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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Behavioral: Contraceptive counseling

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 Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08023
      • Agència de Salut Pública de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Contraceptive counseling	Behavioral: Contraceptive counseling; 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.
No Intervention: Control; Control group without counseling

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Elia Diez, MD, Agència de Salut Pública de Barcelona - Barcelna Public Health Agency

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: randomized control trial; contraception; inequalities
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: ediezSIRIAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED