Dataset Information

NZPrEP Demonstration Project: protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) to determine feasibility, acceptability, adverse and behavioural effects of PrEP provision to gay and bisexual men in publicly funded sexual health clinics in Auckland, New Zealand.

ABSTRACT: INTRODUCTION:New Zealand has experienced a rise in HIV diagnoses in recent years and new interventions are required to address this. METHODS AND ANALYSIS:NZPrEP (A demonstration project of HIV preexposure prophylaxis in Aotearoa New Zealand) is an open-label, single-arm treatment evaluation study to investigate feasibility, retention, adherence, and clinical and behavioural outcomes of HIV pre-exposure prophylaxis (PrEP) provision to gay and bisexual men (GBM) in a publicly funded secondary sexual health service in Auckland, New Zealand. The sample size is 150 GBM. Inclusion criteria were specific behavioural risk factors indicating an increased risk of HIV infection. Exclusion criteria were hepatitis B infection, any medical contraindications to prescribing tenofovir/emtricitabine or factors limiting ability to adhere to the study protocol. Eligible participants will be screened for HIV and other sexually transmissible infections (STIs) and for any medical contraindications to PrEP, and enrolled for a maximum follow-up period of 96 weeks. They will be required to attend for 3-monthly testing for HIV and STIs and monitoring for renal and liver toxicity. Participants will also be required to complete an online behavioural survey after each study visit. The outcomes of interest are feasibility of PrEP provision in a sexual health clinic setting, PrEP acceptability, and adverse medical and behavioural effects of PrEP. The study sample is limited to 150 participants due to funding and service constraints. Statistical analysis of all primary and secondary outcomes will be performed using Stata V.14 at the University of Auckland. Results for primary and secondary endpoints will be reported after the conclusion of the study in March 2019. ETHICS AND DISSEMINATION:The study was approved by the Health and Disability Ethics Committee on 15 September 2016 (16/NTA/112). Key findings will be submitted to peer-reviewed journals. A summary report will be circulated to the study and community stakeholders, and to the Auckland District Health Board, Ministry of Health and Pharmac. TRIAL REGISTRATION NUMBER:ACTRN12616001387415; Pre-results.

SUBMITTER: Azariah S

PROVIDER: S-EPMC6597636 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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NZPrEP Demonstration Project: protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) to determine feasibility, acceptability, adverse and behavioural effects of PrEP provision to gay and bisexual men in publicly funded sexual health clinics in Auckland, New Zealand.

Azariah Sunita S Saxton Peter P Franklin Richard R Forster Rose R Werder Suzanne S Jenkins Renee R

BMJ open 20190627 6

<h4>Introduction</h4>New Zealand has experienced a rise in HIV diagnoses in recent years and new interventions are required to address this.<h4>Methods and analysis</h4>NZPrEP (A demonstration project of HIV preexposure prophylaxis in Aotearoa New Zealand) is an open-label, single-arm treatment evaluation study to investigate feasibility, retention, adherence, and clinical and behavioural outcomes of HIV pre-exposure prophylaxis (PrEP) provision to gay and bisexual men (GBM) in a publicly funded ...[more]

PMID: 31248921

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Project description:BackgroundThere is little systematic assessment of how total health expenditure is distributed across diseases and comorbidities. The objective of this study was to use statistical methods to disaggregate all publicly funded health expenditure by disease and comorbidities in order to answer three research questions: (1) What is health expenditure by disease phase for noncommunicable diseases (NCDs) in New Zealand? (2) Is the cost of having two NCDs more or less than that expected given the independent costs of each NCD? (3) How is total health spending disaggregated by NCDs across age and by sex?Methods and findingsWe used linked data for all adult New Zealanders for publicly funded events, including hospitalisation, outpatient, pharmaceutical, laboratory testing, and primary care from 1 July 2007 to 30 June 2014. These data include 18.9 million person-years and $26.4 billion in spending (US$ 2016). We used case definition algorithms to identify if a person had any of six NCDs (cancer, cardiovascular disease [CVD], diabetes, musculoskeletal, neurological, and a chronic lung/liver/kidney [LLK] disease). Indicator variables were used to identify the presence of any of the 15 possible comorbidity pairings of these six NCDs. Regression was used to estimate excess annual health expenditure per person. Cause deletion methods were used to estimate total population expenditure by disease. A majority (59%) of health expenditure was attributable to NCDs. Expenditure due to diseases was generally highest in the year of diagnosis and year of death. A person having two diseases simultaneously generally had greater health expenditure than the expected sum of having the diseases separately, for all 15 comorbidity pairs except the CVD-cancer pair. For example, a 60-64-year-old female with none of the six NCDs had $633 per annum expenditure. If she had both CVD and chronic LLK, additional expenditure for CVD separately was $6,443/$839/$9,225 for the first year of diagnosis/prevalent years/last year of life if dying of CVD; additional expenditure for chronic LLK separately was $6,443/$1,291/$9,051; and the additional comorbidity expenditure of having both CVD and LLK was $2,456 (95% confidence interval [CI] $2,238-$2,674). The pattern was similar for males (e.g., additional comorbidity expenditure for a 60-64-year-old male with CVD and chronic LLK was $2,498 [95% CI $2,264-$2,632]). In addition to this, the excess comorbidity costs for a person with two diseases was greater at younger ages, e.g., excess expenditure for 45-49-year-old males with CVD and chronic LLK was 10 times higher than for 75-79-year-old males and six times higher for females. At the population level, 23.8% of total health expenditure was attributable to higher costs of having one of the 15 comorbidity pairs over and above the six NCDs separately; of the remaining expenditure, CVD accounted for 18.7%, followed by musculoskeletal (16.2%), neurological (14.4%), cancer (14.1%), chronic LLK disease (7.4%), and diabetes (5.5%). Major limitations included incomplete linkage to all costed events (although these were largely non-NCD events) and missing private expenditure.ConclusionsThe costs of having two NCDs simultaneously is typically superadditive, and more so for younger adults. Neurological and musculoskeletal diseases contributed the largest health system costs, in accord with burden of disease studies finding that they contribute large morbidity. Just as burden of disease methodology has advanced the understanding of disease burden, there is a need to create disease-based costing studies that facilitate the disaggregation of health budgets at a national level.

Project description:IntroductionHIV diagnoses among gay and bisexual men have increased over the past decade in Australia. HIV point-of-care testing (POCT) was introduced in Australia in 2011 as a strategy to increase HIV testing by making the testing process more convenient. We surveyed gay and bisexual men undergoing POCT to assess barriers to HIV testing and characteristics associated with not having previously tested for HIV (never testing).MethodsDuring 2011 and 2012, gay and bisexual men who were undergoing POCT at four Sydney sexual health clinics self-completed questionnaires assessing testing history and psychological and structural barriers to HIV testing. Bivariate and multivariate logistic regression was used to assess associations between patient characteristics and never testing.ResultsOf 1093 participants, 981 (89.9%) reported ever testing for HIV and 110 (10.1%) never testing. At least one barrier to testing was reported by 1046 men (95.7%), with only 47 men (4.3%) not reporting any barrier to testing. The most commonly reported barriers to testing were annoyance at having to return for results (30.2%), not having done anything risky (29.6%), stress in waiting for results (28.4%), being afraid of testing positive (27.5%) and having tested recently (23.2%). Never testing was independently associated with being non-gay-identified (adjusted odds ratio [AOR]: 1.9; 95% confidence interval [CI]: 1.1-3.2), being aged less than 25 years (AOR: 2.4; 95% CI: 1.6-3.8), living in a suburb with few gay couples (AOR: 1.9; 95% CI: 1.2-3.0), being afraid of testing HIV-positive (AOR: 1.6; 95% CI: 1.0-2.4), not knowing where to test (AOR: 3.8; 95% CI: 1.3-11.2) and reporting one or no sexual partners in the last six months (AOR: 2.7; 95% CI: 1.2-6.2).ConclusionsBarriers to HIV testing were commonly reported among the clinic-based gay and bisexual men in this study. Our findings suggest further health promotion and prevention strategies are needed to address the knowledge, attitudes and behavioural factors associated with never testing.

Dataset Information

NZPrEP Demonstration Project: protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) to determine feasibility, acceptability, adverse and behavioural effects of PrEP provision to gay and bisexual men in publicly funded sexual health clinics in Auckland, New Zealand.

Publications

NZPrEP Demonstration Project: protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) to determine feasibility, acceptability, adverse and behavioural effects of PrEP provision to gay and bisexual men in publicly funded sexual health clinics in Auckland, New Zealand.

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