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Psychosocial Effect of HPV Positivity

This study is currently recruiting participants.
Verified October 2011 by The University of Hong Kong
Sponsor:
Collaborator:
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01459289
First received: September 15, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes

September 15, 2011
October 21, 2011
October 2011
October 2013   (final data collection date for primary outcome measure)
Change from baseline in anxiety to 6 months [ Time Frame: Level of anxiety will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward. ] [ Designated as safety issue: No ]
Anxiety meausred by the Hospital Anxiety and Depression Scale
Same as current
Complete list of historical versions of study NCT01459289 on ClinicalTrials.gov Archive Site
Change from baseline in depression to 6 months [ Time Frame: Level of depression will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward. ] [ Designated as safety issue: No ]
Depression will be measured by the Hospital Anxiety and Depression Scale
Same as current
Not Provided
Not Provided
 
Psychosocial Effect of HPV Positivity
The Psychosocial Effect of Testing Positive for HPV on Hong Kong Chinese Women With Normal Cervical Cytology

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Human Papillomavirus
  • Other: leaflet
  • Other: counseling and leaflet
  • Active Comparator: leaflet
    Intervention: Other: leaflet
  • Active Comparator: counseling
    Intervention: Other: counseling and leaflet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Ethnic Chinese women who have enrolled in the COCY trial, and whose smear results are normal cytology with HPV positivity
  2. Women who are willing to attend colposcopy
  3. Literate in the Chinese language
  4. Have given a verbal consent to participate in this study

Exclusion Criteria:

  • Women who are unable to provide a consent to participation.
Female
30 Years to 60 Years
Not Provided
Contact: Hextan YS Ngan, MD (852)22554265 hysngan@hku.hk
China
 
NCT01459289
UW11-327
No
The University of Hong Kong
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Principal Investigator: Hextan YS Ngan, MD The University of Hong Kong
The University of Hong Kong
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP