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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

Phase 3
18 Years
70 Years
Open (Enrolling)
Cervix Neoplasms

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Trial Information

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Psychosocial wellbeing assessed using psychometric scales including (a) global measures of psychological health (STAI, SF36)and (b) measures specific to cervical screening.

Principal Investigator

Kirsten McCaffery, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Sydney


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

January 2004

Completion Date:

April 2008

Related Keywords:

  • Cervix Neoplasms
  • Cervix Neoplasms
  • Vaginal smears
  • Papillomavirus - Human
  • Neoplasms
  • Uterine Cervical Neoplasms