Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366386
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-03-18
Brief Title:
Integrating Hypertension Management in DSD for HIV
Sponsor:
Infectious Diseases Research Collaboration Uganda
Organization:
Infectious Diseases Research Collaboration Uganda
Study Overview
Official Title:
Leveraging Existing HIV Differentiated Service Delivery Models to Screen and Treat Hypertension in Ugandan Persons Living With HIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HTN-DSD
Brief Summary:
The goal of this implementation science study is to design evidence based and stakeholder informed implementation strategies to integrate the management of hypertension HTN into existing community anti-retro-viral treatment ART delivery models of HIV care in Uganda and evaluate their effectiveness and implementation outcomes The main questions it aims to answer are
1 What are the perspectives of patients hypertensive PLHIV on integrating hypertension care in community ART delivery models of HIV care
2 What are the perspectives of health care providers district leaders and policymakers perspectives on integrating hypertension care in community ART delivery models of HIV care
3 What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda
4 What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda
5 What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda
6 What is the cumulative incidence types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN Investigators will use qualitative research methods to explore key stakeholders perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda design implementation strategies that integrate the management of hypertension into existing community ART delivery models determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models determine the cumulative incidence types and severity of medication-related adverse events and their predictors and assess the patients and provider costs health related quality of life cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda
1 What are the perspectives of patients hypertensive PLHIV on integrating hypertension care in community ART delivery models of HIV care
2 What are the perspectives of health care providers district leaders and policymakers perspectives on integrating hypertension care in community ART delivery models of HIV care
3 What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda
4 What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda
5 What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda
6 What is the cumulative incidence types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN Investigators will use qualitative research methods to explore key stakeholders perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda design implementation strategies that integrate the management of hypertension into existing community ART delivery models determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models determine the cumulative incidence types and severity of medication-related adverse events and their predictors and assess the patients and provider costs health related quality of life cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda
Detailed Description:
Introduction Over a billion people worldwide have hypertension HTN although 46 are unaware Approximately a third of adult people living with HIV PLHIV have hypertension HTN partly due to increased longevity HIV related inflammation and antiretroviral therapy ART use The high prevalence of HTN exposes PLHIV to an increased risk of ischemic heart disease stroke and kidney disease Community delivery of antiretroviral therapy ART improves retention and viral load suppression for PLHIV However HTN management is not yet integrated into community ART delivery models in which over 50 of PLHIV receive care because initial integration efforts are focused at health facilities Additionally the proportion of hypertensive PLHIV with controlled blood pressure is still low 5 in Uganda Thus integrating the management of HTN into community ART models could improve HTN control in PLHIV and reduce the cardiovascular diseases CVD risk Treating HIV HTN and other non-communicable diseases NCDs concurrently raises concerns for medication-related adverse events including but not limited to adverse signs and symptoms cough angioedema peripheral edema and laboratory abnormalities hypo-hyper-kalemia hyponatremia hyperglycemia hyperlipidemia Yet little is known about the burden and profile of such adverse events among patients concurrently treated for HIV and HTN in low-income countries like Uganda Availability of such information is likely to improve the safety and acceptability of integrated HIV-HTN care
Aims This study aims 1 To explore key stakeholders perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda 2 To design implementation strategies that integrate the management of hypertension into existing community ART delivery models 3 To determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models and 4 To evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models 5 To determine the cumulative incidence types and severity of medication-related adverse events and their predictors 6 To assess the patients and provider costs health related quality of life cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda
Methods Investigators will use mixed methods research to conduct a formative study to explore stakeholders perspectives and preferences of integrating HTN care into community ART delivery models Using the Consolidated Framework for Implementation Research CFIR investigators will determine factors that influence the integration of HTN management into community ART models Investigators will then design implementation strategies to integrate HTN management into community ART models using group model building Investigators will do this through rigorous engagement of stakeholders who participate in the implementation of HIV and HTN services These will include healthcare providers health leaders at district and health facilities as well as patient representatives To develop generalizable implementation strategies investigators will use the widely validated CFIR-Expert Recommendations to Implement Change CFIR-ERIC tool to classify the strategies Investigators will then name define and operationalize the implementation strategies according to Proctor et al Then investigators will implement and determine effectiveness of the implementation strategies using an interrupted time series analysis ITSA across four health facilities and their community ART delivery models in addition investigators will leverage a cohort of ageing PLHIV receiving both HIV and HTN care to conduct baseline laboratory investigations with a repeat of these tests at intervals of one and six months post initiation of HTN medicines to profile adverse events associated with HTN medications among these PLHIV Finally investigators will evaluate the implementation and process outcomes of the implementation strategies Investigators will do this by quantifying HIV and HTN indicators and qualitatively exploring stakeholders barriers and facilitators towards the integrated management of HTN within community ART models Investigators will use the Reach Effectiveness Adoption Implementation and Maintenance RE-AIM framework of implementation science to conduct the process evaluation
Implications of the proposed research This study will use rigorous implementation science methods to design implementation strategies and determine their effectiveness in integrating HTN management into community-based ART delivery models The implementation strategies may lead to improved dual control of HIV and HTN in patients who receive care in the community By profiling HTN medication-related adverse events and their predictors among an ageing HIV population our study will provide a benchmark for such events as well as build capacity on monitoring and managing medication-related adverse events among PLHIV with HTN and other NCDs Our theory of change for integrating HTN management into community-based ART delivery models will inform Ugandan HIV and HTN guidelines and could be generalizable to other low income settings Study findings will also demonstrate the utility of implementation science in the chronic care of HTN and HIV in the community
Aims This study aims 1 To explore key stakeholders perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda 2 To design implementation strategies that integrate the management of hypertension into existing community ART delivery models 3 To determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models and 4 To evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models 5 To determine the cumulative incidence types and severity of medication-related adverse events and their predictors 6 To assess the patients and provider costs health related quality of life cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda
Methods Investigators will use mixed methods research to conduct a formative study to explore stakeholders perspectives and preferences of integrating HTN care into community ART delivery models Using the Consolidated Framework for Implementation Research CFIR investigators will determine factors that influence the integration of HTN management into community ART models Investigators will then design implementation strategies to integrate HTN management into community ART models using group model building Investigators will do this through rigorous engagement of stakeholders who participate in the implementation of HIV and HTN services These will include healthcare providers health leaders at district and health facilities as well as patient representatives To develop generalizable implementation strategies investigators will use the widely validated CFIR-Expert Recommendations to Implement Change CFIR-ERIC tool to classify the strategies Investigators will then name define and operationalize the implementation strategies according to Proctor et al Then investigators will implement and determine effectiveness of the implementation strategies using an interrupted time series analysis ITSA across four health facilities and their community ART delivery models in addition investigators will leverage a cohort of ageing PLHIV receiving both HIV and HTN care to conduct baseline laboratory investigations with a repeat of these tests at intervals of one and six months post initiation of HTN medicines to profile adverse events associated with HTN medications among these PLHIV Finally investigators will evaluate the implementation and process outcomes of the implementation strategies Investigators will do this by quantifying HIV and HTN indicators and qualitatively exploring stakeholders barriers and facilitators towards the integrated management of HTN within community ART models Investigators will use the Reach Effectiveness Adoption Implementation and Maintenance RE-AIM framework of implementation science to conduct the process evaluation
Implications of the proposed research This study will use rigorous implementation science methods to design implementation strategies and determine their effectiveness in integrating HTN management into community-based ART delivery models The implementation strategies may lead to improved dual control of HIV and HTN in patients who receive care in the community By profiling HTN medication-related adverse events and their predictors among an ageing HIV population our study will provide a benchmark for such events as well as build capacity on monitoring and managing medication-related adverse events among PLHIV with HTN and other NCDs Our theory of change for integrating HTN management into community-based ART delivery models will inform Ugandan HIV and HTN guidelines and could be generalizable to other low income settings Study findings will also demonstrate the utility of implementation science in the chronic care of HTN and HIV in the community
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None