Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Integrating Primary & Secondary Interventions for Cervical Cancer Prevention in Primary Care Settings

5. Juli 2018 aktualisiert von: Natalie Pierre-Joseph, Boston Medical Center

A Single-arm Proof of Concept, Open Trial Clinical Study Investigating the Feasibility and Efficacy of Integrating Behavioral and Mobile Health Educational Interventions for Primary and Secondary Prevention in the Primary Care Setting

The purpose of this study is to determine whether a mobile health educational intervention for Human PapillomaVirus (HPV) Vaccination promotion and cervical cancer screening in Primary Care settings is a feasible behavioral intervention to integrate as a primary and secondary cervical cancer prevention approach.Study Design: The investigators will conduct an open feasibility proof-of-concept trial using a single experimental group with all subjects receiving the behavioral intervention being studied.

Outcome measures. The primary outcome of interest is receipt of the first dose and completion of the three-dose series of HPV vaccine within 6 month of intervention, this will be evaluated by Electronic medical review review.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Background: Nearly 80 million people in the US are infected with HPV and 14 million new cases are diagnosed annually. There is an increasing HPV prevalence among women through the young adult years. Although the body clears many HPV infections persistent infections can progress to cancer and other HPV-related diseases. Cervical cancer is the most common cancer caused by HPV.

Many of the HPV-associated cancers are preventable with a series of safe and effective HPV vaccines. To date, no state has attained the 80% target vaccination rate for HPV. Despite the proven benefits and safety of HPV vaccine, usage remains suboptimal (only 38% had completed the three-dose series) and lower than other recommended adolescent vaccines.

Objective/Hypothesis: Our short term objective is to increase HPV vaccine initiation and completion rates among all age-eligible adolescent girls for whom vaccine is not contraindicated; and explore and examine acceptability of providing HPV vaccination to female youth during her adult female guardian's (AFG) cervical cancer screening appointment.

The investigators hypothesize that a combined intervention which includes (1) a motivational web-based education aimed at AFGs and youth females in their Primary Care site; and (2) text message reminders and an informational web-link on HPV vaccine and cervical cancer screening will increase HPV vaccination rates among youth females and will increase cervical cancer screening rates among their respective AFGs.

The investigators propose the following Aim:

Specific Aim: Conduct a single-arm proof of concept, open trial clinical study investigating the feasibility and efficacy of integrating primary and secondary prevention model for HPV and cervical cancer: a mobile educational and automated electronic interactive messaging intervention that will remind AFG and youth females of scheduled and missed second and third HPV vaccination appointments, and deliver brief text and video educational messaging on HPV, HPV vaccine, and cervical cancer screening.

Study Design: The investigators will conduct an open feasibility proof-of-concept trial using a single experimental group with all subjects receiving the behavioral intervention being studied.

Outcome measures. The primary outcome of interest is receipt of the first dose and completion of the three-dose series of HPV vaccine within 6 month of intervention, this will be evaluated by Electronic medical review review.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02118
        • Boston Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

9 Jahre bis 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • AFG ages 30 years and older who receive primary care at the study sites.
  • AFG consent to have cervical cancer screening status checked in Electronic Medical Record.
  • AFG has a daughter between the ages of 11 to 17 who receive primary care at either
  • Family Medicine or Pediatric and Adolescent primary care clinic at Boston Medical Center.
  • AFG consent to have daughter's HPV vaccination status checked in Electronic Medical Record.
  • AFG's daughter has neither initiated the HPV vaccine nor completed the three vaccine series
  • AFG and daughter have the ability to read and write in English.
  • AFG and daughter each have a cell phone with text messages capabilities.

Exclusion Criteria:

  • The investigators will exclude based on the following criteria:
  • AFG being seen for a sick visit.
  • AFG has an adolescent daughter who is pregnant or is a mother.
  • AFG has a daughter who has completed the three dose HPV vaccine series.
  • AFG, in the opinion of the clinical staff, is cognitively impaired and unable to give informed consent and may not participate.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: single
single arm- behavioral educational intervention of a brief negotiated mobile application
Verhalten: brief negotiated mobile application
The intervention will supplement the standard of care with the following steps: (1) mobile- based brief negotiated Intervention ( BNI); (2) a customized companion communication vaccine report to be given before AFG sees provider; and (3) automated interactive Electronic Recall/Reminder Messages (Text messaging), including text messaging and access to a website which includes information about HPV, HPV Vaccine, and cervical cancer screening guideline.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants who received the first dose and completed the vaccine series as measured electronic medical record review
Zeitfenster: up to 6 months
The primary outcome of interest is receipt of the first dose and completion of the three or two-dose series of HPV vaccine by participants within 6 month of intervention, this will be evaluated by Electronic Measure Review. Unit of measure: Number of participants who received the first doses and who competed the total number of does based - recorded as percentage who receive the first dose, and completed the two or 3 doses.
up to 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient knowledge and provider-patient communication
Zeitfenster: over 6 months
The secondary outcomes are: (a) Change in knowledge of HPV, HPV vaccination, and cervical cancer screening as evaluated by pre/post intervention survey: unit of Measure: based on a 1-10 point scale, with 10 being the highest score;
over 6 months
provider communication about HPV vaccine
Zeitfenster: through study completion, an average of 1 year
greater provider communication about HPV vaccine : Unit of measure- the number of participants who responded yes to provider communication about HPV vaccine
through study completion, an average of 1 year

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cervical cancer screening rate
Zeitfenster: through study completion, an average of 1 year
Cervical cancer screening rate as evaluated by Electronic Medical Review review: Unit of Measure: Number of participants who has cervical cancer screening within the time guideline ( as measured and reported as percentage who screened within the pap smear guideline
through study completion, an average of 1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boston Medical Center

Ermittler

  • Hauptermittler: Natalie Joseph, MD MPH, Boston Medical Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

8. Mai 2017

Primärer Abschluss (Tatsächlich)

21. Mai 2018

Studienabschluss (Tatsächlich)

8. Juni 2018

Studienanmeldedaten

Zuerst eingereicht

13. Januar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Januar 2017

Zuerst gepostet (Schätzen)

27. Januar 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juli 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juli 2018

Zuletzt verifiziert

1. Juli 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H-34457

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur HPV-bedingtes Karzinom

Klinische Studien zur brief negotiated mobile application

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Kenya

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren