Evaluation of a Contraceptive Counseling Intervention in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial (SIRIAN)
30. juni 2016 opdateret af: Elia Diez David, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
500
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 08023
- Agència de Salut Pública de Barcelona
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 49 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
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.
|
|
Ingen indgriben: Control
Control group without counseling
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants using consistently effective contraceptive methods (optimal use) assessed by questionnaire
Tidsramme: 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
|
Three months after the baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants inconsistently using effective methods assessed by questionnaire
Tidsramme: Three months after the baseline
|
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
Tidsramme: Three months after the baseline
|
Use of less effective methods (withdrawal and periodic abstinence).
Practices such as douching are not considered a contraceptive method
|
Three months after the baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Elia Diez, MD, Agència de Salut Pública de Barcelona - Barcelna Public Health Agency
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2011
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
28. juni 2016
Først indsendt, der opfyldte QC-kriterier
28. juni 2016
Først opslået (Skøn)
30. juni 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juni 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ediezSIRIAN
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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