Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00606

2 Trial Registration Date

2018-05-02

i Registration Status

Prospective

3 Secondary IDs

2.1

4 Source(s) of Funding

AIDS Trust Fund

5 Primary Sponsor

Stanley Ho Centre for Emerging Infectious Diseases

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible 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, New Territories, 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

8 Research 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, New Territories, 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

9 Official Scientific Title of the Study

Pre-exposure prophylaxis with on-demand versus daily TDF/FTC in men who have sex with men at high risk of HIV infection – a crossover study

10 Public Title

Pre-exposure prophylaxis with on-demand versus daily TDF/FTC in men who have sex with men at high risk of HIV infection – a crossover study

i Public Title in Chinese 研究名稱

《接觸前預防投藥》交叉研究

11 Short Title (Optional)

Crossover PrEP

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?

2017-01-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.719

14 Medical Condition Being Studied

HIV infection

15 Intervention

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

16 weeks

vi Frequency of the intervention

daily

16 Comparative Treatments

i Description/ name of comparative treatments

HIV prevention / Daily pre-exposure prophylaxis / truvada

ii Dosage form of the comparative treatments

Truvada tablet (Tenofovir 300 mg / Emtricitabine 200 mg)

iii Dosage of the comparative treatments

2 tablets before sex, and 1 tablet at 24 and then 48 hours afterwards

iv Duration of the comparative treatments

16 weeks

v Frequency of the comparative treatments

on demand

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

men who have sex with men (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

referral from an HIV counselling service

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

Interventional

19 Study Design

i Randomization

Randomized

Please specify

computer-generated random sequence

ii Nature of control

Dose comparison

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Crossover

v Study Phase

4

Please specify

vi Study Objectives (Optional)

(a) compare the adherence between on-demand and daily PrEP; (b) examine the preferred regimen; (c) characterise the pattern of risk compensation following PrEP

20 Anticipated trial start date

2018-07-01

21 Target Sample Size

90

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Adherence rate

ii The metric or method of measurement used

no. of tablets actually taken / no. of tablets required in the protocol

iii The timepoint(s) of primary interest

Week 0 - 34

Primary Outcome

i The Name of the outcome

Coverage of unprotected sex episodes by PrEP

ii The metric or method of measurement used

no. unprotected sex covered by PrEP / no. unprotected sex

iii The timepoint(s) of primary interest

Weeks 0 - 34

24 Secondary Outcome

i The Name of the outcome

Proportion fully adherent to the protocol

ii The metric or method of measurement used

no. visits actually attended / no. visits required in the protocol

iii The timepoint(s) of primary interest

Week 34

Secondary Outcome

i The Name of the outcome

Discontinuation rate

ii The metric or method of measurement used

no. of dropouts / no. enrolled

iii The timepoint(s) of primary interest

Week 34

Secondary Outcome

i The Name of the outcome

Rate of risk compensation

ii The metric or method of measurement used

STI incidence

iii The timepoint(s) of primary interest

Weeks 0 - 34

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-08-13

27 Primary Registry and Trial Identifying Number

ChiCTR1800016100

28 Date of Registration in Primary Registry

2018-05-02

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Trial History Detail on 2018-12-11