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

5. juli 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center

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

9 år til 17 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: single
single arm- behavioral educational intervention of a brief negotiated mobile application
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants who received the first dose and completed the vaccine series as measured electronic medical record review
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient knowledge and provider-patient communication
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cervical cancer screening rate
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

Boston Medical Center

Efterforskere

  • Ledende efterforsker: Natalie Joseph, MD MPH, Boston Medical Center

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 (Faktiske)

8. maj 2017

Primær færdiggørelse (Faktiske)

21. maj 2018

Studieafslutning (Faktiske)

8. juni 2018

Datoer for studieregistrering

Først indsendt

13. januar 2017

Først indsendt, der opfyldte QC-kriterier

25. januar 2017

Først opslået (Skøn)

27. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-34457

Plan for individuelle deltagerdata (IPD)

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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