Dataset Information

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

ABSTRACT: The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals.EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW.EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV epidemic.https://clinicaltrials.gov/ (identifying number NCT02870790 ; registration date 14 August 2016), pre-results stage.

SUBMITTER: Zablotska IB

PROVIDER: S-EPMC5797394 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

Zablotska Iryna B IB Selvey Christine C Guy Rebecca R Price Karen K Holden Jo J Schmidt Heather-Marie HM McNulty Anna A Smith David D Jin Fengyi F Amin Janaki J Cooper David A DA Grulich Andrew E AE

BMC public health 20180202 1

<h4>Background</h4>The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that ev ...[more]

PMID: 29394918

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Project description:INTRODUCTION:The World Health Organization, while recommending pre-exposure prophylaxis (PrEP) for HIV-negative pregnant and postpartum women in HIV high-burden settings, advocates for continued safety evaluation of PrEP in this population. METHODS:The PrEP Implementation in Young Women and Adolescents (PrIYA) program delivered PrEP to pregnant and postpartum women integrated within routine maternal and child health clinics (MCH) at 16 sites in Western Kenya. PrEP exposure and perinatal outcome data were collected among women obtaining postnatal services during programme evaluation. PrEP use was self-reported and confirmed with clinical records. Perinatal outcomes including gestational age at birth, birthweight, congenital malformations and infant growth outcomes were abstracted from clinical records for mother-infant pairs attending the six week visit. Associations between infant outcomes and maternal prenatal PrEP use were assessed using univariate and multivariate logistic and linear regression. RESULTS:The PrIYA evaluation identified 1530 postpartum mother-infant pairs with data on prenatal PrEP exposure: 206 with prenatal PrEP use, 1324 without. Median maternal age was 24 years in both groups. PrEP users (any reported PrEP use) were significantly more likely to report HIV risk factors such as: intimate partner violence, sexually transmitted infections and having a partner with positive or unknown HIV status. Most mothers initiated PrEP during the second trimester (n = 116, 57%) and used PrEP for more than one month (n = 110, 58%). The mean birthweight was 3.3 kg and gestational age at birth was 38.5 weeks in both groups. There were no major differences between PrEP exposed and unexposed infants in rates of preterm birth and low birthweight. There were no congenital malformations identified in the PrEP-exposed group and five reported in the PrEP unexposed group. At six weeks postpartum, infants in both groups had similar growth. No differences in infant outcomes were found by duration PrEP exposure, trimester of PrEP initiation, a subset analysis of women 15 to 24 years old or in multivariate analyses. This analysis demonstrates that monitoring of infant outcomes is feasible within large-scale programmatic implementation of PrEP among pregnant and postpartum populations. CONCLUSIONS:Pregnancy outcomes and early infant growth did not differ by PrEP exposure.

Project description:Lesbian, gay, bisexual, transgender and gender diverse people, and queer people (LGBTQ people) are at increased risk of some chronic diseases and cancers. NSW Health palliative care health policy prioritises equitable access to quality care, however, little is known about community members' perspectives on palliative care. This study aimed to understand LGBTQ community views and preferences in palliative care in NSW. A community survey and follow-up interviews with LGBTQ people in NSW were conducted in mid-2020. A total of 419 people responded to the survey, with 222 completing it. Six semi-structured phone interviews were conducted with participants who volunteered for follow-up. The sample included LGBTQ people with varied levels of experience in palliative care. Thematic analysis was conducted on survey and interview data, to identify perceived barriers and enablers, and situate these factors in the socio-ecological model of health. Some perceived barriers from community members related to considering whether to be 'out' (i.e., making one's sexual orientation and gender known to services), knowledge and attitudes of staff, concern about potential substandard care or mistreatment (particularly for transgender health), decision making, biological family as a source of tension, and loneliness and isolation. Perceived enablers related to developing and distributing inclusive palliative care information, engaging with community(ies), fostering inclusive and non-discriminatory service delivery, ensuring respectful approaches to person-centred care, and staff training on and awareness building of LGBTQ needs and issues. Most of the participants who had experienced palliative care recounted positive interactions, however, we identified that LGBTQ people require better access to knowledgeable and supportive services. Palliative care information should be inclusive and services respectful and welcoming. Particular consideration should be given to how services respond to and engage with people from diverse population groups. These insights can support ongoing policy and service development activities to further enhance palliative care.

Project description:Background: Outreach health practitioners play a key role in enhancing access to healthcare for remote, rural, regional, and Aboriginal and Torres Strait Islander communities in Australia. Outreach health practitioners are those providing ongoing and integrated health services in communities that would otherwise have limited access. In the context of the COVID-19 pandemic, it is important to understand the job satisfaction of health workers as it correlates with long-term retention of the workforce, as well as effectiveness in the role and clinical outcomes for patients. Method: The study analysed data from 258 outreach health practitioners who responded to two cross-sectional surveys conducted by the NSW Rural Doctors Network during the COVID-19 pandemic in 2020/21 and 2021/22 in NSW and the ACT, Australia. Both bivariate and multivariate analyses were employed to assess the associations between the outcome variable (outreach health practitioners' job satisfaction) and independent variables (sociodemographic factors, motivation, self-confidence, communication, capability). Results: Overall, the study showed that 92.2% of health practitioners were satisfied in their role providing outreach health services during the COVID-19 pandemic. In the multivariable model, factors significantly associated with higher satisfaction included good communication with other local health practitioners, using telehealth along with in-person care, and having high self-rated capability compared to those health practitioners who said they had lower job satisfaction. Conclusions: Outreach health practitioners' job satisfaction is important because poor satisfaction may lead to suboptimal healthcare delivery, poor clinical outcomes, and poor retention of staff in rural settings. These findings should be taken into consideration when developing future strategies to improve job satisfaction among rural outreach health practitioners and to enhance attraction, recruitment and retention and may be applicable to the broader health workforce.

Project description:BackgroundEndometriosis (where endometrial-like tissue is found outside the uterus) affects ~?176 million women worldwide and can lead to debilitating pelvic pain. There is an unmet need for new medical treatment options for endometriosis. Pelvic peritoneal mesothelial cells of women with endometriosis exhibit detrimental metabolic reprogramming that creates an environment favouring the formation and survival of endometriosis lesions. We have generated powerful preclinical proof-of-concept data to show that it is possible to correct this metabolic phenotype using dichloroacetate (DCA), a non-hormonal compound previously used to treat rare metabolic disorders in children. We plan a single-arm, open-label, single site exploratory clinical trial to inform the design of a future randomised controlled trial (RCT) to determine the efficacy of DCA for the treatment of endometriosis-associated pain.MethodsWe will recruit 30 women with endometriosis-associated pain over a 6-month period. All participants will receive approximately 6.25?mg/kg oral DCA capsules twice daily for 6?weeks, with a dose increase to approximately 12.5?mg/kg twice daily for a further 6?weeks if their pain has not been adequately controlled on this dose regime and side-effects are acceptable. If pain is adequately controlled with minimal side-effects, the lower dose will be continued for a further 6?weeks. The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within the defined exclusion and inclusion criteria. Secondary objectives are to determine the acceptability of the trial to participants, including the proposed methods of recruitment, treatment, follow-up frequency and number of questionnaires. The recruitment rate will be determined by the proportion of patients recruited from the pool of eligible women. The retention rate will be determined by the proportion of participants who attended the final trial visit.DiscussionThis is a feasibility study to explore effectiveness and acceptability of the proposed field methodology (recruitment, retention, study processes and compliance with treatment). The results will be used to inform the design of a future RCT.Trial registrationClinicalTrials.gov, NCT04046081 Registered 6 August 2019.

Dataset Information

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

Publications

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

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