Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into
Nabila Youssouf1,2, Gaone Edwin Mogaetsho3, Thato Moshomo3
1London School of Hygiene and Tropical Medicine, London, UK.
Insights
This study integrates hypertension care into HIV treatment programs in Botswana to improve management for people living with HIV (PLWH). The InterCARE trial aims to close the hypertension care gap by leveraging existing HIV infrastructure.
Area of Science:
- Public Health
- Implementation Science
- Cardiovascular Medicine
Background:
- Hypertension (HTN) and cardiovascular disease (CVD) management is suboptimal in people living with HIV (PLWH) in Botswana, with only 19% HTN control.
- Gaps in HTN care persist despite national guidelines and free healthcare, highlighting a need for innovative strategies.
Purpose of the Study:
- To develop and test strategies for integrating HTN care into existing HIV treatment programs.
- To close the HTN care gap among PLWH in Botswana by leveraging the successful national HIV care infrastructure.
Main Methods:
- The InterCARE trial is a cluster randomized controlled hybrid type 2 effectiveness-implementation trial involving 4652 adults with HIV and HTN.
- Key strategies include healthcare worker training, electronic health record (EHR) integration with reminders, and utilizing treatment partners for social support.
- Formative research and pilot testing were used to adapt and refine implementation strategies based on contextual factors.
Main Results:
- Primary outcomes focus on effectiveness (HTN control) and implementation outcomes (Reach, Effectiveness, Adoption, Implementation, Maintenance).
- Explanatory mixed methods will be used to understand variability in outcomes.
- The study design aims to provide robust data on the integrated care model's success.
Conclusions:
- The InterCARE model, if successful, has the potential for nationwide scale-up in Botswana's HIV clinics.
- Findings will offer valuable insights for scaling up HTN integration into HIV care across the region.
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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