Clinical trial · Interventional
The IMAP Study Improving Management of Mildly Abnormal Pap Smears
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional management (repeat Pap smear at 6 months) | Procedure | — | UNRESOLVED |
| Decision aid with choice of management | Procedure | — | UNRESOLVED |
| HPV DNA testing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Psychosocial wellbeing assessed using psychometric scales including (a) global measures of psychological health (STAI, SF36)and (b) measures specific to cervical screening.
- measure
- Quality of Life (Utility) Assessment two stage standard gamble (SG) technique produces a utility score between 0 and 1.
Secondary outcomes (3)
- measure
- Clinical outcomes: results of follow-up Pap smear and Colposcopy and HPV testing
- measure
- Management preference: women's preference for HPV or repeat Pap testing measured by a Decision Aid.
- measure
- Decision Aid evaluation: Measure the impact of the DA of knowledge, decisional conflict, and satisfaction with decision making
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available