Evaluation of a Contraceptive Counseling Intervention in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial (SIRIAN)
2016年6月30日 更新者：Elia Diez David、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Evaluation of a Counseling Intervention to Improve Contraceptive Use in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial.
This study evaluates the effects of a community-based counseling intervention to improve contraception among residents in two deprived neighborhoods in Barcelona (Spain).
Half of the participants received contraceptive counseling at the community setting, while the other half acted as a control group.
研究概览
详细说明
To evaluate the effects of a community-based counseling intervention to improve contraception among residents in deprived neighborhoods a randomized controlled trial is performed.
Women aged 14-49 years and men aged 14-39 years from two low income neighborhoods in Barcelona (Catalonia, Spain) who had not undergone an irreversible contraceptive method and aren't planning a pregnancy have been recruited in 2011-13.
The intervention consists of a culturally developed and theoretically-based brief counseling in community settings.
The primary outcome is the consistent use of very effective contraceptive methods (optimal use).
Secondary outcomes analyzed are the incorrect use of very effective contraceptive methods and use of less effective methods stratified by sex and migrant status.
Differences within subgroups from baseline to 3 months - follow up are analyzed and intervention effects are assessed with adjusted robust Poisson regressions.
研究类型
介入性
注册 (实际的)
500
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
-
-
Catalonia
-
Barcelona、Catalonia、西班牙、08023
- Agència de Salut Pública de Barcelona
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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
14年 至 49年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Women living in the selected neighbourhoods aged 14-49 years
- Men living in the selected neighbourhoods aged 14-39 years
Exclusion Criteria:
- Having undergone an irreversible contraceptive method
- Whishing or planning a pregnancy in the next year
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 |
|---|---|
|
实验性的：Intervention
Contraceptive counseling
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A culturally adapted counselling session lasting up to 45 minutes at the community setting.
The interview is based in WHO guidelines and communication tools, in social cognitive theory and in motivational interviewing.
Along the interview, topics follow easy to read leaflets prepared to discuss the main benefits of contraception from the view of the immigrant communities, with guided discussions on family planning in the life course, the amount of time required to care children, the economic resources that newborn and children need, and an assessment of the knowledge on the contraceptive methods, and of their current use.
Contraceptive methods, abortion and emergency contraception are discussed.
Primary health care centre and sexual and reproductive health clinic access is reinforced.
|
|
无干预：Control
Control group without counseling
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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 |
|---|---|---|
|
Number of participants using consistently effective contraceptive methods (optimal use) assessed by questionnaire
大体时间：Three months after the baseline
|
Primary outcome is the consistent use of effective methods.
Effective methods include female sterilization, vasectomy, tube obstruction, IUD, implants, oral contraception, rings, patches, injections and female and male condoms
|
Three months after the baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants inconsistently using effective methods assessed by questionnaire
大体时间：Three months after the baseline
|
Inconsistent use of effective methods: Condoms used in some intercourse episodes and not others, condoms used improperly, taking birth control pills but missing too many doses for pregnancy prevention
|
Three months after the baseline
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Number of participants using less effective methods (withdrawal and periodic abstinence) assessed by questionnaire
大体时间：Three months after the baseline
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Use of less effective methods (withdrawal and periodic abstinence).
Practices such as douching are not considered a contraceptive method
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Three months after the baseline
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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：Elia Diez, MD、Agència de Salut Pública de Barcelona - Barcelna Public Health Agency
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10月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2016年6月28日
首先提交符合 QC 标准的
2016年6月28日
首次发布 (估计)
2016年6月30日
研究记录更新
最后更新发布 (估计)
2016年7月4日
上次提交的符合 QC 标准的更新
2016年6月30日
最后验证
2016年6月1日
更多信息
与本研究相关的术语
其他研究编号
- ediezSIRIAN
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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