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Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

ABSTRACT: A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the World Health Organization for persons at high risk of acquiring HIV, but not all countries immediately adopted those recommendations. The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to SoC and PrEP in HIV prevention clinical trials taking place in lower- to middle-income countries (LMIC). Policymakers, regulators, ethicists, experts in law, researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. A group of subject matter experts presented on the regulatory, ethical, scientific, and historic framework of SoC in clinical trials, focusing on PrEP in South Africa. Summit participants discussed how and when to include new HIV treatment and prevention practices into existing clinical guidelines and trial protocols, as well as the opportunities for and challenges to scaling up interventions. The summit addressed challenges to PrEP provision, such as inconsistent efficacy amongst different populations and various biological, virological, and immunological explanations for this heterogeneity. Advocates and community members propagated the urgent need for accessible interventions that could avert HIV infection. The meeting recommended supporting access to PrEP in HIV prevention trials by (1) developing PrEP access plans for HIV vaccine trials, (2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism, and (3) supporting the safety monitoring of PrEP. This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05754-z.

SUBMITTER: Miner M

PROVIDER: S-EPMC8572437 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCommunity Engagement is an important ethical imperative in research. Although substantial research emphasizes its real value and strategic importance, much of the available literature focuses primarily on the success of community participation, with little emphasis given to specific community engagement processes, mechanisms and strategies in relation to intended outcomes in research environments. The systematic literature review's objective was to explore the nature of community engagement processes, strategies and approaches in health research settings in low- and middle-income countries.MethodsThe systematic literature review design was informed by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched for peer-reviewed, English-language literature published between January 2011 and December 2021 through three databases on the internet (PubMed, Web of Science and Google Scholar). The terms "community engagement," "community involvement," "participation," "research settings," and "low- and middle-income countries" were merged in the search.ResultsThe majority of publications [8/10] were led by authors from low- and middle-income countries, with many of them, [9/10] failing to continuously include important aspects of study quality. Even though consultation and information sessions were less participatory, articles were most likely to describe community engagement in these types of events. The articles covered a wide range of health issues, but the majority were concerned with infectious diseases such as malaria, human immunodeficiency virus, and tuberculosis, followed by studies on the environment and broader health factors. Articles were largely under-theorized.ConclusionsDespite the lack of theoretical underpinnings for various community engagement processes, strategies and approaches, community engagement in research settings was variable. Future studies should go deeper into community engagement theory, acknowledge the power dynamics underpin community engagement, and be more practical about the extent to which communities may participate.

Project description:In low- and middle-income countries (LMIC) in Asia, pharmacies are often patients' first point of contact with the health care system and their preferred channel for purchasing medicines. Unfortunately, pharmacy practice in these settings has been characterized by deficient knowledge and inappropriate treatment. This paper systematically reviews both the performance of all types of pharmacies and drug stores across Asia's LMIC, and the determinants of poor practice, in order to reflect on how this could best be addressed. Poor pharmacy practice in Asia appears to have persisted over the past 30 years. We identify a set of inadequacies that occur at key moments throughout the pharmacy encounter, including: insufficient history taking; lack of referral of patients who require medical attention; illegal sale of a wide range of prescription only medicines without a prescription; sale of medicines that are either clinically inappropriate and/or in doses that are outside of the therapeutic range; sale of incomplete courses of antibiotics; and limited provision of information and counselling. In terms of determinants of poor practice, first knowledge was found to be necessary but not sufficient to ensure correct management of patients presenting at the pharmacy. This is evidenced by large discrepancies between stated and actual practice; little difference in the treatment behaviour of less and more qualified personnel and the failure of training programmes to improve practice to a satisfactory level. Second, we identified a number of profit maximizing strategies employed by pharmacy staff that can be linked to poor practices. Finally, whilst the research is relatively sparse, the regulatory environment appears to play an important role in shaping behaviour. Future efforts to improve the situation may yield more success than historical attempts, which have tended to concentrate on education, if they address the profit incentives faced by pharmacy personnel and the regulatory system.

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Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

Supplementary Information

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