Systems Analysis and Improvement Approach for the Hypertension Care Cascade (SAIA-HTN)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; HIV/AIDS
• Intervention / Treatment: Other: Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mozambique
  • Manica, Mozambique
    • Hospital Distrital de Manica
  • Manica
    • Catandica, Manica, Mozambique
      • Hospital Distrital de Catandica
    • Chimoio, 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
    • Sussundenga, Manica, Mozambique
      • Centro de Saude de Sussundenga
    • Vanduzi, Manica, Mozambique
      • Centro de Saude Vanduzi
  • Sofala
    • Beira, Sofala, 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
    • Buzi, Sofala, Mozambique
      • Hospital Rural de Buzi
    • Dondo, Sofala, Mozambique
      • Centro de Saude de Dondo
    • Dondo, Sofala, Mozambique
      • Centro de Saude de Mafambisse
    • Nhamatanda, Sofala, Mozambique
      • Hospital Rural de Nhamatanda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Screening	The proportion of HIV-infected patients who were screened for hypertension	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	The proportion of HIV-infected patients diagnosed with hypertension among those who were screened	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	The proportion of hypertension medication-eligible HIV patients 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.
Hypertension Medication Pick up	The proportion of HIV patients who are hypertension medication-eligible and pick 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.

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Sarah O Gimbel-Sherr, RN, PhD, MPH, University of Washington

Publications and helpful links

General Publications

• 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. Erratum In: Implement Sci. 2020 Mar 19;15(1):19. doi: 10.1186/s13012-020-00980-6.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: STUDY00006694; R01HL142412 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No