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Trial registered on ANZCTR


Registration number
ACTRN12622000524796
Ethics application status
Approved
Date submitted
24/02/2022
Date registered
4/04/2022
Date last updated
4/04/2022
Date data sharing statement initially provided
4/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preferences and Usability of self-test kits for human immunodeficiency virus (HIV) among gay and bisexual men (PUSH study)
Scientific title
Preferences and Usability of self-test kits for HIV among gay and bisexual men
(PUSH study)
Secondary ID [1] 306377 0
None
Universal Trial Number (UTN)
Trial acronym
PUSH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 325197 0
Condition category
Condition code
Infection 322597 322597 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Public Health 322843 322843 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a non-blinded randomised crossover trial with equal numbers of participants randomised to two arms using a computer-generated sequence created by an independent biostatistician. Men were recruited from participating sexual health clinics and asked to test themselves using two HIV self-testing (HIVST) kits (one oral, and one blood-based) in a private room at the clinic following manufacturer-supplied written, graphic, and/or video instructions. One arm received the oral HIVST first, followed by the blood-based HIVST, and the other the reverse. A study nurse observed the participants during self-testing to note if they performed all the necessary steps correctly or made any errors as per a pre-designed checklist. The study nurse did not provide any instructions or advice on how to do the tests to mimic real-world conditions. The oral test required participants to swab their upper and lower gums, and the blood-based test required participants to prick their finger using a built in lancet and collect a drop of blood. No time limits were placed on viewing instructions or conducting the tests, however the study nurses noted if the test results were read in the recommended time period. During the time when the tests were incubating (15-20 minutes) participants were asked to complete part 1 of a questionnaire that captured socio-demographic characteristics, HIV (including conventional and self-testing) and sexually transmitted infection (STI) testing history, and sexual behaviour. After self-testing, participants completed part 2 of the questionnaire which captured ease of use for each self-testing kit overall and for the different steps involved, and ranking of self-tests in the order of preference. The entire process was completed in approx 45-60 minutes and there was no washout period between tests.
Intervention code [1] 322808 0
Early detection / Screening
Intervention code [2] 322996 0
Diagnosis / Prognosis
Comparator / control treatment
Oral HIVST will be the comparator.
Control group
Active

Outcomes
Primary outcome [1] 330389 0
The primary outcome of the study was the ease in performing each HIV self-test (HIVST) which was measured using a five-point Likert scale.


Timepoint [1] 330389 0
After completion of self-testing.
Secondary outcome [1] 406393 0
Preference, measured by the proportion of those who preferred one type of HIVST kit (oral vs blood based). After completing both tests, participants were asked to nominate their preferred HIVST (oral or blood-based HIVST) on a questionnaire that was was designed specifically for this study, and to specify in free text, a reason for their preference.
Timepoint [1] 406393 0
After completion of self-testing.
Secondary outcome [2] 406790 0
Difficulties when performing the HIVST (the proportion of participants who made errors for each step involved in self-testing) as observed and documented by the study nurse, using a checklist that was designed specifically for this study.
Timepoint [2] 406790 0
After completion of self-testing.

Eligibility
Key inclusion criteria
- Men who have sex with men (i.e. ever had sex with a man in their lifetime), and
- Aged 18 years or above, and
- Not living with HIV, and
- Not previously a FORTH study participant, and
- Speak and read English, and
- Able to provide their own consent, and
- Willing to comply with all requirements of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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 test order for each participant was placed in sequentially numbered sealed envelopes. Each envelope was selected in order by the research nurse to maintain the pre-generated random sequence and only opened by the research nurse after enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was created using the random number generator command “uniform()” in Stata 14.0 statistical software and stratified by sites. This process was done in two-steps: First, the test order was determined by creating the randomisation list with 1:1 ratio, participants were randomly allocated to either “oral HIVST” or “blood based HIVST”. This order was reversed at step two. i.e. participants who were randomised to “oral HIVST” first followed by the blood-based HIVST, and the other the reverse.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The overall ease of use, ease of use for different steps for each HIVST and ranking of kits in the order of preference will be based on responses to the questionnaire. The proportion of men reporting the ease of use overall and for different steps for each HIVST will be calculated.
Difficulties in conducting each HIVST will be based on errors documented by study nurses during the different steps of self-testing. An index score will be created for participants’ level of difficulty overall and for the different steps for each HIVST.
For the primary outcome, we will use generalised mixed models with binomial link function to assess if there is a “carry on effect” while accounting for within subject correlations arising from the crossover design (repeated nature of the data). We will stratify our analyses according to high-risk men (i.e. condomless anal sex in the last 6 months and not using PrEP), and frequent testers (i.e. testing for HIV at least every 3 months).
For the secondary outcomes, we will calculate the proportion of men reporting their preferred HIVST and use the exact method based on the binomial distribution to calculate the 95% confidence intervals. We will use descriptive statistics to summarise nurses’ observations of difficulties.
Analyses will be performed using STATA version 16 (StataCorp. 2019, College Station, TX).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
7/01/2019
Date of last participant enrolment
Anticipated
Actual
10/12/2019
Date of last data collection
Anticipated
Actual
10/12/2019
Sample size
Target
300
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21747 0
Melbourne Sexual Health Centre (MSHC) - Carlton
Recruitment hospital [2] 21748 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 36801 0
3053 - Carlton
Recruitment postcode(s) [2] 36802 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 310729 0
Government body
Name [1] 310729 0
Australian National Health and Medical Research Council
Country [1] 310729 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 311953 0
Commercial sector/Industry
Name [1] 311953 0
Atomo Diagnostics Ltd.
Address [1] 311953 0
Level 1, 3-5 George Street,
Leichhardt, NSW 2040
Country [1] 311953 0
Australia
Secondary sponsor category [2] 312040 0
Commercial sector/Industry
Name [2] 312040 0
Orasure Technologies Inc.
Address [2] 312040 0
220 East First Street
Bethlehem, PA USA 18015
Country [2] 312040 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310305 0
South Eastern Sydney Local Health District – Northern Sector Hospital Human Research Ethics Committee
Ethics committee address [1] 310305 0
Ethics committee country [1] 310305 0
Australia
Date submitted for ethics approval [1] 310305 0
09/06/2017
Approval date [1] 310305 0
03/10/2017
Ethics approval number [1] 310305 0
17/147

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117194 0
Dr Kirsty Smith
Address 117194 0
Kirby Institute Level 6, Wallace Wurth Building, Cnr High St & Botany St, UNSW Sydney, Kensington NSW 2052,
Country 117194 0
Australia
Phone 117194 0
+61 421593015
Fax 117194 0
61 2 9385 0920
Email 117194 0
ksmith@kirby.unsw.edu.au
Contact person for public queries
Name 117195 0
Jason Ong
Address 117195 0
Melbourne Sexual Health Centre
580 Swanston Street
Carlton, Victoria 3053
Country 117195 0
Australia
Phone 117195 0
+61 3 9341 6200
Fax 117195 0
+61 3 9341 6279
Email 117195 0
Jason.ong@monash.edu
Contact person for scientific queries
Name 117196 0
Jason Ong
Address 117196 0
Melbourne Sexual Health Centre
580 Swanston Street
Carlton, Victoria 3053
Country 117196 0
Australia
Phone 117196 0
+61 3 9341 6200
Fax 117196 0
+61 3 9341 6279
Email 117196 0
Jason.ong@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data are highly sensitive.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.