NCT00119509

Brief Summary

The study compares the psychosocial outcomes of different management strategies for women with minor atypia (including 'HPV effect') detected on Pap smears: conventional management (a repeat Pap smear at 6 months) versus Human papillomavirus (HPV) DNA testing, a new method proposed for the management of minor atypia and the informed choice of either management supported by a decision aid. The study examines women's informed preferences for each of these options and compares the psychosocial outcomes in women who are or are not given the choice of management. HPV DNA testing offers considerable changes to the management of women with minor atypia and there is evidence from the USA which suggests that the use of HPV DNA testing as a triage strategy is effective for women within this group (Solomon et al 2001). The introduction of HPV DNA testing may bring both benefits and harms to women. These harms and benefits are not well understood. Examination of the psychosocial outcomes of HPV DNA testing compared to conventional management and women's preferences for each is needed to guide decisions concerning HPV DNA testing in cervical screening in Australia and also internationally.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2004

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

July 11, 2005

Last Update Submit

April 24, 2007

Conditions

Cervix Neoplasms

Keywords

Cervix NeoplasmsVaginal smearsPapillomavirus - Human

Outcome Measures

Primary Outcomes (2)

  • Psychosocial wellbeing assessed using psychometric scales including (a) global measures of psychological health (STAI, SF36)and (b) measures specific to cervical screening.

  • Quality of Life (Utility) Assessment two stage standard gamble (SG) technique produces a utility score between 0 and 1.

Secondary Outcomes (3)

  • Clinical outcomes: results of follow-up Pap smear and Colposcopy and HPV testing

  • Management preference: women's preference for HPV or repeat Pap testing measured by a Decision Aid.

  • Decision Aid evaluation: Measure the impact of the DA of knowledge, decisional conflict, and satisfaction with decision making

Interventions

HPV DNA testingPROCEDURE
Conventional management (repeat Pap smear at 6 months)PROCEDURE
Decision aid with choice of managementPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with ONLY the following results on a routine Pap smear:
  • Low grade epithelial abnormality;
  • Minor changes in squamous cell;
  • Minor changes in squamous cells with appearances consistent with Papillomavirus
  • Women aged between 18-70 years

You may not qualify if:

  • Women who are pregnant or planning to become pregnant in the next 12 months
  • Women with previous Pap smear abnormality for 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

North Coast Community Health Centre

Port Macquarie, New South Wales, 2444, Australia

Location

Family Planning Association

Sydney, New South Wales, 2000, Australia

Location

Taree Community Health Centre

Taree, New South Wales, 2430, Australia

Location

Illawarra Women's Health Centre

Warilla, New South Wales, 2528, Australia

Location

Family Planning Queensland

Brisbane, Queensland, 4006, Australia

Location

Shine SA

Adelaide, South Australia, 5068, Australia

Location

Family Planning Western Australia

Perth, Western Australia, 6865, Australia

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Kirsten McCaffery, PhD

    University of Sydney

    STUDY CHAIR

  • Les Irwig, PhD

    University of Sydney

    STUDY DIRECTOR

  • Glenn Salkeld, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

  • Alexandra Barratt, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

  • Kirsten Howard, Masters

    University of Sydney

    PRINCIPAL INVESTIGATOR

  • Edith Weisberg, Medicine

    Family Planning Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2005

First Posted

July 13, 2005

Study Start

January 1, 2004

Study Completion

April 1, 2008

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

AU(7)