Systems Analysis and Improvement Approach for the Hypertension Care Cascade

Hypertension Clinical Trial

— SAIA-HTN  

Official title:

Systems Analysis and Improvement Approach to Optimize the Hypertension Diagnosis and Care Cascade for HIV-infected Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088656
• Other study ID #: STUDY00006694
• Secondary ID: R01HL142412
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: October 2024

Study information

• Verified date: May 2022
• Source: University of Washington
• Contact: Sarah O Gimbel-Sherr, RN, PhD, MPH
• Phone: 206-616-5064
• Email: sgimbel[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As undiagnosed and untreated hypertension is one of the largest drivers of cardiovascular disease in sub-Saharan Africa approaches are needed to optimize the hypertension care cascade. The HIV treatment platform in low and middle income countries provides a robust, scalable foundation to address other chronic care priorities, such as hypertension. This proposal will evaluate an evidence-based intervention designed to improve chronic care services (the Systems Analysis and Improvement Approach (SAIA)) for hypertension detection and management in people living with HIV, and will build evidence on how to achieve rapid, sustainable and scalable improvements in services that can dramatically improve population health in resource-limited countries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 434
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• (A1) Frontline Health Workers / Health Facility Managers currently working in outpatient, emergency or related (pharmacy, laboratory) services at one of the study clinics in Manica and Sofala provinces, Mozambique; (A2) District Health Supervisors currently employed in a study district in Manica and Sofala provinces, Mozambique regularly engaged in service provision or management of HIV-infected and/or hypertensive populations; and (A3) Clinical Experts currently working in Mozambique in the clinical delivery of HIV and/or hypertension care and treatment or (B1) People Living with HIV >14 years old (B2) access HIV care and treatment services via outpatient/emergency services in study clinics. >14 years is being used as the current Ministry of Health forms only use the age bounds of <15y, >14y and there is significant concern by the Mozambican Ministry of Health to minimize additional data collection when not absolutely necessary.

Exclusion Criteria:

• (A1) not currently working as a Frontline Health Worker/Health Facility Manager at a participating study facility or (A2) not currently working as a District Health Supervisor in a participating district or (A3) not currently working in Mozambique in the clinical delivery of HIV and/or hypertension care and treatment or (B1) HIV-negative or of unknown status or (B2) <15 years old or age not recorded, (B3) or pregnant or postpartum.

Related Conditions & MeSH terms

• HIV/AIDS
• Hypertension

Intervention

Other:
• Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
The Systems Analysis and Improvement Approach to Optimize the Hypertension Care Cascade for People Living with HIV (SAIA-HTN) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by study nurses and district managers in intervention facilities. Components of the intervention include joint care cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally improve hypertension screening, diagnosis, treatment and care in the HIV+ population at intervention health facilities.

Locations

Country	Name	City	State
Mozambique	Centro de Saude de Macurungo	Beira	Sofala
Mozambique	Centro de Saude de Manga Mascarenhas	Beira	Sofala
Mozambique	Centro de Saude de Manga Nhanconjo	Beira	Sofala
Mozambique	Centro de Saude de Ponte Gea	Beira	Sofala
Mozambique	Hospital Rural de Buzi	Buzi	Sofala
Mozambique	Hospital Distrital de Catandica	Catandica	Manica
Mozambique	Centro de Saude 1 de Maio	Chimoio	Manica
Mozambique	Centro de Saude 7 de Abril	Chimoio	Manica
Mozambique	Centro de Saude Eduardo Mondlane	Chimoio	Manica
Mozambique	Centro de Saude Nhamaonha	Chimoio	Manica
Mozambique	Centro de Saude de Dondo	Dondo	Sofala
Mozambique	Centro de Saude de Mafambisse	Dondo	Sofala
Mozambique	Hospital Distrital de Manica	Manica
Mozambique	Hospital Rural de Nhamatanda	Nhamatanda	Sofala
Mozambique	Centro de Saude de Sussundenga	Sussundenga	Manica
Mozambique	Centro de Saude Vanduzi	Vanduzi	Manica

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure screening	The proportion of routine care visits by people living with HIV at which blood pressure is measured	year 2 through year 4
Secondary	Hypertension diagnosis	The proportion of confirmed diagnoses of hypertension amongst routine care visits of HIV patients	year 2 through year 4
Secondary	Hypertension treatment initiation	The proportion of hypertension medication-eligible HIV patients initiating hypertension treatment	year 2 through year 4
Secondary	Hypertension medication pick up	The proportion of HIV patients, who are newly diagnosed with hypertension and eligible for hypertension medication, who pick up their medications after receiving a prescription	year 2 through year 4
Secondary	Controlled hypertension	The proportion of HIV patients with hypertension with controlled hypertension at first consult after hypertension treatment initiation	year 2 through year 4
Secondary	HIV viral load suppression	The proportion of HIV patients with hypertension with HIV viral load suppressed	year 2 through year 4