Cervix NeoplasmsPhase 3NCT00119509
The IMAP Study Improving Management of Mildly Abnormal Pap Smears
A Phase 3 study testing HPV DNA testing, Conventional management (repeat Pap smear at 6 months) and Decision aid with choice of management in people with Cervix Neoplasms, run by University of Sydney at 7 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervix Neoplasms
- What is being tested?
- HPV DNA testing, Conventional management (repeat Pap smear at 6 months) and Decision aid with choice of management
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 7 sitesAustralia
- Study dates
- Jan 2004to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who are pregnant or planning to become pregnant in the next 12 months
- Women with previous Pap smear abnormality for 2 years.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Shine SA
Adelaide, South Australia, 5068
Family Planning Queensland
Brisbane, Queensland, 4006
Family Planning Western Australia
Perth, Western Australia, 6865
North Coast Community Health Centre
Port Macquarie, New South Wales, 2444
Family Planning Association
Sydney, New South Wales, 2000
Taree Community Health Centre
Taree, New South Wales, 2430
Illawarra Women's Health Centre
Warilla, New South Wales, 2528
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Cervix Neoplasms
- Being tested
- HPV DNA testing, Conventional management (repeat Pap smear at 6 months), Decision aid with choice of management
- Keywords
- Cervix Neoplasms, Vaginal smears, Papillomavirus - Human
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV DNA testingProcedure or surgery
Conventional management (repeat Pap smear at 6 months)Procedure or surgery
Decision aid with choice of managementProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial wellbeing assessed using psychometric scales including (a) global measures of psychological health (STAI, SF36)and (b) measures specific to cervical screening.
Quality of Life (Utility) Assessment two stage standard gamble (SG) technique produces a utility score between 0 and 1.
Secondary outcomes (3)
Clinical outcomes: results of follow-up Pap smear and Colposcopy and HPV testing
Management preference: women's preference for HPV or repeat Pap testing measured by a Decision Aid.
Decision Aid evaluation: Measure the impact of the DA of knowledge, decisional conflict, and satisfaction with decision making
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startJan 2004
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Family Planning Association New South Wales
- Investigators
- Kirsten McCaffery, PhD, Study chair, University of SydneyLes Irwig, PhD, Study director, University of SydneyGlenn Salkeld, PhD, Principal investigator, University of SydneyAlexandra Barratt, PhD, Principal investigator, University of SydneyKirsten Howard, Masters, Principal investigator, University of SydneyEdith Weisberg, Medicine, Principal investigator, Family Planning Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119509
- Sponsor's protocol ID
- 211205_IMAP
- Status last verified
- Apr 2007
- First submitted
- 11 Jul 2005
- Last updated
- 25 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00119509
- Acronym / sponsor ID
- 211205_IMAP
- Conditions
- Cervix Neoplasms
- Keywords
- Cervix Neoplasms, Vaginal smears, Papillomavirus - Human
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Family Planning Association New South Wales
- Study start
- Jan 2004
- Study completion
- Apr 2008 (estimated)
- First posted
- 13 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with ONLY the following results on a routine Pap smear:
- Women aged between 18-70 years
Key exclusion criteria (2 listed)
- Women who are pregnant or planning to become pregnant in the next 12 months
- Women with previous Pap smear abnormality for 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV DNA testing | Procedure or surgery | – |
| Conventional management (repeat Pap smear at 6 months) | Procedure or surgery | – |
| Decision aid with choice of management | Procedure or surgery | – |
Primary outcome
Psychosocial wellbeing assessed using psychometric scales including (a) global measures of psychological health (STAI, SF36)and (b) measures specific to cervical screening.
Quality of Life (Utility) Assessment two stage standard gamble (SG) technique produces a utility score between 0 and 1.
3 secondary outcomes
Clinical outcomes: results of follow-up Pap smear and Colposcopy and HPV testing
Management preference: women's preference for HPV or repeat Pap testing measured by a Decision Aid.
Decision Aid evaluation: Measure the impact of the DA of knowledge, decisional conflict, and satisfaction with decision making
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten McCaffery, PhD study chair
University of Sydney
Les Irwig, PhD study director
University of Sydney
Glenn Salkeld, PhD principal investigator
University of Sydney
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HPV DNA testing, Conventional management (repeat Pap smear at 6 months) and Decision aid with choice of management in people with Cervix Neoplasms, run by University of Sydney at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial wellbeing assessed using psychometric scales including (a) global measures of psychological health (STAI, SF36)and (b) measures specific to cervical screening.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2007.