Implementation of an Efficacious Intervention for High Risk Women in Mexico
2015年5月26日 更新者：Thomas L. Patterson、University of California, San Diego
This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs).
Taking a brief, single-session counseling program (called "Mujer Segura") that has been proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities along the U.S. border, this project will study the implementation of the program in CBOs in 12 additional cities throughout Mexico to determine how best to ensure that the program remains true to the original model and retains its effectiveness.
Mexico has been chosen because HIV is a global problem that respects no international borders, and because HIV prevention programs that can be implemented in settings with limited resources are urgently needed in many parts of the world.
研究概览
研究类型
介入性
注册 (实际的)
1228
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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Veracruz、墨西哥、91910
- CSM Veracruz
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D.f.
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Mexico City、D.f.、墨西哥、06080
- Centro de Servicios Medicos (CSM) Revolucion
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Jalisco
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Guadalajara、Jalisco、墨西哥、44270
- CSM Guadalajara
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Veracruz
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Naranjos、Veracruz、墨西哥、92300
- CSM Naranjos
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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
女性
描述
Inclusion Criteria:
- At least 18 years of age
- Self-identify as female sex worker
- Exchanged sex for money, drugs, shelter, or other benefit in last 2 months
- Had unprotected anal or vaginal sex with male client at least once in last 2 months
- Agree to be tested for HIV & STIs at baseline and 6-month follow-u0
Exclusion Criteria:
- Previous positive HIV test result
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：卫生服务研究
- 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：Theory-based counseling (Mujer Segura)
Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
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Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).
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有源比较器：CENSIDA counseling program (didactic)
Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
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Didactic HIV and STI counseling involving some personal risk assessment and presenting appropriate information on methods of transmission and for avoiding or reducing the risk of infection.
Based on a counseling manual disseminated by CENSIDA, Mexico's federal HIV-AIDS prevention agency.
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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 |
|---|---|---|
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Reduction in HIV and STI incidence relative to control group
大体时间：6 months
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Female sex worker (FSW) participants will be tested at baseline and 6-month follow-up for HIV, syphilis, gonorrhea, and Chlamydia.
Incidence rates for all infections at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
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6 months
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Reduction in number of unprotected sex acts relative to control group
大体时间：6 months
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Female sex worker (FSW) participants will be assessed at baseline and 6-month follow-up using self-report measures of frequency of protected and unprotected sex acts with male clients.
Changes in frequency at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fidelity to Mujer Segura intervention model
大体时间：6 months
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Counselors at each CBO will be assessed for their fidelity to the intervention protocol and assigned a numerical score.
This number will be used to determine possible correlations between levels of fidelity and the efficacy of the Mujer Segura intervention at each clinic.
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6 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。
调查人员
- 首席研究员：Thomas L Patterson, Ph.D.、University of California, San Diego
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
- Pitpitan EV, Semple SJ, Aarons GA, Palinkas LA, Chavarin CV, Mendoza DV, Magis-Rodriguez C, Staines H, Patterson TL. Factors associated with program effectiveness in the implementation of a sexual risk reduction intervention for female sex workers across Mexico: Results from a randomized trial. PLoS One. 2018 Sep 11;13(9):e0201954. doi: 10.1371/journal.pone.0201954. eCollection 2018.
- Patterson TL, Semple SJ, Chavarin CV, Mendoza DV, Santos LE, Chaffin M, Palinkas LA, Strathdee SA, Aarons GA. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors. Implement Sci. 2012 Oct 29;7:105. doi: 10.1186/1748-5908-7-105.
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
2011年11月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2011年11月2日
首先提交符合 QC 标准的
2011年11月4日
首次发布 (估计)
2011年11月6日
研究记录更新
最后更新发布 (估计)
2015年5月27日
上次提交的符合 QC 标准的更新
2015年5月26日
最后验证
2015年5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.