The IMAP Study Improving Management of Mildly Abnormal Pap Smears
The IMAP Study Improving Management of Mildly Abnormal Pap Smears
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.
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.
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.