Evaluation of a Counseling Intervention to Improve Contraceptive Use in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Number of participants using consistently effective contraceptive methods (optimal use) assessed by questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women living in the selected neighbourhoods aged 14-49 years
- •Men living in the selected neighbourhoods aged 14-39 years
排除标准
- •Having undergone an irreversible contraceptive method
- •Whishing or planning a pregnancy in the next year
结局指标
主要结局
Number of participants using consistently effective contraceptive methods (optimal use) assessed by questionnaire
时间窗: 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
次要结局
- Number of participants inconsistently using effective methods assessed by questionnaire(Three months after the baseline)
- Number of participants using less effective methods (withdrawal and periodic abstinence) assessed by questionnaire(Three months after the baseline)
研究者
Elia Diez David
Head of the Service of Programs and Preventive Interventions. Barcelona Public Health Agency
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau