None listed
Conditions
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.
Interventions
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 rep
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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed