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Improving Contraceptive Counseling in the United States (ICC)

31 oktober 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

1418

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • New York, New York, Förenta staterna, 10001
        • New York University, Silver School of Social Work

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 30 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria:

  • Not seeking contraception from clinic on day of recruitment

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention
The intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling.
Beteende: Evidence informed birth control counseling
Counselors underwent training on the use of 10 best practices for contraceptive counseling.
Andra namn:
  • Improving contraceptive counseling in the United States
Inget ingripande: No intervention
The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: one year from initial clinic visit
one year from initial clinic visit

Sekundära resultatmått

Resultatmått
Tidsram
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).
Tidsram: six months to one year from initial clinic visit
six months to one year from initial clinic visit

Andra resultatmått

Resultatmått
Tidsram
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: six months to one year from initial clinic visit
six months to one year from initial clinic visit

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

New York University

Samarbetspartners

Planned Parenthood Federation of America

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2012

Primärt slutförande (Faktisk)

1 oktober 2014

Avslutad studie (Faktisk)

1 oktober 2015

Studieregistreringsdatum

Först inskickad

2 juni 2016

Först inskickad som uppfyllde QC-kriterierna

11 juni 2016

Första postat (Uppskatta)

15 juni 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 november 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 oktober 2022

Senast verifierad

1 juni 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • FPRPA006057
  • 12-9103 (Annan identifierare: NYU Committee on Activities Involving Human Subjects)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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