Integrating hypertension detection and management in HIV care in South Africa: protocol for a stepped-wedged cluster randomized effectiveness-implementation hybrid trial.

Autor: Galaviz KI; Indiana University School of Public Health Bloomington , #1025 E 7th St, Bloomington, IN, 47405, USA. kgalaviz@iu.edu., Patel SA; Hubert Department of Global Health, Emory University, Atlanta, GA, USA.; Emory Global Diabetes Research Center of the Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA., Siedner MJ; Africa Health Research Institute, KwaZulu-Natal, South Africa.; Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA., Goss CW; Washington University School of Medicine in St. Louis, St. Louis, MO, USA., Gumede SB; Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Johnson LC; Department of Family and Preventive Medicine, School of Medicine, Emory University, Atlanta, GA, USA., Ordóñez CE; Hubert Department of Global Health, Emory University, Atlanta, GA, USA., Laxy M; School of Medicine and Health, Technical University of Munich, Munich, Germany., Klipstein-Grobusch K; Department of Global Public Health and Bioethics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.; Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Heine M; Department of Global Public Health and Bioethics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.; Institute of Sport and Exercise Medicine, Department of Exercise, Sport and Lifestyle Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa., Masterson M; National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA., Mody A; Washington University School of Medicine in St. Louis, St. Louis, MO, USA., Venter WDF; Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Marconi VC; Hubert Department of Global Health, Emory University, Atlanta, GA, USA.; Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, USA., Ali MK; Hubert Department of Global Health, Emory University, Atlanta, GA, USA.; Emory Global Diabetes Research Center of the Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA.; Department of Family and Preventive Medicine, School of Medicine, Emory University, Atlanta, GA, USA., Lalla-Edward ST; Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Jazyk: angličtina
Zdroj: Implementation science communications [Implement Sci Commun] 2024 Oct 14; Vol. 5 (1), pp. 115. Date of Electronic Publication: 2024 Oct 14.
DOI: 10.1186/s43058-024-00640-6
Abstrakt: Background: HIV clinical guidelines recommend hypertension detection and management to lower cardiovascular disease risk, but these have not been effectively implemented for people living with HIV (PWH). Addressing this implementation gap requires community-engaged implementation studies focused on addressing implementation barriers specific to the HIV care context.
Methods: This protocol describes a type 2 effectiveness-implementation hybrid study conducted in nine primary care clinics in Johannesburg. The study will evaluate the effect of implementation strategies on guideline-recommended blood pressure assessment and management in HIV clinics and the effects of assessment/management on patient blood pressure. A stepped-wedge, cluster randomized study design was used to randomize clinics to the time at which they receive the implementation strategies and patient intervention. The implementation strategies tested include identifying and preparing care champions, changing record systems, conducting ongoing training, providing audit and feedback, and changing the physical structure/equipment. The patient intervention tested includes detection of elevated blood pressure, educational materials, lifestyle modification advice, and medication where needed. Implementation outcomes include adoption, fidelity (co-primary outcome), cost, and maintenance of the blood pressure assessment protocol in participating clinics, while patient outcomes include reach, effectiveness (co-primary outcome), and long-term effects of the intervention on patient blood pressure. These will be assessed via direct observation, study records, staff logs, medical chart reviews, and patient and healthcare worker surveys. To examine effects on the implementation (intervention fidelity) and effectiveness (patient blood pressure changes) co-primary outcomes, we will use the standard Hussey and Hughes model for analysis of stepped-wedge designs which includes fixed effects for both interventions and time periods, and a random effect for sites. Finally, we will examine the costs for the implementation strategies, healthcare worker time, and patient-facing intervention materials, as well as the cost-effectiveness and cost-utility of the intervention using study records, patient surveys, and a time and motion assessment.
Discussion: This study will address knowledge gaps around implementation of cardiovascular disease preventive practices in HIV care in South Africa. In doing so, it will provide a dual opportunity to promote evidence-based care in the South African HIV care context and help refine implementation research methods to better serve HIV populations globally.
Trial Registration: ClinicalTrials.gov: NCT05846503. Registered on May 6, 2023. https://classic.
Clinicaltrials: gov/ct2/show/NCT05846503 .
(© 2024. The Author(s).)
Databáze: MEDLINE
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