Centralization of Pancreaticoduodenectomy: A Systematic Review and Spline Regression Analysis to Recommend Minimum Volume for a Specialist Pancreas Service.

OBJECTIVE: Through a systematic review and spline curve analysis, to better define the minimum volume threshold for hospitals to perform (pancreaticoduodenectomy) and the high-volume center. BACKGROUND: The pancreaticoduodenectomy (PD) is a resource-intensive procedure, with high morbidity and long hospital stays resulting in centralization towards high-volume hospitals; the published definition of high volume remains variable. MATERIALS AND METHODS: Following a systematic review of studies comparing PD outcomes across volume groups, semiparametric regression modeling of morbidity (%), mortality (%), length of stay (days), lymph node harvest (number of nodes), and cost ($USD) as continuous variables were performed and fitted as a smoothed function of splines. If this showed a nonlinear association, then a "zero-crossing" technique was used, which produced "first and second derivatives" to identify volume thresholds. RESULTS: Our analysis of 33 cohort studies (198,377 patients) showed 55 PDs/year and 43 PDs/year were the threshold value required to achieve the lowest morbidity and highest lymph node harvest, with model estimated df 5.154 ( P <0.001) and 8.254 ( P <0.001), respectively. The threshold value for mortality was ~45 PDs/year (model 9.219 ( P <0.001)), with the lowest mortality value (the optimum value) at ~70 PDs/year (ie, a high-volume center). No significant association was observed for cost ( edf =2, P =0.989) and length of stay ( edf =2.04, P =0.099). CONCLUSIONS: There is a significant benefit from the centralization of PD, with 55 PDs/year and 43 PDs/year as the threshold value required to achieve the lowest morbidity and highest lymph node harvest, respectively. To achieve mortality benefit, the minimum procedure threshold is 45 PDs/year, with the lowest and optimum mortality value (ie, a high-volume center) at approximately 70 PDs/year.

Developing and Validating Risk Algorithm for Hypertension in South Africa: Results from a Nationally Representative Cohort (2008-2017).

INTRODUCTION: There is compelling evidence of significant country-level disparities where African countries, particularly South Africa, have the highest hypertension rates in the world. AIM: To develop and validate a simple risk scoring algorithm for hypertension in a large cohort (80,270) of South African men and women. METHODS: Multivariable logistic regression models were used to build our hypertension risk scoring algorithm and validated externally and internally using the standard statistical techniques. We also compared our risk scores with the results from the Framingham risk prediction model for hypertension. RESULTS: Six factors were identified as the significant correlates of hypertension: age, education, obesity, smoking, alcohol intake and exercise. A score of ≥ 25 (out of 57) for men and ≥ 35 (out of 75) for women were selected as the optimum cut-points with 82% (43%) and 83% (49%) sensitivity (specificity) for males and females, respectively in the development datasets. We estimated probabilities of developing hypertension using the Framingham risk prediction model, which were higher among those with higher scores for hypertension. CONCLUSIONS: Identifying, targeting and prioritising individuals at highest risk of hypertension will have significant impact on preventing severe cardiometabolic diseases by scaling up healthy diet and life-style factors. Our six-item risk scoring algorithm may be included as part of hypertension prevention and treatment programs by targeting older individuals with high body fat measurements who are at highest risk of developing hypertension.

Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT).

BACKGROUND: WHO recommends human papillomavirus (HPV) testing and same-day treatment for cervical screening in low-income and middle-income countries (LMICs); however, few published data exist on the validity of the strategy. We aimed to evaluate the clinical performance, treatment completion rates, adverse events profile, and acceptability of a fully integrated strategy, comprising point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation, for screening of cervical cancer in women in Papua New Guinea. METHODS: HPV-STAT was a large-scale, prospective, single-arm intervention trial conducted at two clinical sites in Papua New Guinea. Cervical screening clinics with an on-site consultant gynaecologist were selected in consultation with national and provincial health authorities, church health services, and local stakeholders. Eligible participants were women aged 30-59 years attending cervical screening services at the two clinics, who were willing to comply with study procedures and able to provide written informed consent. Women self-collected vaginal specimens for point-of-care GeneXpert testing (Cepheid, Sunnyvale, CA, USA) for oncogenic HPV types. Women testing positive for HPV underwent pelvic examination followed by same-day thermal ablation or referral for gynaecology review. All HPV-positive women and a 15% random sample of HPV-negative women provided a clinician-collected cervical specimen for liquid-based cytology. The primary outcome was clinical performance (ie, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the strategy for the detection of high-grade squamous intraepithelial lesion (HSIL) or worse. This trial is registered with ISRCTN, ISRCTN13476702. FINDINGS: Between June 5, 2018, and Jan 6, 2020, we recruited 4285 women, 3638 (84·9%) of whom tested negative for HPV and 647 (15·1%) tested positive for one or more oncogenic HPV type. Sensitivity of the algorithm to detect HSIL or worse was 85·4% (95% CI 81·0-89·6), with specificity 89·6% (88·6-90·6), PPV 35·2% (31·6-39·0), and NPV 98·9% (98·6-99·2). Among HPV-positive women, 602 (93·0%) received same-day thermal ablation and 42 (6·5%) were referred for gynaecology review, 37 (88·1%) of whom attended. Acceptability was high among both HPV-positive and HPV-negative women. Among the 329 HPV-positive women who attended a 3-month follow-up visit, 51 (15·5%) reported mild adverse symptoms that resolved in all cases by the follow-up visit. There were no serious adverse events. INTERPRETATION: We conducted the first real-world evaluation of a fully integrated point-of-care HPV self-collect, test, and treat strategy for same-day cervical screening in a LMIC and found it to be effective, acceptable, and safe when implemented at scale in primary health-care facilities in Papua New Guinea. Our findings support the introduction and scale-up of HPV screening and treatment for the control and elimination of cervical cancer in LMICs, as recommended by WHO. FUNDING: Australian National Health and Medical Research Council.

School-Level Variation in Coverage of Co-Administered dTpa and HPV Dose 1 in Three Australian States.

BACKGROUND: Australian adolescents are routinely offered HPV and dTpa (diphtheria, tetanus, pertussis) vaccines simultaneously in the secondary school vaccination program. We identified schools where HPV initiation was lower than dTpa coverage and associated school-level factors across three states. METHODS: HPV vaccination initiation rates and dTpa vaccination coverage in 2016 were calculated using vaccine databases and school enrolment data. A multivariate analysis assessed sociodemographic and school-level factors associated with HPV initiation being >5% absolute lower than dTpa coverage. RESULTS: Of 1280 schools included, the median school-level HPV initiation rate was 85% (interquartile range (IQR):75-90%) and the median dTpa coverage was 86% (IQR:75-92%). Nearly a quarter (24%) of all schools had HPV vaccination initiation >5% lower than dTpa coverage and 11 % had >10% difference. School-level factors independently associated with >5% difference were remote schools (aOR:3.5, 95% CI = 1.7-7.2) and schools in major cities (aOR:1.8, 95% CI = 1.0-3.0), small schools (aOR:3.3, 95% CI = 2.3-5.7), higher socioeconomic advantage (aOR:1.7, 95% CI = 1.1-2.6), and lower proportions of Language-background-other-than-English (aOR:1.9, 95% CI = 1.2-3.0). CONCLUSION: The results identified a quarter of schools had lower HPV than dTpa initiation coverage, which may indicate HPV vaccine hesitancy, and the difference was more likely in socioeconomically advantaged schools. As hesitancy is context specific, it is important to understand the potential drivers of hesitancy and future research needs to understand the reasons driving differential uptake.

Identifying significant contributors for smoking cessation among male prisoners in Australia: results from a randomised clinical trial.

INTRODUCTION: In Australia, an estimated 90% of those entering prison are current tobacco smokers and three-quarters of current prisoners are tobacco smokers. AIMS: To identify factors and their relative contributions to smoking cessation among male prisoners. METHODS: A total of 425 male tobacco smokers with a median age of 32 years in Australian prisons. The primary outcome was continuous abstinence at 3, 6 and 12 months. We measured various sociodemographic characteristics, drug use, psychological distress and the mental and physical health status of the participants. Multivariate logistic regression models and population attributable risks (PAR%) were used to identify the significant factors and their contributions to smoking cessation rates. RESULTS: The median age of participants was 32 years (IQR 25-41 years). High smoking cessation rates were collectively associated with not using drugs, lower psychological distress, good mental health scores and better physical health (PAR%: 93%, 98% and 88% at 3, 6 and 12 months). CONCLUSION: Our study suggests that not using drugs and being in good mental/physical health are the important contributors to continuous abstinence among prisoners. Thus, effective smoking cessation programmes require a multicomponent approach that includes addressing drug problems and mental health functioning. TRIAL REGISTRATION NUMBER: 12606000229572.

Survey methods and characteristics of a sample of Aboriginal and Torres Strait Islander and non-Indigenous people who have recently used methamphetamine: the NIMAC survey.

INTRODUCTION AND AIMS: There is a need for detailed information on methamphetamine use in Aboriginal and Torres Strait Islander communities. We describe a national survey on methamphetamine use among Aboriginal and Torres Strait Islander people and non-Indigenous people. DESIGN AND METHODS: Participants aged 16 years or older who reported using methamphetamine in the past year were recruited for a cross-sectional survey through 10 Aboriginal Community Controlled Organisations. Surveys were completed anonymously on electronic tablets. Measures included the Australian Treatment Outcomes Profile, the Severity of Dependence Scale, subscales from Opiate Treatment Index and the Kessler 10. A Chronic Stress Scale was used to assess culturally situated chronic stress factors. RESULTS: Of the 734 participants, 416 (59%) were Aboriginal or Torres Strait Islander and 331 (45%) were female. In the previous year, most participants reported smoking (48.7%) or injecting (34%) methamphetamine and 17.4% reported daily use. Aboriginal and Torres Strait Islander people did not differ significantly from non-Indigenous participants on methamphetamine use patterns (age at first use, frequency of use, main mode of use, injecting risk, poly drug use). Aboriginal and Torres Strait Islander participants felt less able to access health care (32% vs. 48%, P < 0.001), including mental health services (19% vs. 29%, P < 0.002), were less likely to report a mental health diagnosis (50% vs. 60%, P < 0.002) and were more likely to turn to family for support (52% vs. 34%, P < 0.001). DISCUSSION AND CONCLUSIONS: We recruited and surveyed a large sample of Aboriginal and Torres Strait Islander people from which we can derive detailed comparative data on methamphetamine use and related health service needs for Aboriginal and Torres Strait Islander and non-Indigenous Australians.

Fatherhood Following Treatment for Testicular Cancer: A Systematic Review and Meta-Analyses.

Purpose: Testicular cancer (TC) is considered the most commonly diagnosed malignancy in males between 15 and 34 years of age. The objective of this study is to systematically review and meta-analyze studies on fatherhood following treatment for TC. Methods: We reviewed studies reporting on fatherhood following TC from Medline and Embase search engines by developing search strategies. Only studies including patients with TC and at least one reproductive variable were considered as part of the analysis. Estimate of heterogeneity was calculated using the I2 statistic. Meta-analyses employing a fixed effects model were also applied as an additional measure of sensitivity. Results: A total of 27 studies were included which reported on fatherhood after treatment for TC. A meta-analysis of included studies with subgroup analysis was conducted. Subgroup analysis, for the combined studies, indicated an overall pooled pregnancy rate of 22% (95% confidence intervals [CI]: 0.21-0.23; I2 = 98.1%) for couples who conceived after TC. Of those couples that became pregnant, 11% (95% CI: 0.07-0.16; I2 = 8.5%) experienced a miscarriage. Fatherhood was experienced by 37% (95% CI: 0.35-0.39; I2 = 98.1%) of males following treatment for TC. Conclusions: Male cancer patients should be offered discussions, information, and counseling regarding the impact that TC treatment can have on fertility. Furthermore, sperm banking must be recommended to all patients before starting treatment.

Reproductive outcomes following a stem cell transplant for a haematological malignancy in female cancer survivors: a systematic review and meta-analysis.

PURPOSE: The use of high-dose chemotherapy and radiotherapy combined with haematopoietic stem cell transplantation (HSCT) may negatively affect a woman's reproductive potential. Reproductive outcomes such as infertility are a major concern for women who undergo treatment for a haematological cancer diagnosis. OBJECTIVE: This systematic review and meta-analysis explores reproductive outcomes following a haematological cancer requiring HSCT. METHODS: Electronic databases were searched to identify studies that reported on reproductive outcomes after treatment for a haematological cancer diagnosis. Studies were included that reported on pregnancy and reproductive outcomes following HSCT for a haematological malignancy. RESULTS: The meta-analysis included 14 studies, collectively involving 744 female patients. The subgroup analysis showed an overall pooled estimated pregnancy rate, for autologous or allogeneic HSCT recipients, of 22.7% (n = 438). There were 25% (n = 240) of women who became pregnant after autologous HSCT compared with 22% (n = 198) who subsequently became pregnant following allogeneic HSCT. CONCLUSIONS: This meta-analysis reflects low pregnancy rates for cancer survivors desiring a family. However, live births are improving over time with new technology and novel therapies. Hence, female cancer patients should be offered timely discussions, counselling and education around fertility preservation options prior to starting treatment with gonadotoxic therapy.

Reproductive outcomes following treatment for a gynecological cancer diagnosis: a systematic review.

PURPOSE: Fertility treatments are available for women diagnosed with a gynecological malignancy, which is important for women who desire a biological family subsequent to treatment. The objective of this study was to report reproductive outcomes following fertility-sparing treatment for a gynaecological cancer. METHODS: Electronic databases were searched to identify studies that reported on reproductive outcomes after treatment for a gynecological malignancy. RESULTS: In total, 77 studies were included which reported on reproductive outcomes after treatment for cervical cancer, endometrial cancer, gestational trophoblastic disease, and ovarian cancer. The main treatments included vaginal or abdominal radical trachelectomy, progestin therapy, salpingo-oophorectomy, and chemotherapy. The mean age at diagnosis for the study population and at birth were 30.5 years and 30.3 years, respectively. There were 4749 pregnancies (42%) reported for the included studies, with a miscarriage rate of 15% and a medical termination rate of 5%. The live birth rate was 74% with a 10% preterm rate. IMPLICATIONS FOR CANCER SURVIVORS: Patients should be offered timely discussions, information, and counseling regarding the impact of gynecological cancer treatment on a patient's fertility. Furthermore, fertility-sparing strategies and fertility preservation should be discussed prior to starting treatment.

Identifying missed clinical opportunities for the earlier diagnosis of HIV in Australia, a retrospective cohort data linkage study.

BACKGROUND: Treatment as prevention approaches for HIV require optimal HIV testing strategies to reduce undiagnosed HIV infections. In most settings, HIV testing strategies still result in unacceptably high rates of missed and late diagnoses. This study aimed to identify clinical opportunities for targeted HIV testing in persons at risk to facilitate earlier HIV diagnosis in New South Wales, Australia; and to assess the duration between the diagnosis of specific conditions and HIV diagnosis. METHODS: The Australian National HIV registry was linked to cancer diagnoses, notifiable condition diagnoses, emergency department presentations and hospital admissions for all HIV diagnoses between 1993 and 2012 in NSW. Date of HIV acquisition was estimated from back-projection models and people with a likely duration from infection to diagnosis of less than 180 days were excluded. Risk factors associated with clinical opportunities for the earlier diagnosis of HIV were identified. RESULTS: Sexually transmitted infection diagnoses (particularly gonorrhoea and syphilis) and some hospital admissions (mental health and drug-related diagnoses, and non-infective digestive disorder diagnoses) were prominent among people estimated to be living with undiagnosed HIV. The length of time between a clinical opportunity for the earlier HIV diagnosis and actual HIV diagnosis was 13.3 months for notifiable conditions, and 15.2 months for hospital admissions. People with lower CD4+ cell count at diagnosis, and older people were significantly less likely to have a missed opportunity for earlier HIV diagnosis. CONCLUSIONS: Additional targeted clinical HIV testing strategies are warranted for people with gonorrhoea and syphilis; and hospital presentations or admissions for mental health, drug-related and gastrointestinal diagnoses.

Reproductive Outcomes After a Childhood and Adolescent Young Adult Cancer Diagnosis in Female Cancer Survivors: A Systematic Review and Meta-analysis.

Improvements in cancer therapy for childhood and adolescent and young adult (AYA) survivors have increased in excess of 80% among pediatric patients and in excess of 85% among AYA cancer patients. Our research group explored the late effects consequences of cancer treatment on pregnancy and birth outcomes subsequent to a childhood (0-14 years) or AYA (15-25 years) diagnosis of cancer in female cancer survivors. Embase and Medline databases were searched. There were 17 review (n = 10 matched and n = 7 unmatched) studies that met the inclusion criteria. Subanalyses were conducted on 10 matched studies. The median age for all studies for patients at diagnosis and birth was 11 and 27 years, respectively. In matched cohort studies, female childhood and AYA cancer patients, who received chemotherapy alone, had a pooled estimated rate of 18% of experiencing a live birth compared with 10% of females who received radiotherapy alone and subsequently had a live birth. Females who received surgery alone reported higher pooled estimated rates of 44% for a live birth. For matched retrospective review studies, 79% (n = 973) of women experienced a live birth, of which 22% of these babies were born preterm. This meta-analysis found lower birth rates for survivors. Access to fertility-related information and discussions around fertility preservation options and oncofertility psychosocial support should be offered to all cancer patients and their families before starting cancer treatment.

Performance of clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal specimens, and visual inspection of the cervix with acetic acid, for the detection of underlying high-grade squamous intraepithelial lesions in Papua New Guinea.

The performance of different clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal ('V') specimens, and visual inspection of the cervix with acetic acid (VIA) was evaluated in Papua New Guinea. Women aged 30-59 years provided V specimens that were tested at point-of-care using the Xpert HPV Test (Cepheid, Sunnyvale, CA). A clinician-collected cervical ('C') specimen was then collected for point-of-care Xpert testing, and liquid-based cytology (LBC). Following this, VIA examination was conducted, blind to HPV test results, and ablative cervical cryotherapy provided if indicated. Detection of high-grade squamous intraepithelial lesion (HSIL) by LBC was the reference standard used to evaluate clinical screening algorithms. Of 1005 women, 36 had HSIL+. Xpert HPV Test performance using V specimens (sensitivity 91.7%, specificity 87.0%, PPV 34.0%, NPV 99.3%) was superior to VIA examination alone (51.5%, 81.4%, 17.5%, 95.6% respectively) in predicting underlying HSIL+. A screening algorithm comprising V specimen HPV testing followed by VIA examination had low sensitivity (45.5%) but comparable specificity, PPV and NPV to HPV testing alone (96.3%, 45.5%, 96.3% respectively). A 'test-and-treat' screening algorithm based on point-of-care HPV testing of V specimens had superior performance compared with either VIA examination alone, or a combined screening algorithm comprising HPV testing plus VIA.

Association between visual inspection of the cervix with acetic acid examination and high-risk human papillomavirus infection, Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in Papua New Guinea.

BACKGROUND: Papua New Guinea (PNG) has among the highest estimated burdens of cervical cancer globally but currently has no national cervical screening program. Visual inspection of the cervix with acetic acid (VIA) is a low-cost screening strategy endorsed by the World Health Organization that has been adopted in many low-resource settings but not previously evaluated in PNG. AIM: To evaluate the association between VIA examination findings and high-risk HPV (hrHPV) infection; and the impact of concomitant genital Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis on the interpretation of VIA findings. METHODS: A prospective clinical cohort study among women aged 30-59 years attending Well Woman Clinics in PNG. Main outcome measures were VIA examination findings and laboratory-confirmed hrHPV, C. trachomatis, N. gonorrhoeae and T. vaginalis. RESULTS: A total of 614 women were enrolled, of whom 87.5% (537/614) underwent VIA, and 12.5% (77/614) did not due to pre-existing cervicitis or inability to visualise the transformation zone. Among the 537 women who underwent VIA, 21.6% were VIA positive, 63.7% VIA negative, and 14.7% had indeterminate findings. The prevalence of hrHPV infection (n = 614) was 14.7%; C. trachomatis, 7.5%; N. gonorrhoeae, 8.0%; and T. vaginalis, 15.0%. VIA positive women were more likely to have HPV16 (odds ratio: 5.0; 95%CI: 1.6-15.6; P = 0.006) but there was no association between HPV18/45, all hrHPV types (combined), C. trachomatis, N. gonorrhoeae or T. vaginalis. CONCLUSIONS: VIA positivity was associated with HPV16, but not with other hrHPV infections, nor with genital C. trachomatis, N. gonorrhoeae or T. vaginalis in this setting.

Pregnancy Outcomes After a Breast Cancer Diagnosis: A Systematic Review and Meta-analysis.

Improvements in local and systemic treatment, along with earlier diagnoses through breast awareness and screening, have led to increases in survival and a decline in breast cancer (BC) recurrence. To the best of our knowledge, no meta-analysis has yet focused on pregnancy outcomes after BC treatment. Hence, our research group explored the reproductive outcomes (pregnancy, miscarriage, termination of pregnancy, live births) after BC treatment. The Embase, MEDLINE, PubMed, and Scopus databases were searched. Studies were included that reported on pregnancy and reproductive outcomes after treatment of BC. A meta-analysis of 16 studies with subgroup analyses was conducted. In the matched cohort and case-control studies (n = 1287), subgroup analysis showed that women who had received systemic therapy after surgery had an overall pooled estimate of 14% (95% confidence interval [CI], 0.12-0.16; I2 = 95.4%) of becoming pregnant. Of those who became pregnant, 12% (95% CI, 0.08-0.16; I2 = 65.9%) experienced a miscarriage. For the population-based studies (n = 711), the estimated pooled pregnancy rate was 3% (95% CI, 0.02-0.03; I2 = 85.1%) for women who became pregnant after BC treatment. The pregnancy rate after BC treatment for survivors was on average 40% lower than the general population pregnancy rate. Women with BC should be informed about the subsequent adverse effects of BC and its treatments on conception. With the increasing trend for women to defer childbirth to later in life, provision of fertility-related information, access to fertility preservation, and fertility-related psychosocial support should be offered to women of a reproductive age before they begin BC treatment.

Patient, staffing and health centre factors associated with annual testing for sexually transmissible infections in remote primary health centres.

BACKGROUND: In high-incidence Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) settings, annual re-testing is an important public health strategy. Using baseline laboratory data (2009-10) from a cluster randomised trial in 67 remote Aboriginal communities, the extent of re-testing was determined, along with the associated patient, staffing and health centre factors. METHODS: Annual testing was defined as re-testing in 9-15 months (guideline recommendation) and a broader time period of 5-15 months following an initial negative CT/NG test. Random effects logistic regression was used to determine factors associated with re-testing. RESULTS: Of 10559 individuals aged ≥16 years with an initial negative CT/NG test (median age=25 years), 20.3% had a re-test in 9-15 months (23.6% females vs 15.4% males, P<0.001) and 35.2% in 5-15 months (40.9% females vs 26.5% males, P<0.001). Factors independently associated with re-testing in 9-15 months in both males and females were: younger age (16-19, 20-24 years); and attending a centre that sees predominantly (>90%) Aboriginal people. Additional factors independently associated with re-testing for females were: being aged 25-29 years, attending a centre that used electronic medical records, and for males, attending a health centre that employed Aboriginal health workers and more male staff. CONCLUSIONS: Approximately 20% of people were re-tested within 9-15 months. Re-testing was more common in younger individuals. Findings highlight the importance of recall systems, Aboriginal health workers and male staff to facilitate annual re-testing. Further initiatives may be needed to increase re-testing.

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.

A Study Protocol for the Australasian Oncofertility Registry: Monitoring Referral Patterns and the Uptake, Quality, and Complications of Fertility Preservation Strategies in Australia and New Zealand.

Improvements in cancer diagnosis and treatment in patients of a reproductive age have led to significant improvements in survival rates; however, a patient's fertility can be affected by both cancer and its treatment. As survival rates improve, there is an expectation by clinicians and patients that patient's reproductive potential should be considered and protected as much as possible. However, there is a lack of data about current fertility preservation (FP) uptake as well as accurate data on the acute or permanent reproductive risks of cancer treatment, complications of FP in cancer patients, and the use and success of assisted reproductive technology by cancer survivors. FP remains a major gap in acute cancer management with lifelong implications for cancer survivors. The FUTuRE Fertility research team has established the first binational multisite Australasian Oncofertility Registry, which is collecting a complete oncofertility data set from cancer and fertility centers in Australia and New Zealand. Outcomes from the research study will monitor referral, uptake, and complications of FP, document patient's reproductive potential after treatment, and collect data on the use of assisted reproductive technology following cancer treatment. The data will be linked to other routine health and administrative data sets to allow for other research projects to be carried out. The changes in oncofertility care will be benchmarked against the Australasian Oncofertility Charter. The data will be used to develop evidence-based guidelines and resources, including development of accurate risk projections for patients' risk of infertility, allowing clinicians to make recommendations for FP or assisted reproductive technology. Australian New Zealand Clinical Trials Number-12615000221550.

Prevalence and Correlates of a Diagnosis of Sexually Transmitted Infection Among Young Aboriginal and Torres Strait Islander People: A National Survey.

BACKGROUND: Young Aboriginal and Torres Strait Islander (Aboriginal) people are recognized as a priority population for the control of sexually transmissible infections (STIs) in Australia. This article reports the prevalence of self-reported STI diagnoses and their correlates among Aboriginal people aged 16 to 29 years. METHODS: Results were analyzed from a survey conducted between 2011 and 2013 at regular community events. Univariate and multivariate logistic regression models were used to identify the correlates of a history of STI diagnosis among participants who reported being sexually active and ever having been tested for STIs. All analyses were stratified by sex. RESULTS: Of the 2877 participants in this study, 2320, comprising 60% females, self-reported ever having had vaginal or anal sex, and a further subset of 1589 (68%) reported ever being tested for any of the following STIs: chlamydia, gonorrhea, syphilis, or trichomonas. Within this latter group, the proportion who reported that they had had a positive STI diagnosis was 25%. In multivariate analysis, women who reported sexual debut before the age of 16 years (prevalence ratio [PR], 1.53; 95% confidence interval, 1.16-2.81; P < 0.05), ever having had oral sex (PR, 2.66; 1.47-4.82; P < 0.001), inconsistent condom use in the past 12 months (PR, 1.71; 1.13-2.58; P < 0.012), having had sex with someone they had just met (adjusted odds ratio, 1.74; 1.21-2.50; P < 0.003), and using ecstasy (PR, 1.81; 1.16-2.81; P < 0.009) were significantly associated with a self-reported history of an STI diagnosis. For men, being older (25-29 years; PR, 2.10; 1.10-3.96; P < 0.023), being gay or bisexual (PR, 2.22; 1.16-4.27; P < 0.016), not using a condom during last sex, (PR, 1.74; 1.10-2.76; P < 0.019), past ecstasy use (PR, 1.88; 1.11-3.20; P < 0.019), and injecting drug use (PR, 2.81; 1.35-5.88); P < 0.006) were independent predictors of ever reporting being diagnosed as having an STI. DISCUSSION: In the first community-based survey of this population, a self-reported history of ever being diagnosed as having prevalent STIs was common in sexually active young Aboriginal people who reported STI testing in the past. This population requires targeted education and health service interventions to address the high burden of STIs.

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.