title: Rationale and design of FORTH: a randomised controlled trial assessing the effectiveness of HIV self-testing in increasing HIV testing frequency among gay and bisexual men.
abstract: BACKGROUND
  Gay and bisexual men (GBM) are a major risk group for HIV acquisition, yet the majority of higher-risk GBM test for HIV less often than recommended (3-6 monthly). HIV self-testing has the potential to increase testing frequency and improve awareness of personal HIV status. HIV self-tests have been approved in some countries, however there are concerns whether self-testing would increase HIV testing frequency enough to compensate for the reduced sensitivity of self-tests in early infection. We describe here a randomised controlled trial to assess the effectiveness of self-testing in increasing HIV testing frequency among higher-risk GBM, and its acceptability.
  
  
  METHODS
  Participants are higher-risk HIV negative GBM (>5 partners or condomless anal intercourse in previous 3 months; n = 350), including 50 GBM who tested for HIV over two years ago or never tested before ('infrequent-testers'). Participants are recruited from sexual health clinics and community-based organisations, and randomised 1:1 to either self-testing or standard-care (routine clinic-based testing) arms. The trial employs a wait-list control design: participants in the standard-care arm switch to self-testing arm in the second year, and gain access to self-test kits. Participants in the self-testing arm receive four oral-fluid self-test kits at enrolment, with additional kits provided on request. Demographics, sexual behaviour and HIV testing preferences are collected at baseline, and the frequency and pattern of HIV and sexually transmissible infection (STI) testing is collected via online 3-monthly questionnaires. The acceptability of self-testing is assessed at 12 months via an online questionnaire and in-depth interviews. A 24-h telephone support is provided, with expedited follow-up of those with reactive self-test results. The primary outcome is HIV testing frequency (mean number of HIV tests per person) over 12 months, and the secondary outcomes are: mean number of STI tests (chlamydia, gonorrhoea, syphilis) per person; reasons for HIV testing; and acceptability of HIV self-testing.
  
  
  CONCLUSIONS
  This is the first trial to evaluate the use of self-testing among GBM in Australia, and the first internationally among infrequent testers. The study will provide evidence on whether self-testing increases HIV testing frequency, and its acceptability among GBM. The findings will improve our understanding of self-testing patterns, and whether GBM supplement or replace their existing testing routine.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trial Registration number: ACTRN12613001236785 , registered on November 12, 2013.
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Mjamil@kirby.unsw.edu.au.
authors.forename: Muhammad S
authors.initials: MS
authors.lastname: Jamil
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Gprestage@kirby.unsw.edu.au.|Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, VIC, Australia. Gprestage@kirby.unsw.edu.au.
authors.forename: Garrett
authors.initials: G
authors.lastname: Prestage
authors.affiliation: Central Clinical School, Monash University, Melbourne, VIC, Australia. cfairley@mshc.org.au.|Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia. cfairley@mshc.org.au.
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Fairley
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Ksmith@kirby.unsw.edu.au.
authors.forename: Kirsty S
authors.initials: KS
authors.lastname: Smith
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Jkaldor@kirby.unsw.edu.au.
authors.forename: John M
authors.initials: JM
authors.lastname: Kaldor
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Agrulich@kirby.unsw.edu.au.
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Grulich
authors.affiliation: Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW, Australia. Anna.McNulty@SESIAHS.HEALTH.NSW.GOV.AU.
authors.forename: Anna M
authors.initials: AM
authors.lastname: McNulty
authors.affiliation: Central Clinical School, Monash University, Melbourne, VIC, Australia. MChen@mshc.org.au.|Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia. MChen@mshc.org.au.
authors.forename: Marcus
authors.initials: M
authors.lastname: Chen
authors.affiliation: Centre for Social Research in Health, UNSW Australia, Sydney, NSW, Australia. m.holt@unsw.edu.au.
authors.forename: Martin
authors.initials: M
authors.lastname: Holt
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Dconway@kirby.unsw.edu.au.
authors.forename: Damian P
authors.initials: DP
authors.lastname: Conway
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. hwand@kirby.unsw.edu.au.
authors.forename: Handan
authors.initials: H
authors.lastname: Wand
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Pkeen@kirby.unsw.edu.au.
authors.forename: Phillip
authors.initials: P
authors.lastname: Keen
authors.affiliation: Victorian AIDS Council/Gay Men's Health Centre, Melbourne, VIC, Australia. Colin.Batrouney@vac.org.au.
authors.forename: Colin
authors.initials: C
authors.lastname: Batrouney
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Jbradley@kirby.unsw.edu.au.
authors.forename: Jack
authors.initials: J
authors.lastname: Bradley
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Bbavinton@kirby.unsw.edu.au.
authors.forename: Benjamin R
authors.initials: BR
authors.lastname: Bavinton
authors.affiliation: ACON, Sydney, NSW, Australia. DRyan@acon.org.au.
authors.forename: Dermot
authors.initials: D
authors.lastname: Ryan
authors.affiliation: Cairns Sexual Health Service, Cairns North, QLD, Australia. Darren.Russell@health.qld.gov.au.|James Cook University, Townsville, QLD, Australia. Darren.Russell@health.qld.gov.au.
authors.forename: Darren
authors.initials: D
authors.lastname: Russell
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. Rguy@kirby.unsw.edu.au.
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Guy
mesh_terms: D000328:Adult; D001315:Australia; D001727:Bisexuality; D005500:Follow-Up Studies; D015658:HIV Infections / Q000175:diagnosis*; D006716:Homosexuality; D015277:Hotlines; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008403:Mass Screening; D009520:New Zealand; D012698:Serologic Tests; D012749:Sexually Transmitted Diseases / Q000175:diagnosis; D011795:Surveys and Questionnaires