Psychosocial Effect of HPV Positivity

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01459289

Enrollment

200

Registered

2011-10-25

Start date

2011-10-31

Completion date

2013-10-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus

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.

Interventions

OTHERleaflet

OTHERcounseling and leaflet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactHextan YS Ngan, MD

hysngan@hku.hk(852)22554265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026