ANZCTR - Registration

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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]

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

Condition category

Condition code

Infection

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]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

To be assessed at 4 weeks after enrolment and 3 monthly thereafter for 24 months

Primary outcome [2]

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]

To be assessed at 4 weeks after enrolment and 3 monthly thereafter for 24 months

Primary outcome [3]

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]

To be assessed at baseline and 3 monthly thereafter for 24 months

Secondary outcome [1]

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]

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]

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]

To be assessed at baseline and 3 monthly thereafter for 24 months by regular on-line behavioural surveys

Secondary outcome [3]

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]

To be assessed at baseline and 3 monthly thereafter for 24 months by regular on-line behavioural surveys

Secondary outcome [4]

To assess the views and experiences of PrEP users including:

2. Disclosure, stigma and sexual negotiation : qualitative interviews with trained staff

Timepoint [4]

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Gilead Sciences

Address [1]

Level 6
471 St Kilda Rd
Melbourne
VIC 3181

Country [1]

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]

University

Name [1]

University of Auckland

Address [1]

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]

New Zealand

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Body Positive

Address [1]

PO Box 68 766
Newton
Auckland 1145

Country [1]

New Zealand

Other collaborator category [2]

Charities/Societies/Foundations

Name [2]

New Zealand AIDS Foundation

Address [2]

35 Hargreaves St
St Mary's Bay
Auckland 1011

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability ethcis committee

Ethics committee address [1]

Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

25/07/2016

Approval date [1]

15/09/2016

Ethics approval number [1]

16/NTA/112

Summary

Brief summary

The aim of this study is to evaluate the feasibility of prescribing a medication called Truvada daily to a sample of gay and bisexual men at high risk of acquiring HIV to prevent them acquiring HIV infection.
Objectives are to assess the acceptability of daily PrEP by measuring adherence to medication, average duration of taking PrEP and average study retention time for participants.
We also wish to assess the behavioural impact of taking daily PrEP including sexual partnering and condom use on participants.
This will involve following participants 3 monthly for STI and HIV testing, assessment of adherence to medication, recording adverse effects and will involve participants completing a behavioural on-line survey at baseline and 3 monthly.
The sample size will be 150 participants and the study duration will be over 24 months.

Trial website

NZPrEP.org

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/371515-HDEC Letter 16NTA112_Approved FULL Application.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/371515-PROTOCOL.docx (Protocol)

Attachments [3]

/AnzctrAttachments/371515-HDEC Letter 16NTA112AM01_Approved Amendment.pdf (Ethics approval)

Attachments [4]

/AnzctrAttachments/371515-PROTOCOL.v4.docx (Protocol)

Contacts

Principal investigator

Name

Dr Sunita Azariah

Address

Auckland Regional Sexual health Service
Greenlane Clinical Centre
214 greenlane West Rd
Epsom
Auckland 1142

Country

New Zealand

Phone

+64212163975

Fax

+6406309783

[email protected]

Contact person for public queries

Name

Ms Suzanne Werder

Address

Auckland Regional Sexual health Service
Greenlane Clinical Centre
214 greenlane West Rd
Epsom
Auckland 1142

Country

New Zealand

Phone

+6421545413

Fax

+6496309783

[email protected]

Contact person for scientific queries

Name

Dr Peter Saxton

Address

School of Population Health
University of Auckland
Tamaki Innovation Campus
Level 3, Building 730, Room 390
Auckland 1142

Country

New Zealand

Phone

+649 373 7599

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23457	Study protocol	BMJ Open Jun 2019, 9 (6) e026363; DOI: 10.1136/bmjopen-2018-026363

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4031	Plain language summary	No		Study completed preliminary results available
4627	Study results article	Yes		Study completed Preliminary baseline data has bee... [More Details]	371515-(Uploaded-11-02-2019-10-40-30)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Adherence, Sexual Behavior and Sexually Transmitted Infections in a New Zealand Prospective PrEP Cohort: 12 Months Follow-up and Ethnic Disparities.	2022	https://dx.doi.org/10.1007/s10461-022-03617-5
Embase	NZPrEP 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.	2019	https://dx.doi.org/10.1136/bmjopen-2018-026363

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically