Psychosocial Effect of HPV Positivity

NCT01459289 | Unknown

• 1 other identifier: UW11-327
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

leaflet

ACTIVE COMPARATOR

Other: leaflet

counseling

ACTIVE COMPARATOR

Other: counseling and leaflet

Interventions

leaflet OTHER

leaflet

counseling and leaflet OTHER

counseling

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Women who are unable to provide a consent to participation.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Department of Obstetrics & Gynaecology, The University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hextan YS Ngan, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hextan YS Ngan, MD

CONTACT

(852)22554265; hysngan@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 25, 2011

Record last verified: 2011-10

Locations

CN (1)