Centre For Clinical Research And Biostatistics (CCRB)

Back

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00598

2 Trial Registration Date

2018-04-06

i Registration Status

Prospective

3 Secondary IDs

CU-17-C19

4 Source(s) of Funding

Food and Health Bureau - Commissioned Study

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Elaine Ng

ii Address

Room 415-419, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Tessitories, Hong Kong SAR

iii Phone

22528407

iv Email

elaine_ng@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong SAR

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Eliza Wong

ii Address

Room 418, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Tessitories, Hong Kong SAR

iii Phone

22528772

iv Email

lywong@cuhk.edu.hk

v Affiliation

The Jockey Club School of Public Health and Primary Care , The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Epidemiology of Human Papillomavirus (HPV) Infection among HPV-vaccinated Young Adult Female in Hong Kong

10 Public Title

Epidemiology of Human Papillomavirus (HPV) Infection among HPV-vaccinated Young Adult Female in Hong Kong

i Public Title in Chinese 研究名稱

人類乳頭瘤病毒（HPV）自行採樣測試

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-03-16

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC Ref. No. :2017.041

14 Medical Condition Being Studied

Human Papillomavirus

15 Intervention

i Types of intervention

Other

Please specify

Epidemiology of Human Papillomavirus (HPV) Infection among HPV-vaccinated Young Adult Female

ii Description/ name of Intervention/article

Epidemiology of Human Papillomavirus (HPV) Infection among HPV-vaccinated Young Adult Female

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Hong Kong Chinese with Hong Kong Identity Card

Age ≥ 20 years old

Able to speak Cantonese

Able to give informed verbal consent

ii Exclusion Criteria

Age below 20 years old

Unable to speak Cantonese

Unable to understand and give informed verbal consent for the study

iii Age Minimum

20

iv Age Maximum

999

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-04-10

21 Target Sample Size

500

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

To investigate the prevalence of HPV infection in vaccinated female

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

To investigate the genotypes of HPV infection in those with HPV infection of vaccinated female

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

Secondary Outcome

i The Name of the outcome

To explore the lifestyle behavior including the uptake rate of Pap smear screening and its associated factors as well as sexual activity pattern in vaccinated female; and

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

Secondary Outcome

i The Name of the outcome

To assess the acceptability and preferences of self-HPV self-sampling as an alternative cervical screening option in vaccinated female

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-05-20

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

Back

Trial History Detail on 2018-04-06