Systems Analysis and Improvement Approach for the Hypertension Care Cascade

Not Applicable

Completed

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

• Registration Number: NCT04088656
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-13
• Study Start: 2020-07-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-03
• Results First Submitted: 2024-09-06
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Results First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertension Systems Analysis and Improvement	Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization	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.

Primary Outcome Measures

Name	Time	Method
Controlled Hypertension	Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.	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

Secondary Outcome Measures

Name	Time	Method
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.	The proportion of HIV-infected patients who were screened for hypertension
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.	The proportion of HIV-infected patients diagnosed with hypertension among those who were screened
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.	The proportion of hypertension medication-eligible HIV patients receiving a prescription
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.	The proportion of HIV patients who are hypertension medication-eligible and pick up their medications after receiving a prescription

Trial Locations

Locations (16)

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 Sussundenga; 🇲🇿 Sussundenga, Manica, Mozambique

Centro de Saude Vanduzi; 🇲🇿 Vanduzi, Manica, 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

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