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Clinical Trials/NCT02819388
NCT02819388
Completed
Not Applicable

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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country500 target enrollmentOctober 2011
ConditionsContraception

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contraception
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
500
Locations
1
Primary Endpoint
Number of participants using consistently effective contraceptive methods (optimal use) assessed by questionnaire
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
December 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible Party
Principal Investigator
Principal Investigator

Elia Diez David

Head of the Service of Programs and Preventive Interventions. Barcelona Public Health Agency

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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 Sites (1)

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