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Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention (APACHE-2)

11 september 2014 uppdaterad av: University Hospital, Tours

Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample

Scientific Context:

High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.

The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home.

Description of the project :

Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:

  • Intervention arm 1:

Women will receive a further invitation to make a cervical smear

  • Intervention arm 2:

Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV).

For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.

  • Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

5998

Fas

  • Tidig fas 1

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

30 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria :

  • Women from 30 to 65 years
  • Living in Indre-et-Loire (french territorial division 37)

Exclusion Criteria :

  • Women who attend organized cervical cancer screening or who answer to the invitation
  • Cervical smear made in the three last years
  • HPV linked cervical condition undergoing treatment
  • Hysterectomy (including cervix)

Studieplan

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

Hur är studien utformad?

Designdetaljer

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

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Group 1 : Further invitation by mail
Further invitation to attend for cervical cytology
Beteende: Attending for cervical cytology
A further invitation to attend for cervical cytology are going to be sent by mail to women
Experimentell: Group 2 : Kit for Self-collected vaginal sample
Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV)
Beteende: Kit for Self-collected vaginal sample
Kit for self-collected vaginal sample are going to be directly sent at women's home
Inget ingripande: Group 3: Control

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Comparison of women's attitude according to the arm: participation or not to a whole screening action
Tidsram: 9 months after the beginning of the study (sending of mails)

Comparison of attitudes among women not attending organized cervical cancer according to the type of intervention or the lack of intervention: participation or not to a whole screening action.

Are considered as whole screening action:

  • cervical smear
  • HPV DNA testing on self-collected vaginal sample negative (no infection by a high-risk HPV)
  • HPV DNA testing on self-collected vaginal sample positive (infection by a high-risk HPV) followed by a cervical smear
9 months after the beginning of the study (sending of mails)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Analysis in sub-groups
Tidsram: 9 months after the beginning of the study (sending of mails)

Analysis in sub-groups in order to compare the efficacy of interventions according to :

  • The age
  • Health insurance system
  • Distribution map (urban area, peri-urban area, rural area)
9 months after the beginning of the study (sending of mails)
Identification of the psychological determinants and mechanisms (checks and motivational factors)
Tidsram: 9 months after the beginning of the study (sending of mails)

Identify the psychological determinants and mechanisms (checks and motivational factors) that can affect enrollment to the screening procedure for self-collection vaginal sample or cervical smear.

Nine months after the beginning of the study, a questionnaire will be send to the 6000 women.
9 months after the beginning of the study (sending of mails)

Samarbetspartners och utredare

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

Sponsor

University Hospital, Tours

Utredare

  • Studierektor: Ken HAGUENOER, François Rabelais University, Public Health Laboratory, Tours, France

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 februari 2012

Primärt slutförande (Faktisk)

1 december 2012

Avslutad studie (Faktisk)

1 december 2012

Studieregistreringsdatum

Först inskickad

12 mars 2012

Först inskickad som uppfyllde QC-kriterierna

27 april 2012

Första postat (Uppskatta)

30 april 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

12 september 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2014

Senast verifierad

1 juli 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • INCA08-KH / APACHE-2

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