RecruitingPhase 3ACTRN12605000111673

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

Sponsor

University of Sydney

Enrollment

300 participants

Start Date

Jan 27, 2004

Study Type

Interventional

Conditions

Cervical neoplasms

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

Sex: FemalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study, called the IMAP Study, looks at the best way to manage women who have minor abnormal changes found on a Pap smear (cervical screening test). Researchers compare the standard approach (repeating the Pap smear in 6 months) with a newer approach using HPV (Human Papillomavirus) DNA testing. It also looks at how women feel about their choices and which option they prefer. You may be eligible if: - You are a woman between 18 and 70 years old - You have had a Pap smear showing only a minor abnormality (low-grade changes or changes consistent with HPV) You may NOT be eligible if: - You are pregnant or planning to become pregnant in the next 12 months - You have had an abnormal Pap smear in the last 2 years Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Australia

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ACTRN12605000111673