Expanding Access to HIV Viral Load Testing: A Systematic Review of RNA Stability in EDTA Tubes and PPT beyond Current Time and Temperature Thresholds

Background: HIV viral load (VL) testing is the gold standard for antiretroviral treatment monitoring, but many barriers exist to VL testing in resource-limited settings, including storage and transport limitations for whole blood and plasma. Data from various studies indicate that HIV RNA is stable beyond current recommendations. We conducted a systematic review to assess stability data of HIV RNA in whole blood and plasma across times and temperatures. Methods and Findings: Using a pre-defined protocol, five databases were searched for studies where blood samples from HIV patients were stored at time and temperature points that exceeded manufacturer recommendations. RNA stability, the primary outcome, was measured by the difference in means compared to samples stored within established thresholds. RNA stability was defined as ≤0.5 log degradation. The search identified 10,716 titles, of which nine full-text articles were included for review. HIV RNA maintained stability in EDTA whole blood and plasma at all measured time points up to 168 hours when stored at 4°C, while stability was detected at 72 hours (95% confidence) in whole blood at 25°C, with data points before and beyond 72 hours suggesting stability but not reaching statistical significance. For EDTA plasma stored at 30°C, stability was maintained up to 48 hours (95% confidence), with OLS linear regression estimates up to 127 hours, suggesting stability. Overall, quality of studies was moderate. Limitations included small sample sizes, few studies meeting inclusion criteria, and no studies examining RNA stability in low viremia (<3,000 copies/mL) environments. Conclusions: Whole blood and plasma samples in EDTA may remain stable under conditions exceeding current manufacturer recommendations for HIV VL testing. However, given the limited number of studies addressing this question, especially at low levels of viremia, additional evaluations on HIV RNA stability in EDTA tubes and PPT in field conditions are needed

Protocol for a randomised controlled trial evaluating the effects of providing essential medicines at no charge: the Carefully seLected and Easily Accessible at No Charge Medicines (CLEAN Meds) trial

Introduction: Cost-related non-adherence to medicines is common in low-income, middle-income and high-income countries such as Canada. Medicine non-adherence is associated with poor health outcomes and increased mortality. This randomised trial will test the impact of a carefully selected list of essential medicines at no charge (compared with usual medicine access) in primary care patients reporting cost-related non-adherence. Methods and analysis This is an open-label, parallel two-arm, superiority, individually randomised controlled trial conducted in three primary care sites (one urban, two rural) in Ontario, Canada, that was codesigned by a community guidance panel. Adult patients (≥18 years) who report cost-related non-adherence to medicines are eligible to participate in the study. Participants will be randomised to receive free and convenient access to a carefully selected list of 125 essential medicines (based on the WHO’s Model List of Essential Medicines) or usual means of medicine access. Care for patients in both groups will otherwise be unchanged. The primary outcome of this trial is adherence to appropriately prescribed medicines. Secondary outcomes include medicine adherence, appropriate prescribing, blood pressure, haemoglobin A1c, low-density lipoprotein cholesterol, patient-oriented outcomes and healthcare costs. All participants will be followed for at least 12 months. Ethics and dissemination Ethics approval was obtained in all three participating sites. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal and discussed with members of the public and decision makers. Trial registration number NCT02744963

Effect on treatment adherence of distributing essential medicines at no charge : the CLEAN Meds randomized clinical trial

This work is supported by grant 381409 from the Canadian Institutes for Health Research, the Ontario SPOR Support Unit that is supported by the Canadian Institutes of Health Research and the Province of Ontario, the Canada Research Chairs program, and the St Michael’s Hospital Foundation.Importance: Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients. Objective: To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence. Design, Setting, and Participants: A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor-blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle. Interventions: Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391). Main Outcomes and Measures: The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines. Results: Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A1c, -0.38%; 95% CI, -0.76% to 0.00%), systolic blood pressure was reduced (-7.2 mm Hg; 95% CI, -11.7 to -2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (-2.3 mg/dL; 95% CI, -14.7 to 10.0 mg/dL). Conclusions and Relevance: The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines. Trial Registration: ClinicalTrials.gov identifier: NCT02744963.Publisher PDFPeer reviewe

Institute of Social Justice and Medicine: Developing a think tank to promote policy formation

The World Health Organization (WHO) defines health as a “resource for everyday living, not the objective of living”; however, worldwide, there remains an unmistakable inequity in level of health and access to healthcare. The WHO has published documents on financing health systems towards universal health coverage [1], promoting healthy life [2], improving performance of health systems [3], and enriching humanity [4], highlighting our shared responsibility towards improving both national and global health and access to healthcare. These documents also recognize that, despite our local and regional priorities, there is a global desire to develop international strategies to improve healthcare. [1] WHO Report. Health systems financing and the path to universal coverage. 2010. http://www.who.int/bulletin/health_financing/en/index.html [2] WHO Report. Reducing risks, promoting healthy life. 2002. http://www.who.int/whr/2002/en/index.html [3] WHO Bulletin. Health systems: improving performance. 2000. http://www.who.int/whr/2000/en/index.html [4] WHO Bulletin. Conquering suffering, enriching humanity 1997. http://www.who.int/whr/1997/en/index.htm

Political and Policy Arguments for Integrated Data

ABSTRACT Introduction There is little argument that integrated data can provide a valuable resource for improved health system management, planning, and accountability as well as discovery and commercial use, but policies to enable and support integrated data fall short of the potential represented by integrated data. To understand the current level of progress on policy for integrated data, we looked at two successful and two unsuccessful efforts to support the creation and use of integrated data in health systems. Methods/Approach We used document and literature analysis to develop descriptions of the Icelandic Health Sector Database Act, the creation of the Institute for Clinical Evaluative Sciences in Ontario (Canada), the care.data initiative in the United Kingdom, and the Health Datapalooza initiative in the US and used an Ideas, Institutions and Actors framework to compare the experience with integrated data policy and politics. Results and discussion Our analysis suggests that institutions around integrated data remain under-developed and largely focused on specific aspects of integrated data policy or use. There are at least two sets of dominant ideas around integrated data – data as a tool for economic development and health system performance and data as a threat to privacy and liberty – that are often diametrically opposed in different jurisdictions. To a great extent, powerful actors remain disengaged from integrated data discussions and leadership engaged in integrated data policy and politics remains isolated from larger policy and political discussions. The medical profession along with civil society groups can mount effective opposition to integrated data initiatives, although potentially for different reasons (accountability and privacy concerns respectively). Conclusions Our analysis suggests several key issues around successful integrated data policy and politics that support the importance of strong leadership, an incremental approach to institution building that focuses on public benefits, strongly alignment to missions that are congruent with societal values, and stronger attention to effective and rapid implementation of policy. In addition to the cases studied here, the success of smaller sub-national (e.g. state or provincial) efforts suggests that smaller efforts tend to work better although their success may not receive the attention that could support larger efforts to integrate data on the national level. Further work should focus chiefly on the extension of these arguments to non-health sectors to realize the full value of integrated data

RNA degradation in EDTA tubes over time and temperature.

<p>RNA degradation in EDTA tubes over time and temperature.</p

Characteristics of included studies.

<p>ART, antiretroviral therapy; PPT, plasma preparation tube; EDTA,; rho, spearman’s rank correlation coefficient.</p><p>* Note: there was no trend towards more variation among lower viral loads (data not specified).</p><p>Characteristics of included studies.</p

Search Strategy.

<p>Search Strategy.</p