The IMAP Study Improving Management of Mildly Abnormal Pap Smears
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
University of Sydney
300 participants
Jan 27, 2004
Interventional
Conditions
Summary
The study compares the psychosocial outcomes of different management strategies for women with minor atypia (incl '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 not given the choice of management.
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria1
- Women who are pregnant or planning to become pregnant in the next 12 months. Women with previous Pap smear abnormality for 2 years.
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Interventions
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) a 6 month repeat Pap smear (conventional management), or (c) Decision Aid (DA) with choice of either 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.
Locations(1)
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ACTRN12605000111673