

时间窗: Baseline, month 2

Men will be asked if they created a detailed risk-reduction plan containing evidence-based strategies of routine HIV/STI testing, consistent condom use, PrEP, and ART

Change in number of evidence-based prevention strategies being used over time

时间窗: Baseline, month 2

Men will be asked how many evidence-based HIV/STI prevention strategies they are currently using

Change in willingness to use evidence-based prevention strategies over time

时间窗: Baseline, month 2

Men will be asked about their willingness to use evidence-based prevention strategies

Change in intention to use evidence-based prevention strategies over time

时间窗: Baseline, month 2

Men will be asked about their intention to use evidence-based prevention strategies

次要结局

  • Change in HIV transmission and prevention knowledge(Baseline, month 2)
  • Change in goal congruence on sexual health(Baseline, month 2)
  • Change in mutual constructive communication(Baseline, month 2)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jason Mitchell

Associate Professor

Florida International University

研究点 (2)

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