The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders (Project WORTH)
2014年2月25日 更新者：Nabila El-Bassel, PhD、Columbia University
Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision.
This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.
研究概览
详细说明
While it is clear that women inmates in jails and prisons bear a high burden of Human immunodeficiency virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), the effective development of prevention interventions for this high-risk group require an understanding of HIV risk context, sexual behaviors and attitudes for women while they are still in the community and before they become heavily involved in the criminal justice system.
HIV prevention interventions must focus on women at early points of entry into the criminal justice system, when they are still in the community and at higher risk of engaging in unsafe sex and drug behaviors.
This study focuses on a population of drug-involved women who have been arrested and given a court sanction, but are still living in the community.
研究类型
介入性
注册 (实际的)
306
阶段
- 阶段2
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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New York
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New York、New York、美国、10027
- Columbia University School of Social Work
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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
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- She is 18 or older.
- She is currently supervised by a criminal justice entity, such as a community court or probation.
- She reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days
- She reports any illicit drug use or binge drinking in the past 6 months.
Exclusion Criteria:In addition, potential participants will be ineligible if any of the following criteria are met:
- Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
The woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional HIV risk behaviors in the past 90 days:
- Having sex with more than one partner
- Having sex with a partner known or suspected to be HIV positive or an injection drug user (IDU)
- Sharing injection drug use needles or equipment
- The woman is actively trying to get pregnant/have a baby.
- Inability to complete informed consent process due to a psychiatric or cognitive impairment.
- The participant was born male.
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 |
|---|---|
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实验性的：Multimedia HIV/STI prevention
Multimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.
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The Multimedia WORTH intervention features the same core elements as the original version, but these core elements are translated into interactive tools and culturally tailored video vignettes designed to enhance group learning and individualized feedback. Participants will interact with Multimedia WORTH at two levels: (1) group materials will be delivered via computer projection onto a screen and (2) participants will complete individual activities and create journal logs tracking their progress on personalized goals on their personal user accounts using laptop computers. The computer multimedia support tool includes text, imagery, animations, audio and video in a format that guide the facilitator's delivery of the intervention. ***To view pilot features of the Multimedia WORTH intervention in development, please visit the following web address: http://ccnmtl.columbia.edu/projects/worth/presentation |
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有源比较器：Traditional HIV/STI prevention
Traditional WORTH is a 4-session group-based HIV/STI and drug abuse prevention intervention that covers the same content as Multimedia WORTH without the use of interactive videos, computerized assessments, and other audiovisual tools.
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The basic format of each WORTH session remains consistent following a sequence of 5 steps: (1) an opening (quote, song, poem) which will provide a brief culturally relevant point of inspiration to engage participants (2) Check-in to review material from the previous session, and to discuss any incidents where participants engaged in risk behaviors and to acknowledge positive ways in which women used new skills to avoid HIV risk; (3) a discussion to raise awareness of links between IPV, drug-related activities, and HIV risks; (4) a skills-building component relevant to the discussion; and (5) review and update participant needs, homework assigned for skills-building at home, and a closing ritual.
The WORTH intervention consists of four 2-hour group sessions that are led by a female facilitator.
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安慰剂比较：Wellness Promotion
Wellness Promotion is a 4-session group based intervention that aims to improve diet, physical fitness and well-being which is designed as an attentional control condition.
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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 |
|---|---|
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The proportion of condom protected acts of vaginal and anal intercourse
大体时间：Up to 12 months
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Up to 12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)
大体时间：Up to 12 months
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Up to 12 months
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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：Nabila El-Bassel, Ph.D.、Columbia University
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。
一般刊物
- Hochstatter KR, Slavin MN, Gilbert L, Goddard-Eckrich D, El-Bassel N. Availability of informal social support and the impact on health services utilization among women in community corrections who engage in substance use and risky sexual behavior: New York City, 2009-2012. Health Justice. 2022 Feb 16;10(1):6. doi: 10.1186/s40352-022-00170-0.
- El-Bassel N, Gilbert L, Goddard-Eckrich D, Chang M, Wu E, Hunt T, Epperson M, Shaw SA, Rowe J, Almonte M, Witte S. Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH. PLoS One. 2014 Nov 5;9(11):e111528. doi: 10.1371/journal.pone.0111528. eCollection 2014.
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
2009年11月1日
初级完成 (实际的)
2013年3月1日
研究完成 (实际的)
2013年3月1日
研究注册日期
首次提交
2013年2月4日
首先提交符合 QC 标准的
2013年2月5日
首次发布 (估计)
2013年2月6日
研究记录更新
最后更新发布 (估计)
2014年2月27日
上次提交的符合 QC 标准的更新
2014年2月25日
最后验证
2014年2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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