Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE)
2010年3月10日 更新者:Medical College of Wisconsin
Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment
The purpose of this study to conduct a small randomized control trial to compare the relative effectiveness of a single-session of HIV testing and counseling risk reduction intervention (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a theory-based and culturally-tailored group-level intervention designed to reduce or eliminate HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men (AA-MSM).
研究概览
详细说明
The HCT-plus intervention will consist of the HCT-only intervention, as well as 8 small group intervention sessions focused on HIV risk reduction.
Small groups will consist of 10 men who will meet once-a-week for 8 consecutive weeks.
Each meeting will last approximately 2 hours.
In each small group session, staff will work with men to reassess their HIV risk behavior, re-prioritize their goals as appropriate, and provide motivational support for their risk reduction accomplishments.
Participants will be asked to discuss ways they have successfully avoided HIV risk behavior since the previous session, as well as to discuss situations in which they found it difficult to avoid risk.
Staff will reinforce successful risk avoidance, and problem-solve with men to overcome barriers to risk reduction.
研究类型
介入性
注册 (预期的)
220
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
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Wisconsin
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Milwaukee、Wisconsin、美国、53202
- Diverse and Resilient
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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
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- reside in Milwaukee county;
- are at least 18 years of age;
- self-identify as male;
- self-identify as Black or African-American;
- can provide informed consent;
- report unprotected anal sex with a man in the past 3 months;
- report at least two sexual partners with whom they have had unprotected anal or vaginal sex in the past 3 months;
- are willing to be tested for HIV using rapid oral fluid procedures or willing to provide evidence of HIV seropositivity
Exclusion Criteria:
- Under 18 years of age,
- involvement in a HIV prevention study currently or in the past 6 months,
- Participation in the pilot phase
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:1
Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
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Participants will receive HIV counseling and testing.
Those selected for the intervention arm will attend small groups consisting of 10 men who meet once a week for 8 consecutive weeks.
The weekly two hour discussion sessions will address HIV risk behavior within a framework of contextual influences that may moderate men's risk reduction motivation and behavior.
The factors include identity, stigma, connections to community, and situation factors.
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无干预:2
Participants receive HIV counseling and testing only.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse.
大体时间:3 months after completing intervention
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3 months after completing intervention
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次要结果测量
结果测量 |
大体时间 |
---|---|
The HCT-plus intervention will result in a smaller proportion of men who had an act of anal or vaginal intercourse without the use of a condom.
大体时间:3 months after completing the intervention
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3 months after completing the intervention
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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。
合作者
调查人员
- 首席研究员:David Seal, PhD、Medical College of Wisconsin
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
2008年6月1日
初级完成 (实际的)
2010年3月1日
研究完成 (实际的)
2010年3月1日
研究注册日期
首次提交
2008年6月3日
首先提交符合 QC 标准的
2008年6月4日
首次发布 (估计)
2008年6月5日
研究记录更新
最后更新发布 (估计)
2010年3月11日
上次提交的符合 QC 标准的更新
2010年3月10日
最后验证
2010年3月1日
更多信息
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.
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Hospital Clinic of Barcelona完全的
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
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Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
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ABLE Human Motion S.L.Institut Guttmann; Heidelberg University Hospital Spinal Cord Injury Center完全的
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London School of Hygiene and Tropical MedicineChildren's Investment Fund Foundation; Splash完全的
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University of California, RiversideAmerican Psychological Foundation未知
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McMaster UniversityMcMaster Institute for Research on Aging; Physiotherapy Foundation of Canada未知肌肉无力 | 老化 | 落下 | 行动不便