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.

Autor: Herce ME; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia. michael.herce@cidrz.org.; Institute for Global Health and Infectious Diseases, University of North Carolina, Chapel Hill, NC, USA. michael.herce@cidrz.org., Bosomprah S; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana., Masiye F; Department of Health Economics, School of Public Health, University of Zambia, Ridgeway Campus, Lusaka, Zambia., Mweemba O; Department of Health Promotion and Education, School of Public Health, University of Zambia, Ridgeway Campus, Lusaka, Zambia., Edwards JK; Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA., Mandyata C; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Siame M; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Department of Paediatrics and Child Health, School of Medicine, University of Zambia, Lusaka, Zambia., Mwila C; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Matenga T; Department of Health Promotion and Education, School of Public Health, University of Zambia, Ridgeway Campus, Lusaka, Zambia., Frimpong C; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Mugala A; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Department of Medicine, Division of Infectious Diseases, University Teaching Hospital, Lusaka, Zambia., Mbewe P; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Shankalala P; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Sichone P; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Kasenge B; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Chunga L; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Adams R; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Banda B; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Mwamba D; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Nachalwe N; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Agarwal M; Institute of Public Health, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA., Williams MJ; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, U.S. National Institutes of Health, Bethesda, MD, USA., Tonwe V; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, U.S. National Institutes of Health, Bethesda, MD, USA., Pry JM; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Department of Epidemiology, School of Medicine, University of California at Davis, Davis, CA, USA., Musheke M; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Vinikoor M; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Division of Infectious Diseases, Department of Medicine, University of Alabama, Birmingham, AL, USA., Mutale W; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Department of Health Policy and Management, School of Public Health, University of Zambia, Lusaka, Zambia.
Jazyk: angličtina
Zdroj: Implementation science communications [Implement Sci Commun] 2024 Jun 06; Vol. 5 (1), pp. 61. Date of Electronic Publication: 2024 Jun 06.
DOI: 10.1186/s43058-024-00601-z
Abstrakt: 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).
(© 2024. The Author(s).)
Databáze: MEDLINE
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