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Systems Analysis and Improvement Approach for the Hypertension Care Cascade

NCT ID: NCT04088656

Last Updated: 2024-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-10-03

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV/AIDS Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Hypertension Systems Analysis and Improvement

Eight (8) health facilities will receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.

Group Type EXPERIMENTAL

Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization

Intervention Type OTHER

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.

Control

Eight (8) health facilities will not receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Sarah Odell Gimbel-Sherr

Associate Professor, School of Nursing: Family and Child Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah O Gimbel-Sherr, RN, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Hospital Distrital de Catandica

Catandica, Manica Province, Mozambique

Site Status

Centro de Saude 1 de Maio

Chimoio, Manica Province, Mozambique

Site Status

Centro de Saude 7 de Abril

Chimoio, Manica Province, Mozambique

Site Status

Centro de Saude Eduardo Mondlane

Chimoio, Manica Province, Mozambique

Site Status

Centro de Saude Nhamaonha

Chimoio, Manica Province, Mozambique

Site Status

Centro de Saude de Sussundenga

Sussundenga, Manica Province, Mozambique

Site Status

Centro de Saude Vanduzi

Vanduzi, Manica Province, Mozambique

Site Status

Centro de Saude de Macurungo

Beira, Sofala, Mozambique

Site Status

Centro de Saude de Manga Mascarenhas

Beira, Sofala, Mozambique

Site Status

Centro de Saude de Manga Nhanconjo

Beira, Sofala, Mozambique

Site Status

Centro de Saude de Ponte Gea

Beira, Sofala, Mozambique

Site Status

Hospital Rural de Buzi

Búzi, Sofala, Mozambique

Site Status

Centro de Saude de Dondo

Dondo, Sofala, Mozambique

Site Status

Centro de Saude de Mafambisse

Dondo, Sofala, Mozambique

Site Status

Hospital Rural de Nhamatanda

Nhamatanda, Sofala, Mozambique

Site Status

Hospital Distrital de Manica

Manica, , Mozambique

Site Status

Countries

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Mozambique

References

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Gimbel S, Mocumbi AO, Asbjornsdottir K, Coutinho J, Andela L, Cebola B, Craine H, Crocker J, Hicks L, Holte S, Hossieke R, Itai E, Levin C, Manaca N, Murgorgo F, Nhumba M, Pfeiffer J, Ramiro I, Ronen K, Sotoodehnia N, Uetela O, Wagner A, Weiner BJ, Sherr K. Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): a hybrid type III cluster randomized trial. Implement Sci. 2020 Mar 6;15(1):15. doi: 10.1186/s13012-020-0973-4.

Reference Type DERIVED
PMID: 32143657 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00006694

Identifier Type: -

Identifier Source: org_study_id

R01HL142412

Identifier Type: NIH

Identifier Source: secondary_id

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