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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00119509




Registration number
NCT00119509
Ethics application status
Date submitted
11/07/2005
Date registered
13/07/2005
Date last updated
25/04/2007

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
Secondary ID [1] 0 0
211205_IMAP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervix Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - HPV DNA testing
Treatment: Surgery - Conventional management (repeat Pap smear at 6 months)
Treatment: Surgery - Decision aid with choice of management

Treatment: Surgery: HPV DNA testing


Treatment: Surgery: Conventional management (repeat Pap smear at 6 months)


Treatment: Surgery: Decision aid with choice of management


Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Psychosocial wellbeing assessed using psychometric scales including (a) global measures of psychological health (STAI, SF36)and (b) measures specific to cervical screening.
Timepoint [1] 0 0
Primary outcome [2] 0 0
Quality of Life (Utility) Assessment two stage standard gamble (SG) technique produces a utility score between 0 and 1.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Clinical outcomes: results of follow-up Pap smear and Colposcopy and HPV testing
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Management preference: women’s preference for HPV or repeat Pap testing measured by a Decision Aid.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Decision Aid evaluation: Measure the impact of the DA of knowledge, decisional conflict, and satisfaction with decision making
Timepoint [3] 0 0

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

- Women aged between 18-70 years
Minimum age
18 Years
Maximum age
70 Years
Gender
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
North Coast Community Health Centre - Port Macquarie
Recruitment hospital [2] 0 0
Family Planning Association - Sydney
Recruitment hospital [3] 0 0
Taree Community Health Centre - Taree
Recruitment hospital [4] 0 0
Illawarra Women's Health Centre - Warilla
Recruitment hospital [5] 0 0
Family Planning Queensland - Brisbane
Recruitment hospital [6] 0 0
Shine SA - Adelaide
Recruitment hospital [7] 0 0
Family Planning Western Australia - Perth
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2430 - Taree
Recruitment postcode(s) [4] 0 0
2528 - Warilla
Recruitment postcode(s) [5] 0 0
4006 - Brisbane
Recruitment postcode(s) [6] 0 0
5068 - Adelaide
Recruitment postcode(s) [7] 0 0
6865 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Family Planning Association New South Wales
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00119509
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kirsten McCaffery, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00119509