Evaluation of a Contraceptive Counseling Intervention in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Counseling Intervention to Improve Contraceptive Use in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial.

Conditions
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Contraception

Intervention / Treatment
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* Behavioral: Contraceptive counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Contraceptive counseling | Behavioral: Contraceptive counseling<br>* 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.<br>|
| No Intervention: Control<br>Control group without counseling | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants using consistently effective contraceptive methods (optimal use) assessed by questionnaire | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants inconsistently using effective methods assessed by questionnaire | 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 | 
| Number of participants using less effective methods (withdrawal and periodic abstinence) assessed by questionnaire | Use of less effective methods (withdrawal and periodic abstinence). Practices such as douching are not considered a contraceptive method | Three months after the baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized control trial; contraception; inequalities