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Improving Contraceptive Counseling in the United States (ICC)

31. oktober 2022 oppdatert av: New York University
This project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. The project develops and refines the CCP using focus groups and in-depth interviews with (a) key administrators in the national office of Planned Parenthood (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and (d) clients of the health centers. The CCP uses scientifically grounded principles for guiding effective decision making and provider-client communication. Ten Title X clinics are randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study participation in each clinic, yielding about 1,400 participants (half control and half CCP). Immediately following their counseling session, women complete a computer-administered interview that serves as a fidelity check and permits evaluation of the effects of the CCP on variables associated with counseling satisfaction. All women are re-interviewed by phone 6 months later and 12 months later. The effect of the CCP on method-choice effectiveness, method switching, gaps in protection, and use accuracy are evaluated.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1418

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10001
        • New York University, Silver School of Social Work

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 30 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria:

  • Not seeking contraception from clinic on day of recruitment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
The intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling.
Atferdsmessig: Evidence informed birth control counseling
Counselors underwent training on the use of 10 best practices for contraceptive counseling.
Andre navn:
  • Improving contraceptive counseling in the United States
Ingen inngripen: No intervention
The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.
Tidsramme: immediately after counseling session
immediately after counseling session
Patient satisfaction with counseling session as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
Tidsramme: immediately after counseling session
immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
Tidsramme: immediately after counseling session
immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 6 months.
Tidsramme: 6 months from initial clinic visit
6 months from initial clinic visit
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 12 months.
Tidsramme: one year from initial clinic visit
one year from initial clinic visit

Sekundære resultatmål

Resultatmål
Tidsramme
Type of contraceptive method currently using (including none and dual use) as assessed by a questionnaire designed for this study (e.g., what method of birth control are you currently using).
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit

Andre resultatmål

Resultatmål
Tidsramme
Method switching for pill users as assessed by a questionnaire designed for this study asking current method used at posttest to determine if it is no longer the pill using questions designed for this study
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit
Gaps in pregnancy protection (number of weeks not using any birth control during contraceptive method switches as assessed by a questionnaire designed for this study using retrospective recall
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit
Counselor behavior (topics covered during counseling) as assessed by a questionnaire designed for this study asking if counselor did or did not address key topics about method use
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit
Pill users retrospective report of the number of missed pills using a questionnaire designed for this study
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

New York University

Samarbeidspartnere

Planned Parenthood Federation of America

Etterforskere

  • Hovedetterforsker: James J Jaccard, PhD, New York University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

1. oktober 2014

Studiet fullført (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først innsendt

2. juni 2016

Først innsendt som oppfylte QC-kriteriene

11. juni 2016

Først lagt ut (Anslag)

15. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. november 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. oktober 2022

Sist bekreftet

1. juni 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FPRPA006057
  • 12-9103 (Annen identifikator: NYU Committee on Activities Involving Human Subjects)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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