Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00600

2 Trial Registration Date

2018-04-10

i Registration Status

Prospective

3 Secondary IDs

2018.002

4 Source(s) of Funding

Health Care Promotion Scheme

5 Primary Sponsor

Food and Health Bureau

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Wong Cho Lee

ii Address

Room 824, 8/F, Esther Lee Building, The Chinese University of Hong Kong

iii Phone

39438166

iv Email

jojowong@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Cho Lee Wong

ii Address

Room 824, 8/F, Esther Lee Building, The Chinese University of Hong Kong

iii Phone

39438166

iv Email

jojowong@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asians women: A randomized controlled trial

10 Public Title

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asians women: A randomized controlled trial

i Public Title in Chinese 研究名稱

Not applicable

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-03-09

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.002

14 Medical Condition Being Studied

cervical cancer

15 Intervention

i Types of intervention

Other

Please specify

Community health worker led multimedia intervention

ii Description/ name of Intervention/article

The intervention has two components: (1) a multimedia education tested by our team members in an earlier study and (2) monthly telephone follow-up and navigation assistance.

(1) Multimedia education
The trained CHW will deliver two half-hour health talk using a PowerPoint presentation, which covers the following topics: 1) definition of cervical cancer; risk factors, signs, and symptoms of cervical cancer, 3) myths and misconceptions about cervical cancer, 4) preventive measures for cervical cancer, and 5) available preventive measures and service providers in Hong Kong. Participants will then be asked to watch a four-minute video clip to reinforce the information they received. At the end of the health talk, participants will receive an information booklet about cervical cancer that details the health content covered in the health talk. The CHW will discuss the booklet with the participants and instruct them on its use.

(2) Telephone follow-up and navigation assistance
For the three months following the multimedia education, the CHWs will make a monthly telephone follow up to reinforce the knowledge of participants and motivate them to undergo cervical cancer screening.
CHWs will also offer navigation assistance, including making a screening appointment, accompanying participants to undergo screening, and completing the paperwork related to the screening.

iii Dosage form of the intervention

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

3 months

vi Frequency of the intervention

1

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Not applicable

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) Self-identifies as South Asian (from Pakistan, India, or Nepal); (2) aged 25 or older who ever had sex; (3) never had a Pap test or has not undertaken cancer screening in the last five years, (4) have not reported being diagnosed with cancer; (5) have not attended any intervention or education program related to cervical cancer screening in the previous year; and (6) able to communicate with English, Urdu, Nepali, Punjabi or Hindi and read English, Urdu, Nepali, or Punjabi.

ii Exclusion Criteria

Those who enrolled and participated in a project titled ‘Effect of a family-based multimedia intervention on the uptake of colorectal cancer screening among South Asian older adults in Hong Kong: a randomized control trial’ will be excluded.

iii Age Minimum

25

iv Age Maximum

999

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Cluster-randomized, wait-list controlled trial

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-09-01

21 Target Sample Size

400

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Cervical screening uptake

ii The metric or method of measurement used

A receipt of the screening test

iii The timepoint(s) of primary interest

3 months post intervention

24 Secondary Outcome

i The Name of the outcome

Readiness to undergo screening

ii The metric or method of measurement used

Participants will be asked regarding their readiness to undergo a Pap test

iii The timepoint(s) of primary interest

Immediate and three months post-intervention

Secondary Outcome

i The Name of the outcome

Cervical cancer screening belief

ii The metric or method of measurement used

The cervical cancer screening belief scale

iii The timepoint(s) of primary interest

Immediate and three months post-intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2022-03-11

27 Primary Registry and Trial Identifying Number

ChiCTR1800015671

28 Date of Registration in Primary Registry

2018-04-10

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Trial History Detail on 2020-03-10