Psychosocial Effect of HPV Positivity
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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 |
- 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
- 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 |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Women who are unable to provide a consent to participation.
Contacts and Locations| Contact: Hextan YS Ngan, MD | (852)22554265 | hysngan@hku.hk |
| 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 | |
| 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 May 23, 2013