Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00533

2 Trial Registration Date

2016-10-22

iRegistration Status

Prospective

3 Secondary IDs

1.2

4 Source(s) of Funding

Council for the AIDS Trust Fund

5 Primary Sponsor

Stanley Ho Centre for Emerging Infectious Diseases

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Shui Shan Lee

ii Address

Room 207,
Postgraduate Education Centre,
Prince of Wales Hospital,
Shatin,
N.T., Hong Kong

iii Phone

22528812

iv Email

sslee@cuhk.edu.hk

v Affiliation

Stanley Ho Centre for Emerging Infectious Diseases

vi Country

Hong Kong

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

i Name

Shui Shan Lee

ii Address

Room 207,
Postgraduate Education Centre,
Prince of Wales Hospital,
Shatin,
N.T., Hong Kong

iii Phone

22528812

iv Email

sslee@cuhk.edu.hk

v Affiliation

Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

A preliminary study on the delivery of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) at high risk of HIV transmission through the application of a self-financed incentivized approach

10 Public Title

A preliminary study on the delivery of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) at high risk of HIV transmission through the application of a self-financed incentivized approach

i Public Title in Chinese 研究名稱

《接觸前預防投藥》交叉研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-09-29

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.470

14 Medical Condition Being Studied

HIV infection

15Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

HIV prevention / Daily pre-exposure prophylaxis / truvada

iii Dosage form of the intervention

Truvada tablet (Tenofovir 300 mg / Emtricitabine 200 mg)

iv Dosage of the intervention

1 tablet

v Duration of the intervention

32 weeks

vi Frequency of the intervention

daily and on-demand

16Comparative 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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

man who have sex with man (MSM)

18 years old or above

able to communicate in written and spoken English or Chinese

inclination to engage in unprotected anal sex

a history of unprotected anal sex, especially as receptive partner, within the preceding 6 months

normally resident in Hong Kong

ii Exclusion Criteria

prisoner

having any form of mental illnesses

inability or refusal to give consent

HIV positive

known renal insufficiency with creatinine clearance <60mL/min

known hepatitis B carrier

iii Age Minimum

18

iv Age Maximum

999

v Gender

Male

18 Study Type

Observational

19Study Design

i Randomization

Not Applicable

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

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-10-21

21 Target Sample Size

70

22 Recruitment Status

Recruiting

23Primary Outcome

iThe Name of the outcome

Acceptability of PrEP

iiThe metric or method of measurement used

proportion accepting the regimen and get started

iiiThe timepoint(s) of primary interest

week 2

Primary Outcome

iThe Name of the outcome

Proportion fully adherent to PrEP

iiThe metric or method of measurement used

no. fully adherent / no. enrolled

iiiThe timepoint(s) of primary interest

week 32

24Secondary Outcome

iThe Name of the outcome

discontinuation rate

iiThe metric or method of measurement used

no. of dropouts / no. enrolled

iiiThe timepoint(s) of primary interest

week 32

Secondary Outcome

iThe Name of the outcome

coverage of unprotected sex

iiThe metric or method of measurement used

no. of sex acts preceded and followed by a daily tablet

iiiThe timepoint(s) of primary interest

week 0 to 32

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2019-08-13

27 Primary Registry and Trial Identifying Number

ChiCTR-OPC-16009603

28 Date of Registration in Primary Registry

2016-10-22

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Trial History Detail on 2018-12-11