Human PapillomavirusNCT01459289
Psychosocial Effect of HPV Positivity
A study testing leaflet and counseling and leaflet in people with Human Papillomavirus, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- leaflet and counseling and leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Adult
Who may be able to join
- 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
Who cannot join
- Women who are unable to provide a consent to participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynaecology, The University of Hong Kong
Hong Kong
Ngan, hysngan@hku.hk
Hextan Ngan, MD
About this study
Official title: The Psychosocial Effect of Testing Positive for HPV on Hong Kong Chinese Women With Normal Cervical Cytology
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
- Being tested
- leaflet, counseling and leaflet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leafletOther
counseling and leafletOther
| Study group | Role | What they receive |
|---|---|---|
| leaflet | Active comparator | Not described Receives: Other: leaflet |
| counseling | Active comparator | Not described Receives: Other: counseling and leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in anxiety to 6 months
Anxiety meausred by the Hospital Anxiety and Depression Scale
Measured: 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
Depression will be measured by the Hospital Anxiety and Depression Scale
Measured: Level of depression will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Hextan YS Ngan, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459289
- Sponsor's protocol ID
- UW11-327
- Status last verified
- Oct 2011
- First submitted
- 15 Sep 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychosocial Effect of Testing Positive for HPV on Hong Kong Chinese Women With Normal Cervical Cytology
- ClinicalTrials.gov ID
- NCT01459289
- Acronym / sponsor ID
- UW11-327
- Conditions
- Human Papillomavirus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| leaflet | Active comparator | Other: leaflet |
| counseling | Active comparator | Other: counseling and leaflet |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Women who are unable to provide a consent to participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leaflet | Other | leaflet |
| counseling and leaflet | Other | counseling |
Primary outcome
Change from baseline in anxiety to 6 months
Time frame: 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
1 secondary outcome
Change from baseline in depression to 6 months
Time frame: Level of depression will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hextan YS Ngan, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leaflet and counseling and leaflet in people with Human Papillomavirus, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hextan YS Ngan, MD ((852)22554265, hysngan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in anxiety to 6 months (time frame: Level of anxiety will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2011.