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

Nabila Youssouf, Gaone Edwin Mogaetsho, Thato Moshomo, Tendani Gaolathe, Ponego Ponatshego, Mareko Ramotsababa, Onkabetse Julia Molefe-Baikai, Evelyn Dintwa, Tsaone Kiki, Amelia E. Van Pelt, Karen Steger-May, Laura M. Bogart, Shabbar Jaffar, Pooja Gala, Duolao Wang, Khumo Seipone, Kara Bennett, Kathleen Wirth Hurwitz, Kago Kebotsamang, Lisa R. Hirschhorn*Mosepele Mosepele*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number510
JournalTrials
Volume25
Issue number1
DOIs
StatePublished - Dec 2024

Funding

This trial is funded by the United States of America National Institute of Health (NIH) via the National Heart, Lung and Blood Institute (NHLBI): Federal Award Identification Number (FAIN) UG3HL154499. The funders had a role in the study design but have no role in the data collection nor in the future analysis, interpretation, or writing of the manuscript.

Keywords

  • Botswana
  • Cardiovascular disease
  • Care integration
  • Electronic health record
  • HIV
  • Hypertension
  • Implementation research
  • Treatment partners

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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