Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into existing HIV services package in Botswana (InterCARE)

Youssouf, Nabila, Mogaetsho, Gaone Edwin, Moshomo, Thato, Gaolathe, Tendani, Ponatshego, Ponego, Ramotsababa, Mareko, Molefe-Baikai, Onkabetse Julia, Dintwa, Evelyn, Kiki, Tsaone, Van Pelt, Amelia E., Steger-May, Karen, Bogart, Laura M., Jaffar, Shabbar, Gala, Pooja, Wang, Duolao ORCID: https://orcid.org/0000-0003-2788-2464, Seipone, Khumo, Bennett, Kara, Hurwitz, Kathleen Wirth, Kebotsamang, Kago, Hirschhorn, Lisa R. and Mosepele, Mosepele (2024) 'Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into existing HIV services package in Botswana (InterCARE)'. Trials, Vol 25, Issue 1, e510.

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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.

Item Type:	Article
Subjects:	W General Medicine. Health Professions > Health Services. Patients and Patient Advocacy > W 84 Health services. Delivery of health care WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections WG Cardiovascular System > WG 120 Cardiovascular diseases WG Cardiovascular System > WG 20 Research (General)
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1186/s13063-024-08333-0
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	08 Aug 2024 11:08
Last Modified:	08 Aug 2024 11:08
URI:	https://archive.lstmed.ac.uk/id/eprint/25018

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