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Psychosocial Effect of HPV Positivity

NCT ID: NCT01459289

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Human Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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leaflet

Group Type ACTIVE_COMPARATOR

leaflet

Intervention Type OTHER

counseling

Group Type ACTIVE_COMPARATOR

counseling and leaflet

Intervention Type OTHER

Interventions

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leaflet

Intervention Type OTHER

counseling and leaflet

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hextan YS Ngan, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Department of Obstetrics & Gynaecology, The University of Hong Kong

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hextan YS Ngan, MD

Role: CONTACT

[email protected]
(852)22554265

Facility Contacts

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Ngan

Role: primary

[email protected]

Other Identifiers

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UW11-327

Identifier Type: -

Identifier Source: org_study_id