Abstract
Background
Despite success in HIV treatment, diagnosis and management of hypertension (HTN) and cardiovascular disease (CVD) remains suboptimal among people living with HIV (PLWH) in Botswana, with an overall HTN control of only 19% compared to 98% HIV viral suppressed. These gaps persist despite CVD primary care national guidelines and availability of free healthcare including antihypertensive medications. Our study aims to develop and test strategies to close the HTN care gap in PLWH, through integration into HIV care, leveraging the successful national HIV care and treatment program and strategies.
Methods
The InterCARE trial is a cluster randomized controlled hybrid type 2 effectiveness-implementation trial at 14 sites designed to enroll 4652 adults living with HIV and HTN plus up to 2326 treatment partners. Primary outcomes included effectiveness (HTN control) and implementation outcomes using the Reach Effectiveness Adoption Implementation and Maintenance framework, with explanatory mixed methods used to understand variability in outcomes.
InterCARE trial’s main strategies include healthcare worker HTN and CVD care training plus long-term practice facilitation, electronic health record (EHR) documentation of key indicators and use of reminders, and use of treatment partners to provide social support to people living with HIV and HTN. InterCARE started with formative research to identify contextual factors influencing care gaps using the Consolidated Framework for Implementation Research. Results were used to adapt initial and develop additional implementation strategies to address barriers and leverage facilitators. The package was pilot tested in two clinics, with findings used to further adapt or add strategies for the clinical trial.
Discussion
If successful, the InterCARE model can be scaled up to HIV clinics nationwide to improve diagnosis, management, and support in Botswana. The trial will provide insights for scale-up of HTN integration into HIV care in the region.
Trial registration
ClinicalTrials.gov reference NCT05414526. Registered 18 May 2022, https://clinicaltrials.gov/study/NCT05414526?term=NCT05414526.&rank=1.
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Details
1 London School of Hygiene and Tropical Medicine, London, UK (GRID:grid.8991.9) (ISNI:0000 0004 0425 469X); Botswana Harvard Health Partnership, Gaborone, Botswana (GRID:grid.8991.9)
2 University of Botswana, Faculty of Medicine, Gaborone, Botswana (GRID:grid.7621.2) (ISNI:0000 0004 0635 5486)
3 Botswana Harvard Health Partnership, Gaborone, Botswana (GRID:grid.7621.2); University of Botswana, Faculty of Medicine, Gaborone, Botswana (GRID:grid.7621.2) (ISNI:0000 0004 0635 5486)
4 Botswana Harvard Health Partnership, Gaborone, Botswana (GRID:grid.7621.2)
5 Northwestern University Feinberg School of Medicine, Department of Medical Social Sciences, Chicago, USA (GRID:grid.16753.36) (ISNI:0000 0001 2299 3507)
6 Washington University School of Medicine, Center for Biostatistics and Data Science, St. Louis, USA (GRID:grid.16753.36)
7 RAND Corporation, Santa Monica, USA (GRID:grid.34474.30) (ISNI:0000 0004 0370 7685); Charles R. Drew University of Medicine and Science, Los Angeles, USA (GRID:grid.254041.6) (ISNI:0000 0001 2323 2312)
8 University College London, London, UK (GRID:grid.83440.3b) (ISNI:0000 0001 2190 1201)
9 NYU Langone Grossman School of Medicine, Department of Medicine, New York, USA (GRID:grid.137628.9) (ISNI:0000 0004 1936 8753)
10 Liverpool School of Tropical Medicine, Liverpool, UK (GRID:grid.48004.38) (ISNI:0000 0004 1936 9764)
11 African Comprehensive HIV/AIDS Partnership (ACHAP), Gaborone, Botswana (GRID:grid.463037.5) (ISNI:0000 0001 1485 0178)
12 Target RWE, Durham, USA (GRID:grid.463037.5)
13 Target RWE Company, Durham, USA (GRID:grid.463037.5)
14 University of Botswana, Department of Statistics, Faculty of Social Sciences, Gaborone, Botswana (GRID:grid.7621.2) (ISNI:0000 0004 0635 5486)
15 Botswana Harvard Health Partnership, Gaborone, Botswana (GRID:grid.16753.36); University of Botswana, Faculty of Medicine, Gaborone, Botswana (GRID:grid.7621.2) (ISNI:0000 0004 0635 5486); University College London, London, UK (GRID:grid.83440.3b) (ISNI:0000 0001 2190 1201)