Integrating Hypertension Management in DSD for HIV

NCT06366386 | Not Yet Recruiting

• 1 other identifier: 5K43TW011963-03
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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. 1.What are the perspectives of patients (hypertensive PLHIV) on integrating hypertension care in community ART delivery models of HIV care?
2. 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. 3.What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda?
4. 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. 5.What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda?
6. 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.

Conditions

Hypertension; HIV

Outcome Measures

Primary Outcomes (2)

• Number of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure)

  Number of PLHIV with HTN who will achieve Blood pressure control (both systolic and diastolic blood pressure) after starting treatment.

  Six months after starting treatment of hypertension

• % of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure)

  Proportion of PLHIV with HTN who will achieve Blood pressure control (both systolic and diastolic blood pressure) after starting

  Six months after starting treatment of hypertension

Secondary Outcomes (5)

• Mean blood pressure (both systolic and diastolic blood pressure)

  12 months after starting treatment

• Number and % of hypertensive PLHIV with suppressed Viral load

  12 months after starting treatment

• Number and % of patients retained in care

  12 months after starting treatment

• Number and % of PLHIV screened for HTN at least once in six months

  12 months after starting treatment

• Implementation costs

  12 months after starting treatment

Study Arms (1)

Persons living with HIV and hypertension

Persons living with HIV and hypertension aged 18 years and above will receive integrated screening (blood pressure measurement) and treatment of hypertension in their respective models of HIV care. The models of HIV care include the clinic based HIV care and community based HIV care. Treatment of hypertension will be based on a simplified one page protocol adapted from the WHO HEARTS packages for hypertension control. Health workers will be trained to titrate hypertension medications for PLHIV with hypertension using the three medications is a step wise manner: Amlodipine, Hydrochlorothiazide and Losartan.

Behavioral: Screening and treatment of hypertension among PLHIV in DSD models for HIV

Interventions

Screening and treatment of hypertension among PLHIV in DSD models for HIV BEHAVIORAL

In all DSD models of HIV, participants will receive screening for HTN (BP measurement), treatment of hypertension using a simplified protocol of amlodipine, hydrochlorothiazide and Losartan in a stepwise manner and laboratory monitoring for HTN medication adverse events.

Also known as: Adapted World Health Organization (WHO) HEARTS intervention for hypertension management in DSD for HIV

Persons living with HIV and hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Infectious Diseases Research Collaboration, Uganda: lead

Study Sites (1)

Infectious Diseases Research Collaborations (IDRCUganda)

Kampala, Central Region, +256, Uganda

Location

MeSH Terms

Conditions

Hypertension

Interventions

Mass Screening; Seroconversion; World Health Organization

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Immune System Phenomena; United Nations; International Agencies; Organizations; Health Care Economics and Organizations

Study Officials

• Martin Muddu, MMED

  Infectious Diseases Research Collaboration, Uganda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Bakashaba, Masters

CONTACT

+256702802277; ebakashaba@idrc-uganda.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 15, 2024
• Study Start: June 15, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)