Psychosocial Effect of HPV Positivity

Human Papillomavirus Clinical Trial

Official title:

The Psychosocial Effect of Testing Positive for HPV on Hong Kong Chinese Women With Normal Cervical Cytology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01459289
• Other study ID #: UW11-327
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2011
• Last updated: October 21, 2011
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2011
• Source: The University of Hong Kong
• Contact: Hextan YS Ngan, MD
• Phone: (852)22554265
• Email: hysngan[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Other:
• leaflet

• counseling and leaflet

Locations

Country	Name	City	State
China	Department of Obstetrics & Gynaecology, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in anxiety to 6 months	Anxiety meausred by the Hospital Anxiety and Depression Scale	Level of anxiety will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.	No
Secondary	Change from baseline in depression to 6 months	Depression will be measured by the Hospital Anxiety and Depression Scale	Level of depression will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.	No