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1.  STI in remote communities: improved and enhanced primary health care (STRIVE) study protocol: a cluster randomised controlled trial comparing ‘usual practice’ STI care to enhanced care in remote primary health care services in Australia 
BMC Infectious Diseases  2013;13:425.
Despite two decades of interventions, rates of sexually transmissible infections (STI) in remote Australian Aboriginal communities remain unacceptably high. Routine notifications data from 2011 indicate rates of chlamydia and gonorrhoea among Aboriginal people in remote settings were 8 and 61 times higher respectively than in the non-Indigenous population.
STRIVE is a stepped-wedge cluster randomised trial designed to compare a sexual health quality improvement program (SHQIP) to usual STI clinical care delivered in remote primary health care services. The SHQIP is a multifaceted intervention comprising annual assessments of sexual health service delivery, implementation of a sexual health action plan, six-monthly clinical service activity data reports, regular feedback meetings with a regional coordinator, training and financial incentive payments. The trial clusters comprise either a single community or several communities grouped together based on geographic proximity and cultural ties. The primary outcomes are: prevalence of chlamydia, gonorrhoea and trichomonas in Aboriginal residents aged 16–34 years, and performance in clinical management of STIs based on best practice indicators. STRIVE will be conducted over five years comprising one and a half years of trial initiation and community consultation, three years of trial conditions, and a half year of data analysis. The trial was initiated in 68 remote Aboriginal health services in the Northern Territory, Queensland and Western Australia.
STRIVE is the first cluster randomised trial in STI care in remote Aboriginal health services. The trial will provide evidence to inform future culturally appropriate STI clinical care and control strategies in communities with high STI rates.
Trial registration
Australian and New Zealand Clinical Trials Registry ACTRN12610000358044
PMCID: PMC3847940  PMID: 24016143
Aboriginal; Indigenous; Sexually transmitted infections; Chlamydia; Gonorrhoea; Trichomonas; Continuous quality improvement; Protocol; Prevalence; Remote
2.  Improving Adherence to Guidelines for the Diagnosis and Management of Pelvic Inflammatory Disease: A Systematic Review 
Background. Evidence suggests adherence to clinical guidelines for pelvic inflammatory disease (PID) diagnosis and management is suboptimal. We systematically reviewed the literature for studies describing strategies to improve the adherence to PID clinical guidelines. Methods. The databases MEDLINE and EMBASE, and reference lists of review articles were searched from January 2000 to April 2012. Only studies with a control group were included. Results. An interrupted time-series study and two randomised controlled trials (RCTs) were included. The interrupted time-series found that following a multifaceted patient and practitioner intervention (practice protocol, provision of antibiotics on-site, written instructions for patients, and active followup), more patients received the recommended antibiotics and attended for followup. One RCT found a patient video on PID self-care did not improve medication compliance and followup. Another RCT found an abbreviated PID treatment guideline for health-practitioners improved their management of PID in hypothetical case scenarios but not their diagnosis of PID. Conclusion. There is limited research on what strategies can improve practitioner and patient adherence to PID diagnosis and management guidelines. Interventions that make managing PID more convenient, such as summary guidelines and provision of treatment on-site, appear to lead to better adherence but further empirical evidence is necessary.
PMCID: PMC3437626  PMID: 22973085
3.  A Microsphere-Based Vaccine Prevents and Reverses New-Onset Autoimmune Diabetes 
Diabetes  2008;57(6):1544-1555.
This study was aimed at ascertaining the efficacy of antisense oligonucleotide-formulated microspheres to prevent type 1 diabetes and to reverse new-onset disease.
Microspheres carrying antisense oligonucleotides to CD40, CD80, and CD86 were delivered into NOD mice. Glycemia was monitored to determine disease prevention and reversal. In recipients that remained and/or became diabetes free, spleen and lymph node T-cells were enriched to determine the prevalence of Foxp3+ putative regulatory T-cells (Treg cells). Splenocytes from diabetes-free microsphere-treated recipients were adoptively cotransferred with splenocytes from diabetic NOD mice into NOD-scid recipients. Live animal in vivo imaging measured the microsphere accumulation pattern. To rule out nonspecific systemic immunosuppression, splenocytes from successfully treated recipients were pulsed with β-cell antigen or ovalbumin or cocultured with allogeneic splenocytes.
The microspheres prevented type 1 diabetes and, most importantly, exhibited a capacity to reverse clinical hyperglycemia, suggesting reversal of new-onset disease. The microspheres augmented Foxp3+ Treg cells and induced hyporesponsiveness to NOD-derived pancreatic β-cell antigen, without compromising global immune responses to alloantigens and nominal antigens. T-cells from successfully treated mice suppressed adoptive transfer of disease by diabetogenic splenocytes into secondary immunodeficient recipients. Finally, microspheres accumulated within the pancreas and the spleen after either intraperitoneal or subcutaneous injection. Dendritic cells from spleen of the microsphere-treated mice exhibit decreased cell surface CD40, CD80, and CD86.
This novel microsphere formulation represents the first diabetes-suppressive and reversing nucleic acid vaccine that confers an immunoregulatory phenotype to endogenous dendritic cells.
PMCID: PMC2713034  PMID: 18316361

Results 1-3 (3)