Systems Analysis and Improvement Approach for the Hypertension Care Cascade
SAIA-HTN
2 other identifiers
interventional
305
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
September 13, 2019
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2023
CompletedResults Posted
Study results publicly available
November 27, 2024
CompletedNovember 27, 2024
November 1, 2024
3.2 years
July 1, 2019
September 6, 2024
November 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Controlled Hypertension
The proportion of HIV-infected patients with controlled hypertension among those who were diagnosed with hypertension and picked up their medications after receiving a prescription
Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
Secondary Outcomes (4)
Blood Pressure Screening
Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
Hypertension Diagnosis
Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
Hypertension Treatment Prescription
Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
Hypertension Medication Pick up
Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
Study Arms (2)
Hypertension Systems Analysis and Improvement
EXPERIMENTALEight (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.
Control
NO INTERVENTIONEight (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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Hospital Distrital de Catandica
Catandica, Manica Province, Mozambique
Centro de Saude 1 de Maio
Chimoio, Manica Province, Mozambique
Centro de Saude 7 de Abril
Chimoio, Manica Province, Mozambique
Centro de Saude Eduardo Mondlane
Chimoio, Manica Province, Mozambique
Centro de Saude Nhamaonha
Chimoio, Manica Province, Mozambique
Centro de Saude de Sussundenga
Sussundenga, Manica Province, Mozambique
Centro de Saude Vanduzi
Vanduzi, Manica Province, 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
Búzi, Sofala, Mozambique
Centro de Saude de Dondo
Dondo, Sofala, Mozambique
Centro de Saude de Mafambisse
Dondo, Sofala, Mozambique
Hospital Rural de Nhamatanda
Nhamatanda, Sofala, Mozambique
Hospital Distrital de Manica
Manica, Mozambique
Related Publications (1)
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.
PMID: 32143657DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carmen Hazim
- Organization
- University of Washingtion
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah O Gimbel-Sherr, RN, PhD, MPH
University of Washington
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, School of Nursing: Family and Child Nursing
Study Record Dates
First Submitted
July 1, 2019
First Posted
September 13, 2019
Study Start
July 1, 2020
Primary Completion
September 30, 2023
Study Completion
October 3, 2023
Last Updated
November 27, 2024
Results First Posted
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share