Psychosocial Effect of HPV Positivity

Study Overview
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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.

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

Conditions
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Human Papillomavirus

Intervention / Treatment
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* Other: leaflet
* Other: counseling and leaflet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Women who are unable to provide a consent to participation.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: leaflet<br> | Other: leaflet<br> <br> |
| Active Comparator: counseling<br> | Other: counseling and leaflet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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