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Psychosocial Effect of HPV Positivity

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Unknown

Conditions

Human Papillomavirus

Treatments

Other: counseling and leaflet
Other: leaflet

Study type

Interventional

Funder types

Other

Identifiers

NCT01459289
UW11-327

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

leaflet
Active Comparator group
Treatment:
Other: leaflet
counseling
Active Comparator group
Treatment:
Other: counseling and leaflet

Trial contacts and locations

1

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Central trial contact

Hextan YS Ngan, MD

Data sourced from clinicaltrials.gov

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