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Trial registered on ANZCTR


Registration number
ACTRN12616001387415
Ethics application status
Approved
Date submitted
19/09/2016
Date registered
6/10/2016
Date last updated
8/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
NZ PrEP: A study assessing the feasibility,risks and benefits of prescribing daily Truvada in a sample of men who are at high risk of acquiring HIV
Scientific title
NZ PrEP: A demonstration project assessing the feasibility,acceptability,risks and benefits of prescribing tenofovir/emtricitabine (Truvada) in a sample of gay and bisexual men attending a sexual health clinic in Aotearoa, New Zealand
Secondary ID [1] 290175 0
NIL
Universal Trial Number (UTN)
U1111-1184-7168
Trial acronym
NZ PrEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 300314 0
Condition category
Condition code
Infection 300179 300179 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to assess the implementation of a novel HIV prevention intervention (PrEP or pre-exposure prophylaxis) at Auckland Regional Sexual Health Service (ARSHS) clinics to individuals at high risk of HIV infection. The purpose is reduce new HIV infections in participants.
Specific objectives are to investigate:
a) Acceptability of PrEP for those invited into the study; by measuring adherence; duration; retention;
b) Risk behaviours on PrEP including sexual partnering; condom use; STI and HIV incidence;
c) Factors (socio-demographic and attitudes) associated with PrEP acceptability, adherence, retention and behaviours;
d) The views and experiences of PrEP users including disclosure; stigma; sexual negotiation.

Design: Open-label single-arm treatment evaluation study
Gay and bisexual men who fit the behavioural inclusion criteria of being considered high-risk for acquiring HIV will be invited to participate. Participation will require written informed consent. All participants will be prescribed a fixed-dose co- formulation of tenofovir 300mg/emtrictabine 200mg(Trade name Truvada) for daily administration orally. Participants will be followed up 3 monthly for HIV and STI testing and assessment for possible adverse effects. Participants will also be rquired to complete an on-line behavioural survey at baseline and every 3 months to assess any possible behavioural impacts of taking PrEP.
The sample size will be limited to 150 participants due to requirements that implementation of the study should not adversely impact on operational and budgetry requirements of the Auckland regional Sexual health Service.There will be no control group as previous studies have shown this intervention to be effective and this is intended to be a demonstration project. WHO is encouraging countries to undertake demonstration projects to facilitate understanding of the safety, effectiveness and sustainability of daily oral PrEP and its use as an addition to existing HIV prevention efforts.

Study duration 24 months
Intervention code [1] 295932 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299665 0
To assess efficacy of daily Truvada as pre-exposure prophylaxis of HIV infection by measuring proportion of participants that are HIV seronegative at the end of the study
Timepoint [1] 299665 0
To be assessed at 4 weeks after enrolment and 3 monthly thereafter for 24 months
Primary outcome [2] 299666 0
To assess acceptability of HIV PrEP as HIV prevention by measuring: 1. Adherence: self-report,pharmacy dispensing records and behavioural surveys 2. Average duration of PrEP use: assessed by self-report, behavioural surveys, pharmacy dispensing records:; n.b. “on use” = 4 or more times a week 3. Retention: time to study discontinuation (voluntary or clinician-initiated) The surveys have been designed specifically for this study and have been based on the surveys used in the VicPrEP demonstration project in Victoria, Australia.
Timepoint [2] 299666 0
To be assessed at 4 weeks after enrolment and 3 monthly thereafter for 24 months
Primary outcome [3] 299668 0
To assess the behavioural impact of prescribing PrEP by assessing:

1. Incident diagnoses of gonorrhoea, chlamydia, syphilis, Hepatitis A virus, Hepatitis B virus, Hepatitis C virus: by regular 3 monthly laboratory testing
Timepoint [3] 299668 0
To be assessed at baseline and 3 monthly thereafter for 24 months
Secondary outcome [1] 327778 0
To assess incidence of physical adverse events due to prescription of tenofovir/emtrictabine as HIV PrEP. For example nausea,diarrhoea, rash, raised serum creatinine,elevated liver transmaminases
Timepoint [1] 327778 0
To be assessed at 4 weeks after enrolment and 3 monthly thereafter for 24 months by self-report and monitoring renal and liver biochemistry tests
Secondary outcome [2] 328154 0
To assess the behavioural impact of prescribing PrEP by assessing:

1. Number of sexual partners: self-completed online questionnaire
2. Episodes and rates of condomless anal intercourse: self-completed online questionnaire

The online questionnaire is based on the VicPrEP study and has been adapted for our study
Timepoint [2] 328154 0
To be assessed at baseline and 3 monthly thereafter for 24 months by regular on-line behavioural surveys
Secondary outcome [3] 328155 0
To assess the views and experiences of PrEP users including:

1. Attitudes to PrEP: self-completed online questionnaire

The online questionnaire is based on the VicPrEP study and adapted to our study
Timepoint [3] 328155 0
To be assessed at baseline and 3 monthly thereafter for 24 months by regular on-line behavioural surveys
Secondary outcome [4] 328156 0
To assess the views and experiences of PrEP users including:

2. Disclosure, stigma and sexual negotiation : qualitative interviews with trained staff
Timepoint [4] 328156 0
To be assessed at 6 months and 12 months by trained staff

Eligibility
Key inclusion criteria
To be eligible to participate men will have to:
* Be aged 18 or over and be eligible for funded care in New Zealand
* Be resident in Auckland
* Be willing and able to provide informed written consent for participation
* Be willing and able to take part in all required study procedures
* Be willing to provide telephone number(s) and/or email addresses to be contacted during the study period
* Have reasonable proficiency in written and spoken English (necessary to complete attitude, behavioural and lifestyle surveys)

They must also have the following behavioural eligibility criteria :
* Being likely to have multiple events of condomless anal intercourse (CAS) in the next 3 months (sustained risk) and also have any of the following:
* A regular sexual partner of an HIV-infected man who is not on anti-retroviral therapy or has detectable viral load with whom condomless anal sex has occurred in the previous 3 months OR
* At least one episode of receptive condomless anal intercourse with any casual male partner with HIV infection who is not on anti-retroviral therapy or with a male partner of unknown HIV test status in the previous 3 months OR
* A diagnosis of rectal gonorrhoea or rectal chlamydia during the previous 3 months OR
* Other high-risk behaviour such as a history of methamphetamine use in the previous 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded for any of the following reasons:
* Anyone who is HIV-1 infected at baseline or who has symptoms consistent with acute HIV infection
* Anyone unwilling to adhere to any of the required study procedures including attendance at scheduled assessments.
* Anyone unwilling to provide written consent to participate
* Anyone with an estimated creatinine clearance (glomerular filtration rate [GFR]) of less than 60ml per minute.
* Anyone with clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness)
* Anyone concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal anti-inflammatory drugs / NSAIDs)
* Anyone who has an allergy to tenofovir disoproxil fumarate and/or emtricitabine (based on self-report or recorded).
* Anyone with mental health issues, memory loss or other cognitive impairment or intellectual disability that may compromise participant safety and/or regimen adherence
* Anyone with co-existing factors or conditions that may compromise a participant’s retention in the study (eg incarceration, planned relocation or potential absence from Auckland for a period of 3 months or longer during the course of the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Recruitment will continue until 150 participants have been enrolled or 12 months from the initiation of the study-whichever occurs sooner- to allow for a minimum of 12 months of follow-up time. The proposed sample size is limited by available funding and the requirement that the sexual health service be able to absorb the anticipated demand within its current contracted volumes; however it is large enough to achieve the study aims for an open-label single-arm treatment evaluation study as no randomization and blinding procedures will be used and therefore do not need to be accounted for in analyses.
It is important for reasons of equity and access that participants are representative of the Auckland region community of Takataapui, gay and bisexual men who have sex with men. Previous studies have found that non-European ethnicity is associated with lower rates of retention and adherence to medication and follow-up. Therefore recruitment of the 150 participants will be in quotas: 75 European, 75 non-European (30 Maori, 30 Pacific, 15 Asian).

Power calculation 1: We will have 85% power to detect if retention of non-Europeans at 48 weeks is 60% or lower vs 80% in Europeans if non-Europeans comprise half (n=75) the entry sample.

Power calculation 2: We will have 81% power to detect a change in high risk behaviour from 10% at baseline to 21% at 48 weeks if 120 participants (80%) are retained.

Power calculations were informed by the following data. In a US PrEP demonstration project, patient retention at 48 weeks was 79%, being lower (63%) among African American GBM.18 In a UK PrEP demonstration project, 10% of patients on PrEP at baseline reported 10+ condomless sex partners in the prior 3 months, increasing to 21% at 48 weeks.
The participants’ demographic data will be reviewed when 50% of the sample has been enrolled into the study. Specific community engagement will be arranged to increase and encourage uptake by specific sectors of the community, for example of Tatataapui, Asian or Pacific participants if quotas are not fulfilled.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/12/2016
Actual
28/02/2017
Date of last participant enrolment
Anticipated
5/12/2017
Actual
Date of last data collection
Anticipated
5/12/2018
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 8246 0
New Zealand
State/province [1] 8246 0
Auckland

Funding & Sponsors
Funding source category [1] 294539 0
Commercial sector/Industry
Name [1] 294539 0
Gilead Sciences
Country [1] 294539 0
Australia
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
Greenlane Clinical Centre
214 Greenlane West Rd
Epsom
Auckland 1011
Country
New Zealand
Secondary sponsor category [1] 293410 0
University
Name [1] 293410 0
University of Auckland
Address [1] 293410 0
Gay Men’s Sexual Health research group
School of Population Health, University of Auckland
Tamaki Innovation Campus
Level 3, Building 730, Room 390
Auckland 1142
Country [1] 293410 0
New Zealand
Other collaborator category [1] 279229 0
Charities/Societies/Foundations
Name [1] 279229 0
Body Positive
Address [1] 279229 0
PO Box 68 766
Newton
Auckland 1145
Country [1] 279229 0
New Zealand
Other collaborator category [2] 279230 0
Charities/Societies/Foundations
Name [2] 279230 0
New Zealand AIDS Foundation
Address [2] 279230 0
35 Hargreaves St
St Mary's Bay
Auckland 1011
Country [2] 279230 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295976 0
Northern A Health and Disability ethcis committee
Ethics committee address [1] 295976 0
Ethics committee country [1] 295976 0
New Zealand
Date submitted for ethics approval [1] 295976 0
25/07/2016
Approval date [1] 295976 0
15/09/2016
Ethics approval number [1] 295976 0
16/NTA/112

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1117 1117 0 0
/AnzctrAttachments/371515-HDEC Letter 16NTA112_Approved FULL Application.pdf (Ethics approval)
Attachments [2] 1118 1118 0 0
/AnzctrAttachments/371515-PROTOCOL.docx (Protocol)
Attachments [3] 1561 1561 0 0
/AnzctrAttachments/371515-HDEC Letter 16NTA112AM01_Approved Amendment.pdf (Ethics approval)
Attachments [4] 1562 1562 0 0
/AnzctrAttachments/371515-PROTOCOL.v4.docx (Protocol)

Contacts
Principal investigator
Name 69118 0
Dr Sunita Azariah
Address 69118 0
Auckland Regional Sexual health Service
Greenlane Clinical Centre
214 greenlane West Rd
Epsom
Auckland 1142
Country 69118 0
New Zealand
Phone 69118 0
+64212163975
Fax 69118 0
+6406309783
Email 69118 0
SunitaA@adhb.govt.nz
Contact person for public queries
Name 69119 0
Suzanne Werder
Address 69119 0
Auckland Regional Sexual health Service
Greenlane Clinical Centre
214 greenlane West Rd
Epsom
Auckland 1142
Country 69119 0
New Zealand
Phone 69119 0
+6421545413
Fax 69119 0
+6496309783
Email 69119 0
SWerder@adhb.govt.nz
Contact person for scientific queries
Name 69120 0
Peter Saxton
Address 69120 0
School of Population Health
University of Auckland
Tamaki Innovation Campus
Level 3, Building 730, Room 390
Auckland 1142
Country 69120 0
New Zealand
Phone 69120 0
+649 373 7599
Fax 69120 0
Email 69120 0
p.saxton@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNZPrEP Demonstration Project: Protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) to determine feasibility, acceptability, adverse and behavioural effects of PrEP provision to gay and bisexual men in publicly funded sexual health clinics in Auckland, New Zealand.2019https://dx.doi.org/10.1136/bmjopen-2018-026363
EmbaseAdherence, Sexual Behavior and Sexually Transmitted Infections in a New Zealand Prospective PrEP Cohort: 12 Months Follow-up and Ethnic Disparities.2022https://dx.doi.org/10.1007/s10461-022-03617-5
N.B. These documents automatically identified may not have been verified by the study sponsor.