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Influence of Peer Mentoring on Adolescent Contraceptive Decision Making (ImPACCT)

5. juni 2014 opdateret af: Courtney Schreiber, University of Pennsylvania

The Influence of Peer Mentoring on Contraceptive Decision Making Among Adolescents

This is a prospective, randomized-controlled trial in which subjects will be randomized to receive either routine contraceptive counseling or peer mentoring plus routine contraceptive counseling.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Unintended adolescent pregnancy continues to be a significant public health problem in the United States. While the use of highly effective forms of birth control, such as the long-acting, reversible contraceptives (LARC) have been found to be more effective in decreasing pregnancy rates than non-LARC methods of birth control, knowledge and use of LARC has been shown to be low in this vulnerable population. We are interested in better understanding the influence peers may have on contraceptive decision making among adolescents. The purpose of this study is to evaluate the impact of a peer mentoring intervention on adolescent contraceptive decision making, specifically with regard to increasing long-acting, reversible contraceptive uptake. The main study intervention will consist of randomization to usual contraceptive counseling versus peer-mentoring plus usual contraceptive counseling. Pre- and post-intervention questionnaires will be used to better understand peer influence on contraceptive decision making, and to assess the peer mentor-teen intervention interaction.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania

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

13 år til 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • English speaking
  • Female
  • Age 13-21 years old at enrollment
  • Desiring contraception; either currently not taking any method of contraception, or not satisfied with current method, and not desiring pregnancy in the next 12 months
  • Willing and able to follow the study protocol

Exclusion Criteria:

  • Male gender
  • Younger than 13 years old, older than 21 years old
  • Pregnant or desiring pregnancy within the coming year
  • Issues or concerns in the judgement of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Routine Counseling
Subjects randomized to receive routine counseling before selecting a method of contraception
Eksperimentel: Peer Mentor counseling
Subjects randomized to receive peer counseling before selecting a method of contraception
Peer mentoring will entail the peer mentor describing her positive experience with her LARC method. The participant will then have a chance to ask any experience related questions to the mentor. Any clinical inquiries or questions the mentor does not feel comfortable answering, she will defer to the contraceptive counselor/ physician who will be subsequently providing the routine counseling. The entire peer mentor encounter should not last more than 10 minutes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of study participants who chose long-acting reversible contraception (LARC) after all contraceptive counseling was done.
Tidsramme: at enrollment/baseline visit
This data was obtained by the number of participants who chose to have an IUD or Implant inserted after counseling at their clinic visit.
at enrollment/baseline visit

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants who maintained LARC uptake
Tidsramme: 4 months from enrollment/baseline visit
This data is being obtained through a brief follow-up questionnaire conducted over the phone.
4 months from enrollment/baseline visit
Number of participants who maintained a positive opinion of LARC method as their primary choice for birth control
Tidsramme: 4 months after enrollment/baseline visit.
This data is being obtained through a brief follow-up questionnaire conducted over the phone.
4 months after enrollment/baseline visit.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Courtney A Schreiber, MD, University of Pennsylvania

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. februar 2013

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

19. marts 2013

Først indsendt, der opfyldte QC-kriterier

3. juni 2014

Først opslået (Skøn)

5. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 816769

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Peer Counseling

Kliniske forsøg med Peer Mentor Counseling

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