The IMAP Study Improving Management of Mildly Abnormal Pap Smears

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Sydney.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Family Planning Association New South Wales
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00119509
First received: July 11, 2005
Last updated: April 24, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Cervix Neoplasms
Procedure: HPV DNA testing
Procedure: Conventional management (repeat Pap smear at 6 months)
Procedure: Decision aid with choice of management
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 300
Study Start Date: January 2004
Estimated Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119509

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

No publications provided

ClinicalTrials.gov Identifier: NCT00119509     History of Changes
Other Study ID Numbers: 211205_IMAP
Study First Received: July 11, 2005
Last Updated: April 24, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:
Cervix Neoplasms
Vaginal smears
Papillomavirus - Human

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 27, 2014