The IMAP Study Improving Management of Mildly Abnormal Pap Smears

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.

Conditions

• Cervix Neoplasms

Interventions

PROCEDURE

HPV DNA testing

PROCEDURE

Conventional management (repeat Pap smear at 6 months)

PROCEDURE

Decision aid with choice of management

Sponsors & Collaborators

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Family Planning Association New South Wales

  collaborator OTHER_GOV

• University of Sydney

  lead OTHER

Principal Investigators

• Kirsten McCaffery, PhD · University of Sydney

• Les Irwig, PhD · University of Sydney

• Glenn Salkeld, PhD · University of Sydney

• Alexandra Barratt, PhD · University of Sydney

• Kirsten Howard, Masters · University of Sydney

• Edith Weisberg, Medicine · Family Planning Association

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Completion

2008-04-30

Countries

• Australia

Study Locations