Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000111673
Ethics application status
Approved
Date submitted
27/07/2005
Date registered
9/08/2005
Date last updated
9/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The IMAP Study Improving Management of Mildly Abnormal Pap Smears
Scientific 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
Universal Trial Number (UTN)
Trial acronym
IMAP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical neoplasms 199 0
Condition category
Condition code
Cancer 221 221 0 0
Cervical (Cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 71 0
None
Comparator / control treatment
Women who are allocated to the HPV DNA arm and the repeat Pap will receive standard information about their management strategy.
Control group
Active

Outcomes
Primary outcome [1] 269 0
Psycho-social.

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 arms of the decision aid; (3) Psycho-social impact questionnaire - brief questionnaire (taking approximately 10 minutes to complete) sent at multiple time points to assess the psycho-social impact over time
Timepoint [1] 269 0
At baseline, 2 weeks, 3, 6, and 12 months.
Primary outcome [2] 270 0
Quality Of Life.

Participants will be invited to take part in an interview (HPV testing or repeat Pap smear) to assess quality of life using standardised validated QOL measures.
Timepoint [2] 270 0
At 1 month and 12 months post testing.
Secondary outcome [1] 595 0
Management and clinical outcomes
Timepoint [1] 595 0
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.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation was central and staff who randomised did not have anything to do with the treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated using random number generator in STATA, blocking used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 279 0
Government body
Name [1] 279 0
NHMRC
Country [1] 279 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 214 0
Government body
Name [1] 214 0
Family Planning Association
Address [1] 214 0
Country [1] 214 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1127 0
FPA Health
Ethics committee address [1] 1127 0
Sydney NSW
Ethics committee country [1] 1127 0
Australia
Date submitted for ethics approval [1] 1127 0
Approval date [1] 1127 0
Ethics approval number [1] 1127 0
Ethics committee name [2] 1128 0
SHine SA
Ethics committee address [2] 1128 0
Adelaide South Australia
Ethics committee country [2] 1128 0
Australia
Date submitted for ethics approval [2] 1128 0
Approval date [2] 1128 0
Ethics approval number [2] 1128 0
Ethics committee name [3] 1129 0
Family Planning Queensland
Ethics committee address [3] 1129 0
Brisbane Queensland
Ethics committee country [3] 1129 0
Australia
Date submitted for ethics approval [3] 1129 0
Approval date [3] 1129 0
Ethics approval number [3] 1129 0
Ethics committee name [4] 1130 0
Illawarra Women's Health Centre
Ethics committee address [4] 1130 0
Warilla NSW
Ethics committee country [4] 1130 0
Australia
Date submitted for ethics approval [4] 1130 0
Approval date [4] 1130 0
Ethics approval number [4] 1130 0
Ethics committee name [5] 1131 0
Family Planning Western Australia
Ethics committee address [5] 1131 0
Perth WA
Ethics committee country [5] 1131 0
Australia
Date submitted for ethics approval [5] 1131 0
Approval date [5] 1131 0
Ethics approval number [5] 1131 0
Ethics committee name [6] 1132 0
Taree Community Health Centre
Ethics committee address [6] 1132 0
Taree NSW
Ethics committee country [6] 1132 0
Australia
Date submitted for ethics approval [6] 1132 0
Approval date [6] 1132 0
Ethics approval number [6] 1132 0
Ethics committee name [7] 1133 0
North Coast Community Health Centre
Ethics committee address [7] 1133 0
Port Macquarie NSW
Ethics committee country [7] 1133 0
Australia
Date submitted for ethics approval [7] 1133 0
Approval date [7] 1133 0
Ethics approval number [7] 1133 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36372 0
Address 36372 0
Country 36372 0
Phone 36372 0
Fax 36372 0
Email 36372 0
Contact person for public queries
Name 9260 0
Dr Kirsten McCaffery
Address 9260 0
Screening and Test Evaluation Program
School of Public Health
University of Sydney
Edward Ford Building
Sydney NSW 2006
Country 9260 0
Australia
Phone 9260 0
+61 2 93517220
Fax 9260 0
+61 2 93515049
Email 9260 0
[email protected]
Contact person for scientific queries
Name 188 0
Dr Kirsten McCaffery
Address 188 0
Screening and Test Evaluation Program
School of Public Health
University of Sydney
Edward Ford Building
Sydney NSW 2006
Country 188 0
Australia
Phone 188 0
+61 2 93517220
Fax 188 0
+61 2 93515049
Email 188 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.