Psychosocial Effect of HPV Positivity

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Human Papillomavirus

Clinical Trial Details

NCT number	NCT01459289
Study type	Interventional
Source	The University of Hong Kong
Contact	Hextan YS Ngan, MD
Phone	(852)22554265
Email	hysngan@hku.hk
Status	Recruiting
Phase	N/A
Start date	October 2011
Completion date	October 2013

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