Psychosocial Effect of HPV Positivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by The University of Hong Kong.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Human Papillomavirus
Other: leaflet
Other: counseling and leaflet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: The Psychosocial Effect of Testing Positive for HPV on Hong Kong Chinese Women With Normal Cervical Cytology

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: leaflet Other: leaflet
Active Comparator: counseling Other: counseling and leaflet

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459289

Contacts
Contact: Hextan YS Ngan, MD (852)22554265 hysngan@hku.hk

Locations
China
Department of Obstetrics & Gynaecology, The University of Hong Kong Recruiting
Hong Kong, China
Contact: Ngan       hysngan@hku.hk   
Principal Investigator: Hextan Ngan, MD         
Sub-Investigator: Tracy Kwan, PhD         
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Investigators
Principal Investigator: Hextan YS Ngan, MD The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01459289     History of Changes
Other Study ID Numbers: UW11-327
Study First Received: September 15, 2011
Last Updated: October 21, 2011
Health Authority: Hong Kong: Ethics Committee

ClinicalTrials.gov processed this record on August 28, 2014