- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02157285
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
Betingelser
Intervention / Behandling
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.
Sponsor
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
-
Texas Christian UniversityAfsluttetMapping Enhanced Counseling (MEC) | Active Linkage (AL)Forenede Stater
-
Zhejiang Chinese Medical UniversityTilmelding efter invitation
-
Assistance Publique - Hôpitaux de ParisUniversity of California, Los Angeles; University of Oxford; University of...Afsluttet
-
Oregon Health and Science UniversityEmory University; Ohio State University; University of Kentucky; University...AfsluttetStofbrug | Peer indflydelseForenede Stater
-
University of WashingtonAfsluttet
-
University of SouthamptonSolent NHS TrustTrukket tilbagePeer gruppeDet Forenede Kongerige
-
The University of Hong KongAfsluttet
-
National Taiwan University HospitalTilmelding efter invitationPeer Review, SundhedsplejeTaiwan
-
MetroHealth Medical CenterAfsluttetPeer Review, ForskningForenede Stater
-
Misr International UniversityAfsluttetAnmeldelse, Research PeerEgypten
Kliniske forsøg med Peer Mentor Counseling
-
Johns Hopkins Bloomberg School of Public HealthAfsluttetHepatitis C | HIV | RisikoreduktionsadfærdForenede Stater
-
Sunnybrook Health Sciences CentreCanadian Arthritis NetworkAfsluttetKronisk sygdom | Tidlig inflammatorisk arthritisCanada
-
Nova Scotia Health AuthorityRekruttering
-
University College CopenhagenNordsjællands HospitalAfsluttetIskæmisk hjertesygdomDanmark
-
Johns Hopkins Bloomberg School of Public HealthNational Institute on Drug Abuse (NIDA); Johns Hopkins UniversityAfsluttetHIV-infektionerDen Russiske Føderation
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityAfsluttetType 2 diabetes mellitus | Kardiometaboliske tilstande | Adfærdsmæssige sundhedsproblemerForenede Stater
-
Johns Hopkins UniversityHealthways, Inc.Trukket tilbageStofmisbrugForenede Stater
-
Indiana UniversityNational Institutes of Health (NIH); National Center for Advancing Translational... og andre samarbejdspartnereTilmelding efter invitationStigma, social | HIV præ-eksponeringsprofylakseKenya
-
Weill Medical College of Cornell UniversityAfsluttetKoronararteriesygdomForenede Stater
-
The Miriam HospitalAfsluttet