The IMAP Study Improving Management of Mildly Abnormal Pap Smears

April 24, 2007 updated by: University of Sydney

HPV DNA Testing Versus Conventional Management for Women With Minor Atypia on Pap Smear: Psychosocial and Quality of Life Outcomes and Development of a Decision Analytic Model

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Women diagnosed with minor atypia following a routine Pap smear will be randomised into one of the three management arms of the study (a) HPV DNA test, (b) Decision Aid (DA) with choice of management, or (c) a 6 month repeat Pap smear (conventional management). Women who are allocated to the HPV DNA arm and the repeat Pap will receive standard information about their management strategy. Women allocated to the decision aid arm will receive information about HPV DNA testing and 6 month repeat Pap in a decision aid format as an adjunct to usual clinical care and asked to indicate their preference for management. Women in this arm will receive the management strategy of their choice (HPV DNA or repeat Pap). The impact of the Decision Aid will be assessed and psychosocial impact of each management strategy will be followed up over the short, medium and long term.

Management and Clinical outcomes: Data will be collected on the taking and timing of Pap smears, HPV testing and colposcopy as well as findings for each of these tests and any subsequent treatment.

Psychosocial outcomes: Measures will be administered by postal questionnaire at multiple time points across the study. There will be 3 questionnaires: (1) Baseline questionnaire - for all participants recruited into the study; (2) Decision-making evaluation - to assess decision-making in all groups and the impact of the decision aid; (3) Psychosocial impact questionnaire - brief questionnaire (taking approximately 10 minutes to complete) sent at multiple time points to assess the psychosocial impact over time (2 weeks, 3, 6 and 12 months).

Quality of life assessment: Participants will be invited to take part in an interview at 1 month and 12 months post testing (HPV testing or repeat Pap smear) to assess quality of life using standardised validated QOL measures. Interviews will be carried out by an experienced female researcher. Study participants will be given the option to participate in the interview and will be under no obligation to take part if they do not wish to.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Port Macquarie, New South Wales, Australia, 2444
        • North Coast Community Health Centre
      • Sydney, New South Wales, Australia, 2000
        • Family Planning Association
      • Taree, New South Wales, Australia, 2430
        • Taree Community Health Centre
      • Warilla, New South Wales, Australia, 2528
        • Illawarra Women's Health Centre
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • Family Planning Queensland
    • South Australia
      • Adelaide, South Australia, Australia, 5068
        • Shine SA
    • Western Australia
      • Perth, Western Australia, Australia, 6865
        • Family Planning Western Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Collaborators

National Health and Medical Research Council, Australia
Family Planning Association New South Wales

Investigators

  • Study Chair: Kirsten McCaffery, PhD, University of Sydney
  • Study Director: Les Irwig, PhD, University of Sydney
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Anticipated)

April 1, 2008

Study Registration Dates

First Submitted

July 11, 2005

First Submitted That Met QC Criteria

July 11, 2005

First Posted (Estimate)

July 13, 2005

Study Record Updates

Last Update Posted (Estimate)

April 25, 2007

Last Update Submitted That Met QC Criteria

April 24, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211205_IMAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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