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

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Behavioral: Contraceptive counseling

• Registration Number: NCT02819388
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-06
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-30
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Contraceptive counseling	Contraceptive counseling

Primary Outcome Measures

Name	Time	Method
Number of participants using consistently effective contraceptive methods (optimal use) assessed by questionnaire	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Agència de Salut Pública de Barcelona; 🇪🇸 Barcelona, Catalonia, Spain