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Trial registered on ANZCTR


Registration number
ACTRN12613001236785
Ethics application status
Approved
Date submitted
6/11/2013
Date registered
12/11/2013
Date last updated
14/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial (RCT) of home HIV testing to increase HIV testing frequency
Scientific title
A randomised controlled trial of home HIV testing to increase HIV testing frequency among gay men in the home testing arm compared to standard clinic-based HIV testing
Secondary ID [1] 283491 0
None
Universal Trial Number (UTN)
Trial acronym
FORTH: Frequency of Oral Rapid Testing at Home
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV) 290409 0
Condition category
Condition code
Infection 290799 290799 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Home HIV testing - Participants randomised to the intervention arm will have access to home HIV test kits in addition to routine clinic-based HIV and other sexually transmitted infection (STI) testing. They will receive four home HIV test kits with written and video instructions at enrolment. They will be able to request additional home test kits if required during 24 months of follow-up for up-to 12 kits per year. No training will be provided to participants for home HIV testing at enrolment.

The OraQuick In-Home HIV Test (OraSure Technologies Inc., Bethlehem, Pennsylvania, United States) will be used for home HIV testing in this study. It is a rapid self-administered HIV antibody test which is used with an oral fluid specimen and provides a result 20 minutes after specimen collection. The test is approved for home use in the United States (US) by the Food and Drug Administration (FDA). It is not yet approved by the Therapeutic Goods Administration (TGA) of Australia, but can be imported to Australia for personal use and research purposes.

Due to wait-list control design, participants randomised to the control arm (standard clinic-based testing) will also have access to home HIV test kits for one year after initial 12 months of follow-up.
Intervention code [1] 288197 0
Diagnosis / Prognosis
Intervention code [2] 288201 0
Early detection / Screening
Comparator / control treatment
Standard clinic-based HIV testing - Participants randomised to the control arm will have access to routine clinic-based HIV and other STI testing as per standard of care.

Due to wait-list control design, participants in the control arm will also have access to home HIV test kits in the second year of follow-up in addition to routine clinic-based testing.
Control group
Active

Outcomes
Primary outcome [1] 290795 0
Frequency of HIV testing among gay men in the two study arms.

The frequency of HIV testing refers to the number of HIV tests undertaken by each participant during the follow-up period. The frequency of HIV testing will be be based on self-report via 3 monthly online questionnaires. The self-reported information will be validated by comparing against clinic records and the log of home test kits maintained by the researchers.
Timepoint [1] 290795 0
The main trial analysis of the primary outcome using intention-to-treat approach will be performed at 12 months post-randomisation. Additional analyses will be performed at 24 months post-randomisation.
Secondary outcome [1] 305300 0
Frequency of STI testing among gay men in the two study arms.

The number of tests for STIs other than HIV (chlamydia, gonorrhoea, syphilis) will be based on self-report via 3 monthly online questionnaires. The self-reported information will be validated from the clinic records.
Timepoint [1] 305300 0
Main analysis at 12 months post-randomisation and additional analyses at 24 months post-randomisation.
Secondary outcome [2] 305314 0
HIV positivity (new diagnosed infections) in the two study arms.

This outcome will be measured on the basis of laboratory confirmed HIV positive diagnoses during the follow-up period.
Timepoint [2] 305314 0
Main analysis at 12 months post-randomisation and additional analyses at 24 months post-randomisation.
Secondary outcome [3] 305315 0
HIV testing patterns (when, why) in the two study arms.

This outcome will be measured on the basis of information collected via questionnaires (e.g. location of test and the reason for testing).
Timepoint [3] 305315 0
Main analysis at 12 months post-randomisation and additional analyses at 24 months post-randomisation.
Secondary outcome [4] 305316 0
HIV testing process acceptability in the two study arms.


This outcome will be measured on the basis of information collected via questionnaires and in-depth interviews at 24 months.
Timepoint [4] 305316 0
Main analysis at 12 months post-randomisation and additional analyses at 24 months post-randomisation.
Secondary outcome [5] 305317 0
HIV false positive rate in the home HIV testing arm.

A false positive home test is defined as a reactive test with OraQuick In-Home HIV test followed by negative HIV serology at a laboratory. The numerator for this analysis is the number of false positive home test results and the denominator is the number of reactive home test results.
Timepoint [5] 305317 0
Main analysis at 12 months post-randomisation and additional analyses at 24 months post-randomisation.
Secondary outcome [6] 305318 0
Feasibility of gay men using home HIV tests in the home HIV testing arm.

This outcome will be measured on the basis of information collected via questionnaires and in-depth interviews at 24 months.
Timepoint [6] 305318 0
At 24 months post-randomisation.

Eligibility
Key inclusion criteria
Men identifying themselves as gay (men who have sex with men), AND
Aged 18 years or above, AND
Plan to stay in Australia for next 2 years, AND
Any unprotected anal intercourse (UAI) in the last 3 months, OR
>5 partners in the last 3 months
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men known to be HIV-positive or diagnosed as HIV positive at the current clinic visit, OR
Men commencing HIV post-exposure prophylaxis, OR
Men who cannot speak and/or read English, OR
Men who cannot provide their own consent, OR
Unwilling or unable to comply with all the requirements of the study

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants will be recruited at three sexual health clinics and two community-based sites. The study will be advertised through the community sites (in gay press, social media, online advertisements, banners on websites frequented by gay men) and through posters and postcards at the study sites.

Men will not be actively approached for recruitment, but will be required to volunteer at one of the study sites, where they will be enrolled after written informed consent.

Designated trained staff will assess participants’ eligibility through information routinely collected at the clinics or by using a screening template.

After consent, the study staff will pick an opaque randomisation envelope and inform the participant of their study group (home or clinic arm) and obtain detailed contact information including postal address, home phone, mobile number and email address.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomised 1:1 to the intervention (home HIV testing) or control (clinic HIV testing) arm using a minimisation approach.

Randomisation codes will be prepared by a statistician at the Kirby Institute and sealed in opaque envelopes. The codes will be computer generated randomization numbers stratified on the basis of site and testing history (last HIV test less than or greater than 24 months ago).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Wait-list control design - participants randomised to the control arm will switch to the intervention arm in the second year of follow-up so that all the trial participants will have access to home HIV test kits (intervention) in the second year of follow-up
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 288191 0
Government body
Name [1] 288191 0
National Health and Medical Research Council (NHMRC)
Address [1] 288191 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 288191 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Kensington Campus
The University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 286920 0
None
Name [1] 286920 0
Address [1] 286920 0
Country [1] 286920 0
Other collaborator category [1] 277675 0
Other Collaborative groups
Name [1] 277675 0
Sydney Sexual Health Centre
Address [1] 277675 0
Level 3, Nightingale Wing
Sydney Hospital
Macquarie Street
Sydney NSW 2000
Country [1] 277675 0
Australia
Other collaborator category [2] 277676 0
Other Collaborative groups
Name [2] 277676 0
Melbourne Sexual Health Centre
Address [2] 277676 0
580 Swanston Street
Carlton Victoria 3053
Country [2] 277676 0
Australia
Other collaborator category [3] 277677 0
Other Collaborative groups
Name [3] 277677 0
ACON (AIDS Council of NSW)
Address [3] 277677 0
414 Elizabeth Street
Surry Hills NSW 2010
Country [3] 277677 0
Australia
Other collaborator category [4] 277678 0
Other Collaborative groups
Name [4] 277678 0
Victorian AIDS Council/Gay Men's Health Centre
Address [4] 277678 0
6 Claremont Street
South Yarra Victoria 3141
Country [4] 277678 0
Australia
Other collaborator category [5] 277689 0
Other Collaborative groups
Name [5] 277689 0
Cairns Sexual Health Service
Address [5] 277689 0
Cairns North Community Health Precinct
381 Sheridan St
Cairns North QLD 4870
Country [5] 277689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290103 0
South Eastern Sydney Local Health District - Northern Sector
Ethics committee address [1] 290103 0
Room G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Cnr High & Avoca Streets
Randwick NSW 2031
Ethics committee country [1] 290103 0
Australia
Date submitted for ethics approval [1] 290103 0
Approval date [1] 290103 0
13/06/2013
Ethics approval number [1] 290103 0
12/276
Ethics committee name [2] 290104 0
Alfred Health Human Ethics Committee
Ethics committee address [2] 290104 0
Ground Floor, Linay Pavilion
The Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Ethics committee country [2] 290104 0
Australia
Date submitted for ethics approval [2] 290104 0
Approval date [2] 290104 0
18/06/2013
Ethics approval number [2] 290104 0
143/13
Ethics committee name [3] 290106 0
ACON Research Ethics Review Committee
Ethics committee address [3] 290106 0
414 Elizabeth Street
Surry Hills NSW 2010
Ethics committee country [3] 290106 0
Australia
Date submitted for ethics approval [3] 290106 0
Approval date [3] 290106 0
02/07/2013
Ethics approval number [3] 290106 0
2013/06
Ethics committee name [4] 290107 0
Victorian AIDS Council/Gay Men's Health Centre Research Promotion & Ethics Committee
Ethics committee address [4] 290107 0
6 Claremont Street
South Yarra Victoria 3141
Ethics committee country [4] 290107 0
Date submitted for ethics approval [4] 290107 0
Approval date [4] 290107 0
22/07/2013
Ethics approval number [4] 290107 0
13/003

Summary
Brief summary
This randomised controlled trial (RCT) aims to assess the effectiveness, acceptability and feasibility of home HIV testing among gay men in Australia. Approximately 350 high risk gay men (including 50 men who report their last HIV test was more than 24 months ago) will be recruited from clinics and community-based sites and randomised 1:1 to one of the two study arms: home HIV testing arm (intervention); or clinic HIV testing arm (control).

At enrolment, all study procedures will be explained to the participants and they will be required to sign a written consent form which will cover all data collection activities of the trial. The OraQuick In-Home HIV Test will be used for home HIV testing in this study. It is a rapid self-administered over-the-counter (OTC) test which is used with an oral fluid specimen and provides a result 20 minutes after specimen collection. The test is developed by OraSure Technologies Inc., (Bethlehem, Pennsylvania, United States) and is approved for home use in the United States (US) by the Food and Drug Administration (FDA). It is not yet approved by the Therapeutic Goods Administration (TGA) of Australia, but can be imported to Australia for personal use and research purposes.

This is a wait-list control RCT, with each participant followed-up for 24 months after enrolment. After initial 12 months, participants in the clinic HIV testing arm will switch to home HIV testing arm, so that all the participants will have access to home HIV testing in the last 12 months. At enrolment, men in the home testing arm will receive four OraQuick home tests with written and video instructions. Further home tests will be available on request, with a maximum of 12 kits per participant per year. Ongoing support via a 24 hour phone line will be available to men in the home HIV testing arm throughout the study. Men in both arms will have access to routine HIV testing and care at their preferred clinic.

Demographic, sexual behaviour and HIV/STI testing information will be collected from participants through a self-administered questionnaire at enrolment. Every 3 months, brief information on HIV/STI tests and the results will be collected through an online self-administered questionnaire. In addition, HIV/STI test results will be collected from clinics attended by the participants during the study period. At 12 and 24 months, these questionnaires will include additional questions to collect information on acceptability of clinic and home HIV testing and confidence on the performance of home HIV test. At the end of study, selected participants will be invited to participate in in-depth interviews to obtain detailed information about their home test experience and influence on sexual behaviour.
Trial website
www.forth.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43978 0
A/Prof Rebecca Guy
Address 43978 0
The Kirby Institute, UNSW Australia
Wallace Wurth Building
UNSW Sydney, NSW, 2052
Country 43978 0
Australia
Phone 43978 0
+61 2 9385 0978
Fax 43978 0
Email 43978 0
Rguy@kirby.unsw.edu.au
Contact person for public queries
Name 43979 0
A/Prof Rebecca Guy
Address 43979 0
The Kirby Institute, UNSW Australia
Wallace Wurth Building
UNSW Sydney, NSW, 2052
Country 43979 0
Australia
Phone 43979 0
+61 2 9385 0978
Fax 43979 0
Email 43979 0
Rguy@kirby.unsw.edu.au
Contact person for scientific queries
Name 43980 0
A/Prof Rebecca Guy
Address 43980 0
The Kirby Institute, UNSW Australia
Wallace Wurth Building
UNSW Sydney, NSW, 2052
Country 43980 0
Australia
Phone 43980 0
+61 2 9385 0978
Fax 43980 0
Email 43980 0
Rguy@kirby.unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary