Clinical trial NCT06366386: Integrating Hypertension Management in DSD for HIV
Official title: Leveraging Existing HIV Differentiated Service Delivery Models to Screen and Treat Hypertension in Ugandan Persons Living With HIV
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertension
HIV
Lead sponsor: Infectious Diseases Research Collaboration, Uganda
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include all adult PLHIV receiving HIV care either through clinic or community based ART delivery at the selected health facilities. In this controlled pre-post study, all PLHIV receiving care will be targeted to receive HTN care which will include screening, treatment and monitoring

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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult PLHIV receiving HIV care either through clinic or community based ART delivery at the selected health facilities.

Exclusion Criteria:

* This study will be implemented in the real world setting and the proposed HTN medications are already authorized for use in Uganda. Therefore, we will not exclude any patient from accessing HTN services (screening, treatment and monitoring) unless if any patients decline taking the medicines for whichever reason. However, special patient categories including pregnant mothers, diabetic patients and those with kidney or heart disease will be referred for specialized care.

Primary outcomes:
measure: Number of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure)
timeFrame: Six months after starting treatment of hypertension
measure: % of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure)
timeFrame: Six months after starting treatment of hypertension
Secondary outcomes:
measure: Mean blood pressure (both systolic and diastolic blood pressure)
timeFrame: 12 months after starting treatment
measure: Number and % of hypertensive PLHIV with suppressed Viral load
timeFrame: 12 months after starting treatment
measure: Number and % of patients retained in care
timeFrame: 12 months after starting treatment
measure: Number and % of PLHIV screened for HTN at least once in six months
timeFrame: 12 months after starting treatment
measure: Implementation costs
timeFrame: 12 months after starting treatment
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Research Collaborations (IDRCUganda)
state: Central
Study officials:
affiliation: Infectious Diseases Research Collaboration, Uganda
name: Martin Muddu, MMED
role: PRINCIPAL_INVESTIGATOR
References: