Background: Persistent immune activation and inflammation in HIV-infection are linked to excess cardiovascular risk and other non-communicable diseases. Periodic asymptomatic CMV-reactivity in HIV infected patients over a lifetime may contribute to non-AIDS defining morbidity. Despite undetectable levels of HIV and CMV, these patients continue to have increased levels of biomarkers and immune activations. Statin administration is thought to reduce subclinical atherosclerosis by decreasing LDL-C levels. It may also add beneficial effects against CMV infection. Methods: We are conducting a double-blind placebo-controlled trial in which patients are randomized to receive either atorvastatin or placebo with a ratio of 1:1. This trial aims to study the effect of atorvastatin in statin-naive virally-suppressed HIV-infected patients with stable ART and CMV seropositivity on carotid intima media thickness (CIMT), tool that evaluates subclinical atherosclerosis. The study recruits 80 patients at HIV integrated care unit of Cipto Mangunkusumo hospital. All eligible subjects have CIMT evaluation as primary outcome, along with flow mediated vasodilatation (FMD), liver fibrosis and steatosis evaluation, fasting lipid, neurocognitive test, community periodontal index (CPI), and residual immune activation as secondary outcomes in 48 weeks. Ethics and dissemination: This study has received an ethical approval from Health Research Ethics Commitee–Universitas Indonesia and Cipto Mangunkusumo Hospital. Before joining the study, all participants fill in an informed consent form. At the end of study analysis, the trial results will be published and disseminated in peer-reviewed journals. Discussion: The main purpose of our study is to evaluate the effect of atorvastatin administration on CIMT changes in statin naïve virally suppressed HIV-infected patients with stable ART and CMV seropositivity Registration: ClinicalTrials.gov ID NCT04101136; registered on 24 September 2019.
Introduction COVID -19 pandemic has threatened the optimal achievement on type-2 diabetes mellitus (T2DM) target in primary health care (PHC), due to our priority in COVID-19 management, limited access of patients to PHC and their lifestyle changes as the impact of social restrictions. Therefore, the empowerment of capability of patients on diabetes self-care is required through optimal education and support. The use of telehealth in T2DM management has benefits on improving outcomes of patients. We aim to assess the role of telehealth diabetes self-management education (DSME) versus hybrid (telehealth and face-to-face method) diabetes self-management education and support (DSMES) to improve T2DM outcomes in PHC during COVID-19 pandemic. Methods and analysis This study is an open label randomized-controlled trial that will be conducted in 10 PHCs in Jakarta, Indonesia, involving patients with T2DM. Subjects are classified into 2 groups: DSME group and DSMES group. Intervention will be given every 2 weeks. DSME group will receive 1 educational video every 2 weeks discussing topics about diabetes self-management, while DSMES group will receive 1 educational video and undergo 1 coaching session every 2 weeks. All interventions will be conducted by trained health workers of PHC, who are physicians, nurses, and nutritionists. Our primary outcome is the change of HbA1C level and our secondary outcomes are the changes of nutritional intake, physical activity, quality of life, anthropometric parameter, fasting blood glucose, lipid profile, inflammatory markers, and progression of diabetes complications at 3 and 6 months after intervention compare to the baseline. Ethics and dissemination This study protocol has been approved by the Health Research Ethics Committee University of Indonesia. Subjects agree to participate will be given written informed consent prior to data collection. Findings from this study will be published in peer-reviewed journals and presented at conferences. Trial Registration http://www.clinicalstrials.gov with identifier numberNCT05090488.
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