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

NCT02819388 | Completed DMC

• 1 other identifier: ediezSIRIAN
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

randomized control trial; contraception; inequalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Contraceptive counseling

Behavioral: Contraceptive counseling

Control

NO INTERVENTION

Control group without counseling

Interventions

Contraceptive counseling BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 14 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women living in the selected neighbourhoods aged 14-49 years
• Men living in the selected neighbourhoods aged 14-39 years

You may not qualify if:

• Having undergone an irreversible contraceptive method
• Whishing or planning a pregnancy in the next year

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Agència de Salut Pública de Barcelona

Barcelona, Catalonia, 08023, Spain

Location

Study Officials

• Elia Diez, MD

  Agència de Salut Pública de Barcelona - Barcelna Public Health Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Service of Programs and Preventive Interventions. Barcelona Public Health Agency

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 4, 2016

Record last verified: 2016-06

Locations

ES (1)