Innovative approaches to cervical cancer screening in low- and middle-income countries.

The estimated cervical cancer burden is over ten-fold greater in low- and middle-income countries (LMICs) than in high-income countries. This health gap is thought to be primarily due to limited access to effective screening and treatment programs for cervical pre-cancer and cancer in such settings. The World Health Organization advocates a policy of 'screen and treat' approach to cervical screening in LMICs and subsequently visual inspection of the cervix with acetic acid (VIA) or Lugo's iodine (VILI), followed by ablative cervical cryotherapy if indicated, and this policy has been implemented in many high-burden settings. The performance of VIA/VILI as a primary screening tool for the detection of cervical pre-cancer and cancer has, however, been inconsistent. Recently, many high-income countries have integrated HPV-DNA testing into their cervical cancer screening programs. The comparatively high cost and resource requirements of HPV-based screening have to date prevented many LMICs from doing the same. A significant development has been the entrance of innovative, easy-to-use and highly accurate HPV tests that can be provided at point of care; these could enable LMICs to implement 'test and treat' approaches for cervical cancer screening.

Ambiguous bodies, uncertain diseases: knowledge of cervical cancer in Papua New Guinea.

OBJECTIVES: Within their local realities, people experience and interpret disease in diverse ways that do not necessarily correlate or converge with Western biomedical interventions. In the high cervical cancer burden setting of Papua New Guinea, understanding how people experience and interpret cervical cancer is necessary for effective intervention. Drawing on work by Street on the production of unstable biomedical knowledge, we explored how ambiguity and uncertainty, coupled with cultural taboos and linguistic limitations, affect what and how people 'know' about women's reproductive organs and their associated disease. DESIGN: A qualitative research approach was used to explore and understand how people in PNG articulate matters of health and disease as they relate to cervical cancer and HPV infection. Specifically, how unstable biomedical knowledge is produced and sustained. We employed a mixed-methods approach in collecting data from 208 (147 women) participants between 2011 and 2012 across 3 provinces in PNG. RESULTS: We found that knowledge and awareness about cervical cancer were poor. Five thematic areas emerged in our analysis, which included the gendered knowledge of women's reproductive health, the burden of cervical cancer in the community and the role (or limitation) of language. We further identified four ways in which ambiguity and uncertainty operate on both sociocultural and biological levels, and in the intersection between to produce unstable biomedical knowledge. These included poor knowledge of where the cervix is located and the uncertainty or unreliability of (lay) diagnoses of disease. CONCLUSION: Local understandings of cervical cancer reflected the limitations of Tok Pisin as a lingua franca as well as the wider uncertain biomedical environment where diagnoses are assembled and shared. There is a clear need to improve understanding of the female reproductive organs in order that people, women in particular, can be better informed about cervical cancer and ultimately better receptive to intervention strategies.

Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens.

The World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both specimen types were tested at the point of care by using the Xpert HPV test. Women were given their cervical test result the same day. Those with a positive hrHPV test and positive examination upon visual inspection of the cervix with acetic acid were offered same-day cervical cryotherapy. A total of 1,005 women were enrolled, with 124 (12.3%; 95% confidence interval [CI], 10.3%, 14.4%) being positive for any hrHPV infection. There was a 99.4% overall percent agreement (OPA) between vaginal and cervical tests for HPV-16 (95% CI, 98.9%, 99.9%), a 98.5% OPA for HPV-18/45 (95% CI, 97.7%, 99.3%), a 94.4% OPA for other hrHPV infections (95% CI, 92.9%, 95.9%), and a 93.4% OPA for all hrHPV types combined (95% CI, 91.8%, 95.0%). Self-collected vaginal specimens had excellent agreement with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. This approach provides for the first time an opportunity to incorporate point-of-care hrHPV testing into clinical cervical screening algorithms in high-burden, low-income settings.

A longitudinal cohort study of HIV 'treatment as prevention' in gay, bisexual and other men who have sex with men: the Treatment with Antiretrovirals and their Impact on Positive And Negative men (TAIPAN) study protocol.

BACKGROUND: Australia has increased coverage of antiretroviral treatment (ART) over the past decade, reaching 73% uptake in 2014. While ART reduces AIDS-related deaths, accumulating evidence suggests that it could also bolster prevention efforts by reducing the risk of HIV transmission ('treatment as prevention'). While promising, evidence of community-level impact of treatment as prevention on reducing HIV incidence among gay and bisexual men is limited. We describe a study protocol that aims to determine if scale up of testing and treatment for HIV leads to a reduction in community viraemia and, in turn, if this reduction is temporally associated with a reduction in HIV incidence among gay and bisexual men in Australia's two most populous states. METHODS: Over the period 2009 to 2017, we will establish two cohorts making use of clinical and laboratory data electronically extracted retrospectively and prospectively from 73 health services and laboratories in the states of New South Wales and Victoria. The 'positive cohort' will consist of approximately 13,000 gay and bisexual men (>90% of all people living with HIV). The 'negative cohort' will consist of at least 40,000 HIV-negative gay and bisexual men (approximately half of the total population). Within the negative cohort we will use standard repeat-testing methods to calculate annual HIV incidence. Community prevalence of viraemia will be defined as the proportion of men with a viral load ≥200RNA copies/mm3, which will combine viral load data from the positive cohort and viraemia estimates among those with an undiagnosed HIV infection. Using regression analyses and adjusting for behavioural and demographic factors associated with infection, we will assess the temporal association between the community prevalence of viraemia and the incidence of HIV infection. Further analyses will make use of these cohorts to assess incidence and predictors of treatment initiation, repeat HIV testing, and viral suppression. DISCUSSION: This study will provide important information on whether 'treatment as prevention' is associated with a reduction in HIV incidence at a community level among gay and bisexual men.

The acceptability and cost of a home-based chlamydia retesting strategy: findings from the REACT randomised controlled trial.

BACKGROUND: Chlamydia retesting three months after treatment is recommended to detect reinfections, but retesting rates are typically low. The REACT (retest after Chlamydia trachomatis) randomised trial demonstrated that home-based retesting using postal home-collection kits and SMS reminders, resulted in substantial improvements in retesting rates in women, heterosexual men and men who have sex with men (MSM), with detection of more repeat positive tests compared with SMS reminder alone. In the context of this trial, the acceptability of the home-based strategy was evaluated and the costs of the two strategies were compared. METHODS: REACT participants (200 women, 200 heterosexual men, 200 MSM) were asked to complete an online survey that included home-testing acceptability and preferred methods of retesting. The demographics, sexual behaviour and acceptability of home collection were compared between those preferring home-testing versus clinic-based retesting or no preference, using a chi-square test. The costs to the health system of the clinic-based and home retesting strategies and the cost per infection for each were also compared. RESULTS: Overall 445/600 (74 %) participants completed the survey; 236/445 from the home-testing arm, and 141 of these (60 %) retested at home. The majority of home arm retesters were comfortable having the kit posted to their home (86 %); found it easy to follow the instructions and collect the specimens (96 %); were confident they had collected the specimens correctly (90 %); and reported no problems (70 %). Most (65 %) preferred home retesting, 21 % had no preference and 14 % preferred clinic retesting. Comparing those with a preference for home testing to those who didn't, there were significant differences in being comfortable having a kit sent to their home (p = 0.045); not having been diagnosed with chlamydia previously (p = 0.030); and living with friends (p = 0.034). The overall cost for the home retest pathway was $154 (AUD), compared to $169 for the clinic-based retesting pathway and the cost per repeat infection detected was $1409 vs $3133. CONCLUSIONS: Among individuals initially diagnosed with chlamydia in a sexual health clinic setting, home-based retesting was shown to be highly acceptable, preferred by most participants, and cost-efficient. However some clients preferred clinic-based testing, often due to confidentiality concerns in their home environment. Both options should be provided to maximise retesting rates. TRIAL REGISTRATION: The trial was registered with the Australia New Zealand Clinical Trials Registry on September 9, 2011: ACTRN12611000968976.

Transgressive women don't deserve protection: young men's narratives of sexual violence against women in rural Papua New Guinea.

Sexual violence against women and girls is commonplace in Papua New Guinea (PNG). While the experiences of women are rightly given central place in institutional responses to sexual violence, the men who perpetrate violence are often overlooked, an oversight that undermines the effectiveness of prevention efforts. This paper draws on interviews conducted with young men as part of a qualitative longitudinal study of masculinity and male sexuality in a rural highland area of PNG. It explores one aspect of male sexuality: men's narratives of sexual violence. Most striking from the data is that the collective enactment of sexual violence against women and girls is reported as an everyday and accepted practice amongst young men. However, not all women and girls were described as equally at risk, with those who transgress gender roles and roles inscribed and reinforced by patriarchal structures, at greater risk. To address this situation, efforts to reduce sexual violence against women and girls require an increased focus on male-centred intervention to critically engage with the forms of patriarchal authority that give license to sexual violence. Understanding the perceptions and experiences of men as perpetrators of sexual violence is a critical first step in the process of changing normative perceptions of gender, a task crucial to reducing sexual violence in countries such as PNG.

Risk factors for herpes zoster in a large cohort of unvaccinated older adults: a prospective cohort study.

We analysed data from a prospective cohort of 255,024 adults aged ⩾45 years recruited from 2006-2009 to identify characteristics associated with a zoster diagnosis. Diagnoses were identified by linkage to pharmaceutical treatment and hospitalization records specific for zoster and hazard ratios were estimated. Over 940,583 person-years, 7771 participants had a zoster diagnosis; 253 (3·3%) were hospitalized. After adjusting for age and other factors, characteristics associated with zoster diagnoses included: having a recent immunosuppressive condition [adjusted hazard ratio (aHR) 1·58, 95% confidence interval (CI) 1·32-1·88], female sex (aHR 1·36, 95% CI 1·30-1·43), recent cancer diagnosis (aHR 1·35, 95% CI 1·24-1·46), and severe physical limitation vs. none (aHR 1·33, 95% CI 1·23-1·43). The relative risk of hospitalization for zoster was higher for those with an immunosuppressive condition (aHR 3·78, 95% CI 2·18-6·55), those with cancer (aHR 1·78, 95% CI 1·24-2·56) or with severe physical limitations (aHR 2·50, 95% CI 1·56-4·01). The novel finding of an increased risk of zoster diagnoses and hospitalizations in those with physical limitations should prompt evaluation of the use of zoster vaccine in this population.

Patterns and characteristics of hepatitis C transmission clusters among HIV-positive and HIV-negative individuals in the Australian trial in acute hepatitis C.

BACKGROUND: Injecting drug users remain the population at greatest risk of acquiring hepatitis C virus (HCV) infection, although a recent increase in cases of sexually transmitted HCV infection has been observed among human immunodeficiency virus (HIV)-infected individuals. The extent to which these separate epidemics overlap is unknown. METHODS: The Australian Trial in Acute Hepatitis C (ATAHC) enrolled 163 individuals (29% of whom were HIV infected) with recent HCV infection. E1/HVR1 sequences were used to construct phylogenetic trees demonstrating monophyletic clusters or pairs, and viral epidemic history and phylogeography were assessed using molecular clock analysis. Individual clusters were characterized by clinical and demographic characteristics. RESULTS: Transmission through injection drug use occurred for 73% of subjects, with sexual transmission occurring for 18% (92% of whom were HIV infected). Among 112 individuals with available E1/HVR1 sequences, 23 (20%) were infected with a strain of HCV identical to that of another subject, comprising 4 homologous clusters and 3 monophyletic pairs, the majority of which (78%) were HIV infected. Clusters contained individuals with both injection drug use-related and sex-related acquisition, and in all clusters (except for 1 female HIV-uninfected pair), individuals identified as men who have sex with men, irrespective of HIV status. CONCLUSIONS: This large unique study of HIV-infected and HIV-uninfected individuals with recently acquired HCV infection demonstrates that clustering is common in the HIV-infected population and that it occurred almost invariably among men who have sex with men, irrespective of the actual mode of acquisition. These findings suggest the coexistence of both injection drug use and sexual risk behaviors for individuals in the same social networks and have implications for the development of public health messages. Clinical trial registration. NCT00192569.

Early IL-10 predominant responses are associated with progression to chronic hepatitis C virus infection in injecting drug users.

The critical events in clearance or persistence of hepatitis C virus (HCV) infection are unknown but likely to be determined early in acute infection. Type 1 and type 2 cytokine production was assessed by HCV peptide ELISpot and multiplex in vitro cytokine production assays in longitudinally collected samples from 20 untreated participants enrolled in the Australian Trial in Acute Hepatitis C (ATAHC); a prospective cohort of acute HCV infection (77% injecting drug users, IDU). Significantly higher interleukin-10 (IL-10) production (P = 0.048), in the relative absence of interferon-gamma (IFN-γ) and IL-2 production, was present early in HCV infection in those who progressed to chronic infection. In contrast, viral clearance was associated with a greater magnitude and broader specificity of IFN-γ (magnitude P < 0.001, breadth P = 0.004) and IL-2 responses, in the relative absence of IL-10. Early IL-10 production was correlated with higher HCV RNA level at baseline (P = 0.046) and week 12 (P = 0.018), while IFN-γ and IL-2 production was inversely correlated with HCV RNA level at baseline (IFN-γ P = 0.020, IL-2 P = 0.050) and week 48 (IFN-γ P = 0.045, IL-2 P = 0.026). Intracellular staining (ICS) indicated the HCV-specific IFN-γ response was primarily from CD8(+) T cells and NK cells, whereas IL-10 production was predominantly from monocytes, with a subset of IL-10 producing CD8(+) T cells present only in those who progressed to chronic infection. IL-10, an immunoregulatory cytokine, appears to play a key role in progression to chronic HCV infection.

Male circumcision for HIV prevention in Papua New Guinea: a summary of research evidence and recommendations for public health following a national policy forum.

In 2005, a clinical trial in South Africa found that circumcision of young men could reduce their risk of acquiring HIV (human immunodeficiency virus) infection by over 60%. In the following year, two more trials in Africa confirmed this finding, leading the World Health Organization to recommend male circumcision as a public health strategy for HIV prevention in high-incidence countries. In order to inform public health policy in Papua New Guinea (PNG), two major research projects were initiated with the goals of investigating the status of penile cutting practices and assessing understandings, acceptability, feasibility and cost-effectiveness of male circumcision for HIV prevention. In addition, behavioural surveillance surveys systematically asked questions on penile cutting practices and an ethnographic literature review informed historical perspectives of penile cutting in PNG. Key findings from these research activities were presented at a National Policy Forum on Male Circumcision for HIV Prevention held in Port Moresby in November 2011. The Forum made three key recommendations: (1) the formation of a joint National Department of HealthlNational AIDS Council Secretariat Policy Committee on male circumcision; (2) the establishment of an integrated harm reduction program; and (3) that future policy on wide-scale roll-out of male circumcision for HIV prevention in PNG be informed by a combination of data from (a) male circumcision intervention pilot programs and (b) research on the potential protective effect of other forms of penile cutting.

Attitudes towards new HIV biomedical prevention technologies among a cohort of HIV-negative gay men in Sydney, Australia.

OBJECTIVES: The aim of the study was to explore the awareness of rectal microbicides, the use of pre-exposure prophylaxis (PREP) and the willingness to participate in biomedical HIV prevention trials in a cohort of HIV-negative gay men. METHODS: In a community-based cohort study, HIV-negative homosexually active men in Sydney, Australia were questioned about awareness of rectal microbicides, use of PREP, and willingness to participate in trials of such products. Predictors of awareness and willingness to participate were analysed by logistic regression. Use of PREP was examined prospectively. RESULTS: Overall, 14% had heard of rectal microbicides. Older (P=0.05) and university-educated men (P=0.001) were more likely to have knowledge of rectal microbicides. Almost one-quarter (24%) of men reported that they were likely/very likely to participate in rectal microbicide trials. Among those men with definite opinions on participation, awareness of rectal microbicides was significantly associated with unwillingness to participate [odds ratio (OR) 0.78, 95% confidence interval (CI) 0.65-0.93, P=0.007]. Willingness to participate in trials using antiretroviral drugs (ARVs) to prevent HIV infection was reported by 43% of men, and was higher among those who reported unprotected anal intercourse (UAI) with HIV-positive partners (OR 1.88, 95% CI 0.99-3.56). There was no evidence of current PREP use. CONCLUSIONS: This study demonstrates that Australian gay men have had little experience with PREP use and rectal microbicides. About half would be willing to consider participation in trials using ARVs to prevent HIV infection. Extensive community education and consultation would be required before PREP or rectal microbicides could be trialled in populations of gay Australian men.

Defining high HIV incidence subgroups of Australian homosexual men: implications for conducting HIV prevention trials in low HIV prevalence settings.

OBJECTIVES: The aim of the study was to assess whether subpopulations with sufficiently high HIV incidences for HIV prevention trials can be identified in low HIV incidence settings such as Australia. METHODS: In a community-based cohort study of HIV-negative homosexually active men in Sydney, Australia, potential risk factors associated with an annual HIV incidence of ≥2 per 100 person-years (PY) were identified. A stepwise procedure ranked these factors according to HIV incidence, to create a 'high-incidence' subgroup of participants. Willingness to participate in HIV prevention trials was assessed. RESULTS: Although the incidence in the cohort overall was only 0.78 per 100 PY, nine risk variables were associated with an HIV incidence of 2 per 100 PY or greater. Stepwise inclusion of these variables revealed a 'high-incidence' subgroup of men representing 24% of the total follow-up time with a combined HIV incidence of 2.71 per 100 PY, who reported at least one of three risk factors in the past 6 months. These men were more willing than others to participate in vaccine and antiretroviral therapy HIV prevention trials. CONCLUSIONS: These findings demonstrate that it is possible to identify high HIV incidence subpopulations in low-incidence settings such as Australia, and these men are of above average willingness to participate in HIV prevention trials.

Evaluation of p16/Ki-67 dual-stain cytology performed on self-collected vaginal and clinician-collected cervical specimens for the detection of cervical pre-cancer.

OBJECTIVES: To compare the performance of dual immunostaining of p16INK4a and Ki-67 proteins performed on self-collected vaginal specimens and clinician-collected cervical specimens, and to evaluate the performance of this technique in predicting high-grade disease. METHODS: Women aged 30-59 years (n = 1005) were recruited at two well-women clinics in Papua New Guinea. Each woman provided both cervical and vaginal specimens that were tested for high-risk human papillomavirus (hrHPV) DNA using the Xpert HPV Test (Cepheid) at point of care. A subset of paired cervical and vaginal specimens (n = 243) were selected to undergo CINTec® PLUS (Roche) p16/Ki-67 dual-stain cytology and liquid-based cytology (LBC). RESULTS: Fifty-five pairs (22%) were excluded from further analysis because the smears were not assessable. Of the 189 remaining paired specimens, 74 pairs (39.1%) were positive for one or more hrHPV genotypes. When comparing results of the dual stain, the overall percent agreement, positive and negative percent agreements and κ value between the cervical and vaginal specimens were 87.8% (CI 82.3-92.1%), 64.6% (CI 49.5-77.8%), 95.7% (CI 91.0-98.0%) and 0.65 (CI 0.51-0.79%) respectively. The sensitivity of the dual stain performed on the cervical specimen to predict high-grade disease, determined by LBC, was superior to that of the dual stain performed on the vaginal specimen: 100% (CI 84.6-100%) versus 68.2% (CI 45.1-86.1%). CONCLUSION: Although further evaluation may be warranted, these findings indicate that dual-stain testing of vaginal specimens cannot be advocated as part of cervical screening programmes in low- and middle-income countries. However, dual-stain cytology performed on cervical specimens may have a role in quality assurance in such settings.

Can data from HIV voluntary counselling and testing be used to assess the impact of public health interventions? A literature review.

Routinely collected data from clinical sites offering voluntary counselling and testing (VCT) for HIV diagnosis have been used to evaluate the impact of public health interventions; however, there has been considerable diversity in strategies. To gain an understanding of the outcome of these evaluations and provide the basis for considering methodological issues, we reviewed published studies. Search criteria were met by 20 papers that described 38 interventions, of which 29 were media-related and nine were policy changes. Most (25 of 38) were based on comparisons between two time periods, before and during the intervention, while 13 used multiple time points, including nine that adopted regression methods. About a third (13 out of 38) of the evaluations monitored HIV positivity rates and a small number investigated impact according to sex (six), age (five) and whether clients were new or repeat (three). For the 29 media-related interventions, there was an average 53% increase in the number of HIV tests performed during the intervention compared with beforehand. For policy change interventions, a 35% increase was found. Routinely collected data from VCT sites can be used to evaluate the impact of public health interventions, but attention to methodological issues will maximize their value for evaluation purposes.

A biological model of scabies infection dynamics and treatment informs mass drug administration strategies to increase the likelihood of elimination.

Infections with Sarcoptes scabiei, or scabies, remain common in many disadvantaged populations. Mass drug administration (MDA) has been used in such settings to achieve a rapid reduction in infection and transmission, with the goal of eliminating the public health burden of scabies. While prevalence has been observed to fall substantially following such an intervention, in some instances resurgence of infection to baseline levels has occurred over several years. To explore the biology underpinning this phenomenon, we have developed a theoretical model of scabies life-cycle and transmission dynamics in a homogeneously mixing population, and simulate the impact of mass drug treatment strategies acting on egg and mite life cycle stages (ovicidal) or mites alone (non-ovicidal). In order to investigate the dynamics of the system, we first define and calculate the optimal interval between treatment doses. We calculate the probability of eradication as a function of the number of optimally-timed successive treatment doses and the number of years over which a program is run. For the non-ovicidal intervention, we first show that at least two optimally-timed doses are required to achieve eradication. We then demonstrate that while more doses over a small number of years provides the highest chance of eradication, a similar outcome can be achieved with fewer doses delivered annually over a longer period of time. For the ovicidal intervention, we find that doses should be delivered as close together as possible. This work provides a platform for further research into optimal treatment strategies which may incorporate heterogeneity of transmission, and the interplay between MDA and enhancement of continuing scabies surveillance and treatment strategies.

Evaluation of self-collected vaginal specimens for the detection of high-risk human papillomavirus infection and the prediction of high-grade cervical intraepithelial lesions in a high-burden, low-resource setting.

OBJECTIVES: To compare the performance of self-collected vaginal (V) specimens with clinician-collected cervical (C) specimens for detection of high-risk human papillomavirus (hrHPV) and cervical disease using the Cepheid Xpert HPV, Roche Cobas 4800 HPV and Hologic Aptima HPV assays. METHODS: Women aged 30-59 years (n = 1005) were recruited at two clinics in Papua New Guinea, and they provided specimens for testing at point-of-care using the Xpert HPV Test, and for subsequent testing using the Cobas HPV (n = 981) and Aptima HPV (n = 983) assays. Liquid-based cytology was performed on C specimens to predict underlying high-grade squamous intraepithelial lesions (HSIL). V specimen results of each assay were evaluated against a constructed reference standard and for detection of HSIL or worse. RESULTS: There was substantial (κ >0.6) agreement in hrHPV detection between V and C specimens across all three assays. The sensitivity, specificity, and positive and negative predictive values of Xpert HPV using self-collected V specimens for the detection of HPV type 16 according to the constructed reference standard were 92.1%, 93.1%, 63.6% and 98.9%, respectively; compared with 90.4%, 94.3%, 67.8% and 98.7% for Cobas 4800 HPV; and 63.2%, 97.2%, 75.0% and 95.3% for Aptima HPV. Similar results were observed for all hrHPV types (combined) and for HPV types 18/45, on all three assays. The detection of any hrHPV using self-collected specimens had high sensitivity (86%-92%), specificity (87%-94%) and negative predictive value (>98%) on all assays for HSIL positivity. CONCLUSIONS: Xpert HPV, using self-collected vaginal specimens, has sufficient accuracy for use in point-of-care 'test-and-treat' cervical screening strategies in high-burden, low-resource settings.

A diagnostic evaluation of a molecular assay used for testing and treating anorectal chlamydia and gonorrhoea infections at the point-of-care in Papua New Guinea.

OBJECTIVES: Papua New Guinea has among the highest prevalences of sexually transmissible infections (STIs) globally with no services able to accurately test for anorectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections. Here we prospectively evaluated the diagnostic performance of a molecular CT/NG assay used at the point-of-care (POC) with the aim of enhancing anorectal STI screening and same-day treatment. METHODS: Men who have sex with men, transgender women and female sex workers taking part in Papua New Guinea's first large-scale biobehavioural study were enrolled and asked to provide a self-collected anorectal swab for POC GeneXpert CT/NG testing. Same-day treatment was offered if positive. A convenience sample of 396 unique and randomly selected samples were transported to Australia for comparison using the Cobas 4800 CT/NG test (Roche Molecular Diagnostics, Pleasanton, CA, USA). RESULTS: A total of 326 samples provided valid results by Cobas whereas 70 samples provided invalid results suggesting inhibition. The positive, negative and overall percentage agreements of GeneXpert CT/NG for the detection of C. trachomatis were 96.7% (95% CI 92.3%-98.9%), 95.5% (95% CI 91.3%-98.0%) and 96.0% (95% CI 93.3%-97.8%), and for N. gonorrhoeae were 93.0% (95% CI 86.1%-97.1%), 100.0% (95% CI 98.3%-100.0%) and 97.8% (95% CI 95.6%-99.1%), respectively. CONCLUSIONS: The overall rate of agreement between the GeneXpert and Cobas CT/NG assays was high with 96.0% for C. trachomatis and 97.8% for N. gonorrhoeae. Results from this study data suggest that the GeneXpert CT/NG assay is suitable for testing self-collected anorectal specimens at the POC and that same-day treatment was feasible.

Self-report is a valid measure of circumcision status in homosexual men.

OBJECTIVE: Misreporting of circumcision status may affect observed relationships between circumcision status and HIV or other sexually transmissible infections. As no data exist on the validity of self-reported circumcision status among homosexual men, we investigated the agreement between self-report and examination findings in a subgroup of participants in the Health in Men (HIM) study in Sydney, Australia. METHODS: A subgroup of 240 participants in the community based HIM cohort study attending annual interview agreed to a brief genital examination by a trained study nurse who was unaware of their previous self-reported circumcision status. RESULTS: Five participants reported being uncircumcised at baseline but were classified as circumcised on examination. All participants who self-reported being circumcised were found on examination to be circumcised. Three cases in which the examining study nurse was unsure of participants' circumcision status were excluded. Of the remaining 237 participants, 155 (65.4%) were classified as circumcised on examination, including five men who self identified as uncircumcised. Compared with examination, self-reported circumcision status resulted in a sensitivity of 96.8%, specificity of 100%, positive predictive value of 100% and negative predictive value of 94.3%. The overall agreement between circumcision status on examination and self-report was 97.9% (kappa score, 0.95; p<0.001) CONCLUSION: Self-report was a valid measure of circumcision status in this group of predominantly Anglo gay-community-attached men. We believe our findings can be generalised to similarly aged gay-community-attached men in other developed countries.

Prevalence, incidence and risk factors for pharyngeal chlamydia in the community based Health in Men (HIM) cohort of homosexual men in Sydney, Australia.

OBJECTIVES: To determine the prevalence, incidence and risk factors for pharyngeal Chlamydia trachomatis in the community based Health in Men (HIM) cohort of HIV negative homosexual men in Sydney, Australia. METHODS: From January 2003, all HIM participants were offered annual screening for pharyngeal chlamydia using BD ProbeTec nucleic acid amplification testing (NAAT). Detailed sexual behavioural data were collected every 6 months, and risk factors for infection and hazard ratios were calculated using Cox regression. RESULTS: Among 1427 participants enrolled, the prevalence of pharyngeal chlamydia on initial testing was 1.06% and the incidence rate was 0.58 per 100 person-years. More than 50% of all infections were identified on baseline testing and 68% of men with pharyngeal infection had no evidence of concurrent anogenital chlamydia. There was no association of pharyngeal chlamydia with sore throat. Infection was significantly associated with increasing frequency of receptive penile-oral sex with ejaculation with casual partners (p = 0.009), although approximately half of infections occurred in participants not reporting this risk behaviour. Neither kissing nor oro-anal practices were associated with infection. CONCLUSION: The incidence of pharyngeal chlamydia infection in the HIM study was relatively low; however, the relatively high prevalence on baseline testing compared to incidence suggests a long duration of infection. Occasional screening for pharyngeal chlamydia in homosexual men who frequently practise receptive oral sex with ejaculation may be warranted.

Estimating the risk of blood donation associated with HIV risk behaviours.

A blood donor questionnaire and declaration, with deferral of potential donors at a higher risk of blood-borne infections, was introduced in Australia in the mid-1980s to reduce the risk of donation of HIV-infected blood. However, the absolute risk of HIV transmission through blood donation from high-HIV-risk donors has not been estimated. This study presents a new method of assessing the risk posed to the blood supply by selected HIV risk behaviours. A model was developed to estimate the probability of blood donation during the window period for HIV infection. Five scenarios for blood donors were considered: (1) men who have sex with men (MSM), (2) men who have sex with women in Australia, (3) women who have sex with partners from countries with a high HIV prevalence, (4) men who have sex with commercial sex workers in Australia and (5) people injecting drugs used once in a year. Those estimated to be at highest risk of becoming infected and donating in the window period were MSM. Women who have sex with men from countries of high HIV prevalence are at greater risk than men who have sex with female sex workers from Australia. These three groups under current Australian guidelines are deferred from donating blood for 12 months. In Australia, a single episode of injecting drug use is associated with very low risk of HIV transmission. The model presented in this study can be used to assess the impact of selected individual risk behaviours on the safety of the blood supply.