Psychosocial Effect of HPV Positivity

Not Applicable

• Conditions: Human Papillomavirus
• Interventions: Other: leaflet; Other: counseling and leaflet

• Registration Number: NCT01459289
• Lead Sponsor: The University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-15
• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-21
• Last Update Submitted: 2011-10-21
• Study First Posted: 2011-10-25
• Last Update Posted: 2011-10-25
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
leaflet	leaflet	-
counseling	counseling and leaflet	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in anxiety to 6 months	Level of anxiety will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.	Anxiety meausred by the Hospital Anxiety and Depression Scale

Secondary Outcome Measures

Name	Time	Method
Change from baseline in depression to 6 months	Level of depression will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.	Depression will be measured by the Hospital Anxiety and Depression Scale

Trial Locations

Locations (1)

Department of Obstetrics & Gynaecology, The University of Hong Kong; 🇨🇳 Hong Kong, China