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
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Published:2024-06-06
Issue:1
Volume:5
Page:
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ISSN:2662-2211
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Container-title:Implementation Science Communications
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language:en
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Short-container-title:Implement Sci Commun
Author:
Herce Michael E.ORCID, 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 Brian, Mwamba Daniel, Nachalwe Namwinga, Agarwal Mansi, Williams Makeda J., Tonwe Veronica, Pry Jake M., Musheke Maurice, Vinikoor Michael, Mutale Wilbroad
Abstract
Abstract
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).
Funder
National Heart, Lung, and Blood Institute
Publisher
Springer Science and Business Media LLC
Reference54 articles.
1. WHO. Preventing chronic disease: A vital investment. Geneva: World Health Organization; 2005. 2. WHO. Non-communicable diseases Fact Sheet: World Health Organization (WHO); 2023. Available from: https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases. 3. Levitt NS, Steyn K, Dave J, Bradshaw D. Chronic noncommunicable diseases and HIV-AIDS on a collision course: relevance for health care delivery, particularly in low-resource settings–insights from South Africa. Am J Clin Nutr. 2011;94(6):1690S-S1696. 4. Mukanu MM, Zulu JM, Mweemba C, Mutale W. Responding to non-communicable diseases in Zambia: a policy analysis. Health Res Policy Syst. 2017;15(1):34. 5. Mutale W, Bosomprah S, Shankalala P, Mweemba O, Chilengi R, Kapambwe S, et al. Assessing capacity and readiness to manage NCDs in primary care setting: Gaps and opportunities based on adapted WHO PEN tool in Zambia. PLoS ONE. 2018;13(8): e0200994.
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