title: Effect of availability of HIV self-testing on HIV testing frequency in gay and bisexual men at high risk of infection (FORTH): a waiting-list randomised controlled trial.
abstract: Frequent testing of individuals at high risk of HIV is central to current prevention strategies. We aimed to determine if HIV self-testing would increase frequency of testing in high-risk gay and bisexual men, with a particular focus on men who delayed testing or had never been tested before.
  
  
  
  In this randomised trial, HIV-negative high-risk gay and bisexual men who reported condomless anal intercourse or more than five male sexual partners in the past 3 months were recruited at three clinical and two community-based sites in Australia. Enrolled participants were randomly assigned (1:1) to the intervention (free HIV self-testing plus facility-based testing) or standard care (facility-based testing only). Participants completed a brief online questionnaire every 3 months, which collected the number of self-tests used and the number and location of facility-based tests, and HIV testing was subsequently sourced from clinical records. The primary outcome of number of HIV tests over 12 months was assessed overall and in two strata: recent (last test ≤2 years ago) and non-recent (>2 years ago or never tested) testers. A statistician who was masked to group allocation analysed the data; analyses included all participants who completed at least one follow-up questionnaire. After the 12 month follow-up, men in the standard care group were offered free self-testing kits for a year. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12613001236785.
  
  
  
  Between Dec 1, 2013, and Feb 5, 2015, 182 men were randomly assigned to self-testing, and 180 to standard care. The analysis population included 178 (98%) men in the self-testing group (174 person-years) and 165 (92%) in the standard care group (162 person-years). Overall, men in the self-testing group had 701 HIV tests (410 self-tests; mean 4·0 tests per year), and men in the standard care group had 313 HIV tests (mean 1·9 tests per year); rate ratio (RR) 2·08 (95% CI 1·82-2·38; p<0·0001). Among recent testers, men in the self-testing group had 627 tests (356 self-tests; mean 4·2 per year), and men in the standard care group had 297 tests (mean 2·1 per year); RR 1·99 (1·73-2·29; p<0·0001). Among non-recent testers, men in the self-testing group had 74 tests (54 self-tests; mean 2·8 per year), and men in the standard care group had 16 tests (mean 0·7 per year); RR 3·95 (2·30-6·78; p<0·0001). The mean number of facility-based HIV tests per year was similar in the self-testing and standard care groups (mean 1·7 vs 1·9 per year, respectively; RR 0·86, 0·74-1·01; p=0·074). No serious adverse events were reported during follow-up.
  
  
  
  HIV self-testing resulted in a two times increase in frequency of testing in gay and bisexual men at high risk of infection, and a nearly four times increase in non-recent testers, compared with standard care, without reducing the frequency of facility-based HIV testing. HIV self-testing should be made more widely available to help increase testing and earlier diagnosis.
  
  
  
  The National Health and Medical Research Council, Australia.
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Muhammad S
authors.initials: MS
authors.lastname: Jamil
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Garrett
authors.initials: G
authors.lastname: Prestage
authors.affiliation: Central Clinical School, Monash University, Melbourne, VIC, Australia; Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Fairley
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Grulich
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Kirsty S
authors.initials: KS
authors.lastname: Smith
authors.affiliation: Central Clinical School, Monash University, Melbourne, VIC, Australia; Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.
authors.forename: Marcus
authors.initials: M
authors.lastname: Chen
authors.affiliation: Centre for Social Research in Health, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Martin
authors.initials: M
authors.lastname: Holt
authors.affiliation: Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW, Australia.
authors.forename: Anna M
authors.initials: AM
authors.lastname: McNulty
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Benjamin R
authors.initials: BR
authors.lastname: Bavinton
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW, Australia.
authors.forename: Damian P
authors.initials: DP
authors.lastname: Conway
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Handan
authors.initials: H
authors.lastname: Wand
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Phillip
authors.initials: P
authors.lastname: Keen
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Jack
authors.initials: J
authors.lastname: Bradley
authors.affiliation: ACON, Sydney, NSW, Australia.
authors.forename: Johann
authors.initials: J
authors.lastname: Kolstee
authors.affiliation: Victorian AIDS Council/Gay Men's Health Centre, Melbourne, VIC, Australia.
authors.forename: Colin
authors.initials: C
authors.lastname: Batrouney
authors.affiliation: Cairns Sexual Health Service, Cairns North, QLD, Australia; James Cook University, Townsville, QLD, Australia.
authors.forename: Darren
authors.initials: D
authors.lastname: Russell
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: Matthew
authors.initials: M
authors.lastname: Law
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
authors.forename: John M
authors.initials: JM
authors.lastname: Kaldor
authors.affiliation: The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia. Electronic address: rguy@kirby.unsw.edu.au.
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Guy
mesh_terms: D000328:Adult; D001315:Australia; D015658:HIV Infections / Q000175:diagnosis*; D018451:Homosexuality, Male / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D057566:Self Report; D012725:Sexual Behavior; D000072339:Sexual and Gender Minorities / Q000706:statistics & numerical data; D014850:Waiting Lists; D055815:Young Adult