Browsing by Author "Vinikoor, Michael"

Now showing 1 - 3 of 3

Evaluating a multifaceted implementation strategy and package of evidence-based interventions based on WHO PEN for people living with HIV and cardiometabolic conditions in Lusaka, Zambia: protocol for the TASKPEN hybrid effectiveness-implementation stepped wedge cluster randomized trial.
(2024-Jun-06) Herce, Michael E.; Bosomprah, Samuel; Masiye, Felix; Mweemba, Oliver; Edwards, Jessie K.; Mandyata, Chomba; Siame, Mmamulatelo ; Mwila, Chilambwe; Matenga, Tulani; Frimpong, Christiana ; Mugala, Anchindika; Mbewe, Peter; Shankalala, Perfect; Sichone, Pendasambo; Kasenge, Blessings; Chunga, Luanaledi ; Adams, Rupert; Banda, Brain; Mwamba, Daniel; Nachalwe, Namwinga; Agarwal, Mansi; Williams, Makeda J.; Tonwe, Veronica; Pry, Jake M.; Musheke, Maurice; Vinikoor, Michael; Mutale, Wilbroad
BACKGROUND: Despite increasing morbidity and mortality from non-communicable diseases (NCD) globally, health systems in low- and middle-income countries (LMICs) have limited capacity to address these chronic conditions, particularly in sub-Saharan Africa (SSA). There is an urgent need, therefore, to respond to NCDs in SSA, beginning by applying lessons learned from the first global response to any chronic disease-HIV-to tackle the leading cardiometabolic killers of people living with HIV (PLHIV). We have developed a feasible and acceptable package of evidence-based interventions and a multi-faceted implementation strategy, known as "TASKPEN," that has been adapted to the Zambian setting to address hypertension, diabetes, and dyslipidemia. The TASKPEN multifaceted implementation strategy focuses on reorganizing service delivery for integrated HIV-NCD care and features task-shifting, practice facilitation, and leveraging HIV platforms for NCD care. We propose a hybrid type II effectiveness-implementation stepped-wedge cluster randomized trial to evaluate the effects of TASKPEN on clinical and implementation outcomes, including dual control of HIV and cardiometabolic NCDs, as well as quality of life, intervention reach, and cost-effectiveness. METHODS: The trial will be conducted in 12 urban health facilities in Lusaka, Zambia over a 30-month period. Clinical outcomes will be assessed via surveys with PLHIV accessing routine HIV services, and a prospective cohort of PLHIV with cardiometabolic comorbidities nested within the larger trial. We will also collect data using mixed methods, including in-depth interviews, questionnaires, focus group discussions, and structured observations, and estimate cost-effectiveness through time-and-motion studies and other costing methods, to understand implementation outcomes according to Proctor's Outcomes for Implementation Research, the Consolidated Framework for Implementation Research, and selected dimensions of RE-AIM. DISCUSSION: Findings from this study will be used to make discrete, actionable, and context-specific recommendations in Zambia and the region for integrating cardiometabolic NCD care into national HIV treatment programs. While the TASKPEN study focuses on cardiometabolic NCDs in PLHIV, the multifaceted implementation strategy studied will be relevant to other NCDs and to people without HIV. It is expected that the trial will generate new insights that enable delivery of high-quality integrated HIV-NCD care, which may improve cardiovascular morbidity and viral suppression for PLHIV in SSA. This study was registered at ClinicalTrials.gov (NCT05950919).
Measuring alcohol consumption with biomarkers in intervention studies: A scoping review.
(2025-Aug-13) Kane, Jeremy C.; Chirayil, Priya; Pawar, Rhea; Inoue, Sachi; Hofer, Tamara; McDonell, Michael; Latkin, Carl; Chander, Geetanjali ; Martins, Silvia S.; Greene, Claire M.; Vinikoor, Michael; Sharma, Anjali; Hahn, Judith A.
In intervention studies, alcohol consumption is often measured by self-report alone, which can be impacted by social desirability, recall, and other biases. Biomarkers and biosensors have gained popularity as objective measurements of alcohol consumption that can improve the accuracy of results. This scoping review provides a narrative overview and describes the use of biomarkers in alcohol intervention studies to inform future research. We conducted a review of alcohol intervention literature including published studies and Clinicaltrials.gov registrations (2000-2021). Randomized controlled trials, quasi-experimental, and nonexperimental studies were included if they piloted or evaluated an intervention aimed at reducing unhealthy alcohol consumption and if an alcohol biomarker was used. Data charting included type of biomarker(s), the country and context of the study location, and a description of how the biomarker was used in analysis. We identified 168 alcohol intervention studies that included at least one biomarker. Blood alcohol content was the most used (N = 76). There was an upward trend in biomarker use over time; 24% of studies were published between 2000 and 2010, and 76% between 2011 and 2021. The use of direct biomarkers, phosphatidylethanol and ethyl glucuronide, and biosensors has increased in frequency over time relative to indirect biomarkers, such as aspartate aminotransferase, carbohydrate-deficient transferrin, and alanine aminotransferase. Most studies were conducted in high-income countries; only 15% were conducted in a low- or middle-income country. More than half of completed studies did not report on comparisons between self-report and biomarker results even when both were collected. Among studies that did report a comparison, 26% reported discordance between self-report and biomarker results. The use of direct biomarkers and biosensors is accelerating. There is a need for more consistency in reporting biomarker/self-report concordance results, more comparisons between multiple biomarkers, and for greater geographic representation within the alcohol biomarker literature.
Risk factors for impaired fasting glucose or diabetes among HIV infected patients on ART in the Copperbelt Province of Zambia.
(2017) Shankalala, Perfect; Jacobs, Choolwe; Bosomprah, Samuel; Vinikoor, Michael; Katayamoyo, Patrick; Michelo, Charles
BACKGROUND: Africa has a high prevalence of both Human Immunodeficiency Virus and Non Communicable Diseases (NCDs) but in Zambia there are few data on co-morbid NCDs like Diabetes Mellitus (DM) among HIV-infected individuals. We aimed to identify risk factors for impaired fasting glucose or diabetes among HIV-infected Zambians on long-term Combined Antiretroviral Treatment (cART). METHODS: This was a cross sectional study of adult HIV patients in five health facilities of Copperbelt Province in Zambia. HIV/AIDS patients aged 18 years and above, enrolled in care at those health facilities and had been on cART for more than 2 years were included. All patients known to have Diabetes mellitus were excluded from the study. Participants underwent assessment of random blood sugar levels at enrolment and returned the following morning for fasting glucose measured by glucometers. The primary outcome was proportion with impaired fasting glucose or DM. Multivariable logistic regression was used to examine if demographics, time on ART, type of ART regimen, body mass index and baseline CD4 count were predictors of impaired fasting glucose. RESULTS: Overall ( CONCLUSION: We have found high levels of impaired fasting glucose or diabetes among ART patients compared to what is reported in the general population suggesting missed care and support opportunities associated with metabolic imbalance management. There is thus a need to re-package HIV programming to include integration of diabetes screening as part of the overall care and support strategy.