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

F

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

Status

Completed

Conditions

Contraception

Treatments

Behavioral: Contraceptive counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02819388
ediezSIRIAN

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 patients

Sex

All

Ages

14 to 49 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

Intervention
Experimental group
Description:
Contraceptive counseling
Treatment:
Behavioral: Contraceptive counseling
Control
No Intervention group
Description:
Control group without counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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