HIV Prevention Toolkit for HIV-negative Male Couples (MCAP)
2019年3月28日 更新者:Daniel J Feaster、University of Miami
Development of a HIV Prevention Toolkit for At-risk HIV-negative Male Couples
Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design.
Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules.
The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples.
For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project.
After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples.
The interactive website, herein referred to as the "HIV prevention toolkit" will contain unique modules about sexual agreements and effective HIV prevention strategies.
研究概览
研究类型
介入性
注册 (实际的)
298
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Miami、Florida、美国、33136
- Clinical Research Building
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
Eligible male couples:
- are identified as two men (i.e., main partners) who had been in a sexual relationship together for > 6 months;
- are at least 18 years of age;
- are self-reported as being HIV-negative;
- had been practicing CAS in their relationship for > 6 months;
- report no recent history (< 1 year) of intimate partner violence (IPV) or coercion;
- have had no current sexual agreement; and
- own a smartphone and have an alternate method to access the Internet (e.g., computer).
Exclusion Criteria:
- Interested participants, including both men of a male couple, who did not meet the inclusion criteria above will be excluded from participating in Phase 3 of this study.
- Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
- Adults who are unable to consent;
- Individuals who are not yet adults;
- Pregnant and non-pregnant women, and prisoners.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:Control group
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
|
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
|
|
有源比较器:Intervention group
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
|
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Formation of a Sexual Agreement at 6 Months
大体时间:6 month
|
Self-reports of yes/no to forming a sexual agreement via electronic survey
|
6 month
|
|
Adherence to a Sexual Agreement at 6 Months
大体时间:6 month
|
Self-report of yes/no of adhering to a sexual agreement
|
6 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Formation of a Sexual Agreement at 3 Months
大体时间:3 month
|
Self-reports of yes/no to forming a sexual agreement via electronic survey
|
3 month
|
|
Adherence to a Sexual Agreement
大体时间:3 month
|
Self-reports of yes/no to adhering to a sexual agreement via electronic survey
|
3 month
|
|
Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
大体时间:3 month
|
Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey
|
3 month
|
|
Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
大体时间:month 6
|
Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6).
|
month 6
|
|
Test for HIV During Past 3 Months (Months 0-3)
大体时间:3 month
|
Self-reports of yes/no via electronic survey taken at 3 month.
|
3 month
|
|
Test for HIV During the Last 3 Months (Months 3-6)
大体时间:month 6
|
Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.
|
month 6
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jason W Mitchell, PhD、University of Miami
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年10月1日
初级完成 (实际的)
2016年9月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2015年7月7日
首先提交符合 QC 标准的
2015年7月7日
首次发布 (估计)
2015年7月10日
研究记录更新
最后更新发布 (实际的)
2019年4月16日
上次提交的符合 QC 标准的更新
2019年3月28日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
其他研究编号
- 20140561
- R34MH102098 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.