Viral suppression and HIV transmission in serodiscordant male couples: an international, prospective, observational, cohort study.

BACKGROUND: Evidence on viral load and HIV transmission risk in HIV-serodiscordant male homosexual couples is limited to one published study. We calculated transmission rates in couples reporting condomless anal intercourse (CLAI), when HIV-positive partners were virally suppressed, and daily pre-exposure prophylaxis (PrEP) was not used by HIV-negative partners. METHODS: In the Opposites Attract observational cohort study, serodiscordant male homosexual couples were recruited from 13 clinics in Australia, one in Brazil, and one in Thailand. At study visits, HIV-negative partners provided information on sexual behaviour and were tested for HIV and sexually transmitted infections; HIV-positive partners had HIV viral load tests, CD4 cell count, and sexually transmitted infection tests done. Viral suppression was defined as less than 200 copies per mL. Linked within-couple HIV transmissions were identified with phylogenetic analysis. Incidence was calculated per couple-year of follow-up, focusing on periods with CLAI, no use of daily PrEP, and viral suppression. One-sided upper 95% CI limits for HIV transmission rates were calculated with exact Poisson methods. FINDINGS: From May 8, 2012, to March 31, 2016, in Australia, and May 7, 2014, to March 31, 2016, in Brazil and Thailand, 358 couples were enrolled. 343 couples had at least one follow-up visit and were followed up for 588·4 couple-years. 258 (75%) of 343 HIV-positive partners had viral loads consistently less than 200 copies per mL and 115 (34%) of 343 HIV-negative partners used daily PrEP during follow-up. 253 (74%) of 343 couples reported within-couple CLAI during follow-up, with a total of 16 800 CLAI acts. Three new HIV infections occurred but none were phylogenetically linked. There were 232·2 couple-years of follow-up and 12 447 CLAI acts in periods when CLAI was reported, HIV-positive partners were virally suppressed, and HIV-negative partners did not use daily PrEP, resulting in an upper CI limit of 1·59 per 100 couple-years of follow-up for transmission rate. INTERPRETATION: HIV treatment as prevention is effective in men who have sex with men. Increasing HIV testing and linking to immediate treatment is an important strategy in HIV prevention in homosexual men. FUNDING: National Health and Medical Research Council; amfAR, The Foundation for AIDS Research; ViiV Healthcare; and Gilead Sciences.

Understanding the Targeting and Uptake of HIV Testing Among Gay and Bisexual Men Attending Sexual Health Clinics.

We assessed trends in HIV testing outcomes during a period of clinic-based initiatives introduced to increase HIV testing among gay and bisexual men (GBM) attending sexual health clinics (SHCs) in New South Wales (NSW). A cohort of 25,487 HIV-negative GBM attending 32 SHCs in NSW (2009-2015) was classified into six sub-groups each year based on client-type (new/existing), risk-status (low/high-risk), and any recent HIV testing. Poisson regression methods were used to assess HIV testing outcomes in sub-groups of GBM. HIV testing outcomes and the sub-groups with greatest statistically significant annual increases were: individuals attending (26% in high-risk existing clients with recent testing); testing uptake (4% in low-risk existing clients with no recent testing); testing frequency (6% in low-risk existing clients with no recent testing and 5% in high-risk existing clients with recent testing); and total tests (31% in high-risk existing clients with recent testing). High-risk existing clients with recent testing had a 13% annual increase in the proportional contribution to total tests. Our findings show improved targeting of testing to high-risk GBM at NSW SHCs. The clinic-based initiatives should be considered for translation to other similar settings.

Biological and Behavioral Factors Associated With Positive Chlamydia Retests.

BACKGROUND: Repeat chlamydia detection after treatment is common, and there is concern that treatment failure may be a cause. METHODS: Within a randomized trial, we established a prospective cohort of 600 participants with anogenital chlamydia diagnoses (200 each of women, heterosexual men, and men who have sex with men [MSM]). Participants were invited for repeat testing at 3 months and to complete a behavioral survey at 4 months. Positive samples were analyzed for organism DNA load and genovar. We estimated repeat chlamydia positivity, reinfection and treatment failure rates, and investigated the biological and behavioral factors associated with a repeat positive test. RESULTS: A total of 290 participants (100 women, 89 heterosexual men, 101 MSM) were retested at 1 to 4 months, with 43 repeat positives, including 26 classed as reinfection and 9 as treatment failures. Comparing MSM with heterosexual men and women combined, repeat positivity was higher (20.8% vs 11.6%, P = 0.04), and treatment failure was higher (6.9% vs 1.1%, P = 0.01), but there was no difference in reinfection rates (11.9% vs 7.4%, P = 0.21). Among MSM, the odds of repeat positivity increased by 90% with each additional log organism load in the original specimen (baseline) (adjusted odds ratio, 1.9; 95% confidence interval, 1.1-3.2). Among heterosexuals, the odds of repeat positivity decreased by 10% with each additional week delay in being retested for chlamydia (adjusted odds ratio, 0.9; 95% confidence interval, 0.8-0.9). CONCLUSIONS: Positive retests were more common among MSM than heterosexuals. Treatment failure was more common in MSM with rectal chlamydia, reinforcing concerns about azithromycin treatment failure.

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.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: The National Health and Medical Research Council, Australia.

HIV testing self-efficacy is associated with higher HIV testing frequency and perceived likelihood to self-test among gay and bisexual men.

Background Regular testing of individuals at higher-risk of HIV is central to current prevention strategies. The aim of the present study was to examine the extent to which confidence in one's perceived ability to undertake various aspects of HIV testing and self-testing (self-efficacy) affected HIV testing outcomes. We assessed factors, including self-efficacy, associated with HIV testing frequency and the likelihood to self-test among gay and bisexual men (GBM). METHODS: Participants were HIV-negative GBM at an increased risk of HIV (more than five partners or condomless anal intercourse in the previous 3 months) enrolled in a randomised controlled trial of HIV self-testing. The baseline questionnaire captured data regarding sociodemographic characteristics, HIV and/or sexually transmissible infection testing history, sexual behaviour, beliefs and attitudes towards HIV and eight items capturing confidence in HIV testing ability that were combined as a single broad measure of HIV testing self-efficacy (α=0.81). Factors associated with three or more HIV tests in the past year and the likelihood of self-testing in the future were determined using logistic regression. RESULTS: Of 354 GBM, 34% reported three or more HIV tests in the past year, and 64% reported being 'very likely' to self-test. Factors independently associated with three or more HIV tests in the past year were: higher self-efficacy (adjusted odds ratio (aOR) 1.08 per unit increase; 95% confidence interval (CI) 1.02-1.14; P=0.004); >10 male partners in the past 6 months (aOR 1.79; 95% CI 1.05-3.04; P=0.031) and higher optimism regarding the effects of HIV treatments on HIV transmission (aOR 1.14; 95% CI 1.00-1.29; P=0.044). Only higher self-efficacy was independently associated with reporting a greater likelihood to self-test in the future (aOR 1.10; 95% CI 1.05-1.15; P < 0.001). CONCLUSIONS: Improving self-efficacy by enhancing GBM's knowledge and experience may lead to higher testing frequency. The self-efficacy measure used in the present study could be useful in identifying GBM likely to face difficulties with HIV testing and self-testing.

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.

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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registration number: ACTRN12613001236785 , registered on November 12, 2013.

Dual Intervention to Increase Chlamydia Retesting: A Randomized Controlled Trial in Three Populations.

INTRODUCTION: Chlamydia retesting 3 months after treatment is recommended to detect reinfections, but retesting rates are typically low. The purpose of this study is to determine if the addition of a postal home collection kit to a short message service (SMS) reminder at 3 months increases the percentage of patients retested for chlamydia at 1-4 months, compared to SMS alone. DESIGN: In this unblinded randomized controlled trial, participants were randomized 1:1 to intervention (home arm) or control (clinic arm) status. SETTING/PARTICIPANTS: Participants included 200 each of women, heterosexual men, and men who have sex with men diagnosed and treated for chlamydia at sexual health services. INTERVENTION: Three months after chlamydia diagnosis, home arm participants received an SMS reminder and postal home collection kit (women, vaginal swab; heterosexual men, Copan UriSwab; men who have sex with men, UriSwab and rectal swab). MAIN OUTCOME MEASURES: The main outcome measures were the percentage of participants retested at 1-4 months after chlamydia diagnosis and the percentage in each arm with repeat positive tests, by risk group and overall, analyzed by intention to treat. Data were collected from 2011 to 2013 and analyzed in 2014. RESULTS: The percentage retested within 1-4 months of chlamydia diagnosis was significantly higher in home versus clinic arm participants among women (64% [66/103] vs 39% [38/97], p<0.001); heterosexual men (56% [57/101] vs 34% [34/99], p=0.002); men who have sex with men (62% [61/98] vs 44% [45/102], p=0.010); and overall (61% [184/302] vs 39% [117/298], p<0.001). The percentage in the home versus clinic arm with repeat positive tests was significantly higher among men who have sex with men (16% [16/98] vs 5% [5/102], p=0.021) and overall (10% [31/302] vs 4% [12/298], p=0.006). CONCLUSIONS: The addition of a postal home collection kit to routine SMS reminders resulted in substantial improvements in chlamydia retesting rates in all three risk groups and detection of more repeat positive tests, compared with SMS alone. Extending the intervention to other primary care settings with low retesting rates should be considered.

SMS reminders improve re-screening in women and heterosexual men with chlamydia infection at Sydney Sexual Health Centre: a before-and-after study.

BACKGROUND: In 2009, Sydney Sexual Health Centre implemented a short message service (SMS) reminder system to improve re-screening after chlamydia infection. SMS reminders were sent at 3 months recommending the patient make an appointment for a re-screen. METHODS: Using a before-and-after study, the authors compared the proportion re-screened within 1-4 months of chlamydia infection in women and heterosexual men who were sent an SMS in January to December 2009 (intervention period) with a 18-month period before the SMS was introduced (before period). The authors used a χ(2) test and multivariate regression. Visitors and sex workers were excluded. RESULTS: In the intervention period, 141 of 343 (41%) patients were diagnosed with chlamydia and sent the SMS reminder. In the before period, 338 patients were diagnosed as having chlamydia and none received a reminder. The following baseline characteristics were significantly different between those sent the SMS in the intervention period and the before period: new patients (82% vs 72%, p=0.02), aged <25 years (51% vs 33% p<0.01), three or more sexual partners in the last 3 months (31% vs 27%, p<0.01) and anogenital symptoms (52% vs 38%, p<0.01). The proportion re-screened 1-4 months after chlamydia infection was significantly higher in people sent the SMS (30%) than the before period (21%), p=0.04, and after adjusting for baseline differences, the OR was 1.57 (95% CI 1.01 to 2.46). CONCLUSIONS: SMS reminders increased re-screening in patients diagnosed as having chlamydia at a sexual health clinic. The clinic now plans to introduce electronic prompts to maximise the uptake of the initiative and consider strategies to further increase re-screening.

Trichomonas vaginalis prevalence increases with remoteness in rural and remote New South Wales, Australia.

BACKGROUND: Trichomonas has been reported to be rare in Australia's major cities while remaining very common in some extremely remote Aboriginal communities. This study examined the Trichomonas prevalence and relationship to remoteness among patients attending sexual health clinics in rural and remote areas of New South Wales, Australia. METHODS: During the period 2009 to June 2010, all women attending sexual health clinics in the Western and Far Western Local Health Districts of New South Wales who agreed to sexually transmitted infection testing were offered Trichomonas testing using an in-house polymerase chain reaction test. Overall prevalence was calculated, and logistic regression was used to determine association with remoteness of residency. RESULTS: Of the 506 women attending during the study period, 356 (70%) were tested. Thirty women (8.4%) tested positive to Trichomonas. Trichomonas infection was independently associated with increasing age, being symptomatic, never having had a previous Papanicolaou smear, and remote residency. CONCLUSIONS: The prevalence of Trichomonas was relatively high among women attending sexual health clinics in rural and remote western New South Wales. Trichomonas was more common among women living more remotely, which may reflect population-level health service use. Testing for Trichomonas should be considered for all women requesting testing for sexually transmitted infections in rural and remote Australia.

Trichomonas vaginalis infection among women in a low prevalence setting.

OBJECTIVES: Trichomonas vaginalis has become rare in Australian cities but remains endemic in some remote regions. We describe the prevalence and associations of infection among women attending an urban Australian sexual health clinic. METHODS: A retrospective case control study was conducted with women diagnosed with T. vaginalis at Sydney Sexual Health Centre between January 1992 and December 2006. Proforma medical records for all women were reviewed to extract demographic, behavioural and diagnostic variables using a predefined data collection instrument. RESULTS: Over the 15-year period, 123 cases of T. vaginalis were diagnosed, with a prevalence of 0.40%. Factors independently associated with infection were older age, vaginitis symptoms (adjusted odds ratio (AOR) 6.47; 95% confidence interval (CI), 3.29-12.7), sex with a partner from outside Australia (AOR 2.33; 95% CI, 1.18-4.62), a concurrent (AOR 3.65; 95% CI, 1.23-10.8) or past (AOR 2.67; 95% CI, 1.28-5.57) sexually transmissible infection, injecting drugs (AOR 7.27; 95% CI, 1.43-36.8), and never having had a Papanicolaou smear (AOR 7.22; 95% CI, 2.81-18.9). CONCLUSIONS: T. vaginalis infection was rare in women attending our urban clinic. Rarity, combined with an association with sex outside Australia, points to imported infections accounting for a large proportion of T. vaginalis infections in an urban population. The association with never having had cervical cancer screening, along with injecting drug use, likely reflects an increased prevalence in those with reduced access to health services or poor health seeking behaviours.