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

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT04088656

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

434

Enrollment

Locations

Arms

Anticipated Duration (Months)

27.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS Hypertension	Other: Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

434 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Blood pressure screening [year 2 through year 4]
The proportion of routine care visits by people living with HIV at which blood pressure is measured

Secondary Outcome Measures

Hypertension diagnosis [year 2 through year 4]
The proportion of confirmed diagnoses of hypertension amongst routine care visits of HIV patients
Hypertension treatment initiation [year 2 through year 4]
The proportion of hypertension medication-eligible HIV patients initiating hypertension treatment
Hypertension medication pick up [year 2 through year 4]
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
Controlled hypertension [year 2 through year 4]
The proportion of HIV patients with hypertension with controlled hypertension at first consult after hypertension treatment initiation
HIV viral load suppression [year 2 through year 4]
The proportion of HIV patients with hypertension with HIV viral load suppressed

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Distrital de Catandica	Catandica	Manica	Mozambique
2	Centro de Saude 1 de Maio	Chimoio	Manica	Mozambique
3	Centro de Saude 7 de Abril	Chimoio	Manica	Mozambique
4	Centro de Saude Eduardo Mondlane	Chimoio	Manica	Mozambique
5	Centro de Saude Nhamaonha	Chimoio	Manica	Mozambique
6	Centro de Saude de Sussundenga	Sussundenga	Manica	Mozambique
7	Centro de Saude Vanduzi	Vanduzi	Manica	Mozambique
8	Centro de Saude de Macurungo	Beira	Sofala	Mozambique
9	Centro de Saude de Manga Mascarenhas	Beira	Sofala	Mozambique
10	Centro de Saude de Manga Nhanconjo	Beira	Sofala	Mozambique
11	Centro de Saude de Ponte Gea	Beira	Sofala	Mozambique
12	Hospital Rural de Buzi	Buzi	Sofala	Mozambique
13	Centro de Saude de Dondo	Dondo	Sofala	Mozambique
14	Centro de Saude de Mafambisse	Dondo	Sofala	Mozambique
15	Hospital Rural de Nhamatanda	Nhamatanda	Sofala	Mozambique
16	Hospital Distrital de Manica	Manica		Mozambique

Sponsors and Collaborators

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

Investigators

Principal Investigator: Sarah O Gimbel-Sherr, RN, PhD, MPH, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sarah Odell Gimbel-Sherr, Associate Professor, School of Nursing: Family and Child Nursing, University of Washington

ClinicalTrials.gov Identifier:

NCT04088656

Other Study ID Numbers:

STUDY00006694
R01HL142412

First Posted:

Sep 13, 2019

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of May 17, 2022