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

Contraception Clinical Trial

— SIRIAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819388
• Other study ID #: ediezSIRIAN
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: June 30, 2016
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 49 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
Spain	Agència de Salut Pública de Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No