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ClinicalTrials.gov Identifier: NCT01459289
Verified October 2011 by The University of Hong Kong. Recruitment status was: Recruiting
The use of HPV testing in cervical screening has raised concerns about the effect of a positive HPV result on women's psychological well being. This is a nested psychosocial study of the COCY trial (IRB No. UW 09-377; PI: Prof Hextan Ngan), with the aim to evaluate the psychosocial impact of HPV positivity on Hong Kong Chinese women and the modulating effects of educational intervention on such impact. Potential participants are identified among those who have joint the COCY trial. Participants will be randomized into two groups, namely the control group or intervention group. The control group participants will receive their smear results and an HPV leaflet by post. The intervention group will receive the leaflet and a counseling session on HPV. Self-administered questionnaires will be used to assess participants' psychological condition at the receipt of the smear results and at two months afterward. It is hypothesized that the level of emotional distress measured at smear result notification will be greater than that at two months afterward for all participants. Furthermore, participants in the intervention group will have lower psychological distress than those in the control group at two months after the receipt of their smear results.
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Ages Eligible for Study:
30 Years to 60 Years (Adult)
Sexes Eligible for Study:
Ethnic Chinese women who have enrolled in the COCY trial, and whose smear results are normal cytology with HPV positivity
Women who are willing to attend colposcopy
Literate in the Chinese language
Have given a verbal consent to participate in this study
Women who are unable to provide a consent to participation.