search
Back to results

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

Primary Purpose

HIV/AIDS, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Distrital de CatandicaRecruiting
  • Centro de Saude 1 de MaioRecruiting
  • Centro de Saude 7 de AbrilRecruiting
  • Centro de Saude Eduardo MondlaneRecruiting
  • Centro de Saude NhamaonhaRecruiting
  • Centro de Saude de SussundengaRecruiting
  • Centro de Saude VanduziRecruiting
  • Centro de Saude de MacurungoRecruiting
  • Centro de Saude de Manga MascarenhasRecruiting
  • Centro de Saude de Manga NhanconjoRecruiting
  • Centro de Saude de Ponte GeaRecruiting
  • Hospital Rural de BuziRecruiting
  • Centro de Saude de DondoRecruiting
  • Centro de Saude de MafambisseRecruiting
  • Hospital Rural de NhamatandaRecruiting
  • Hospital Distrital de ManicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hypertension Systems Analysis and Improvement

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood pressure screening
The proportion of routine care visits by people living with HIV at which blood pressure is measured

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2019
Last Updated
May 16, 2022
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04088656
Brief Title
Systems Analysis and Improvement Approach for the Hypertension Care Cascade
Acronym
SAIA-HTN
Official Title
Systems Analysis and Improvement Approach to Optimize the Hypertension Diagnosis and Care Cascade for HIV-infected Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
434 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypertension Systems Analysis and Improvement
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure screening
Description
The proportion of routine care visits by people living with HIV at which blood pressure is measured
Time Frame
year 2 through year 4
Secondary Outcome Measure Information:
Title
Hypertension diagnosis
Description
The proportion of confirmed diagnoses of hypertension amongst routine care visits of HIV patients
Time Frame
year 2 through year 4
Title
Hypertension treatment initiation
Description
The proportion of hypertension medication-eligible HIV patients initiating hypertension treatment
Time Frame
year 2 through year 4
Title
Hypertension medication pick up
Description
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
Time Frame
year 2 through year 4
Title
Controlled hypertension
Description
The proportion of HIV patients with hypertension with controlled hypertension at first consult after hypertension treatment initiation
Time Frame
year 2 through year 4
Title
HIV viral load suppression
Description
The proportion of HIV patients with hypertension with HIV viral load suppressed
Time Frame
year 2 through year 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah O Gimbel-Sherr, RN, PhD, MPH
Phone
206-616-5064
Email
sgimbel@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah O Gimbel-Sherr, RN, PhD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Distrital de Catandica
City
Catandica
State/Province
Manica
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel S Tinga
Phone
+258 847601108
First Name & Middle Initial & Last Name & Degree
Maxinel Chidacua
Email
maxinel.chidacua@healthallianceinternational.org
Facility Name
Centro de Saude 1 de Maio
City
Chimoio
State/Province
Manica
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara A Jofrisse
Phone
+258 848651959
First Name & Middle Initial & Last Name & Degree
Maxinel Chidacua
Email
maxinel.chidacua@healthallianceinternational.org
Facility Name
Centro de Saude 7 de Abril
City
Chimoio
State/Province
Manica
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzana A Chinona
Phone
+258 842629331
First Name & Middle Initial & Last Name & Degree
Maxinel Chidacua
Email
maxinel.chidacua@healthallianceinternational.org
Facility Name
Centro de Saude Eduardo Mondlane
City
Chimoio
State/Province
Manica
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aminosca da Cecilia Alberto
Phone
+258 848214481
First Name & Middle Initial & Last Name & Degree
Maxinel Chidacua
Email
maxinel.chidacua@healthallianceinternational.org
Facility Name
Centro de Saude Nhamaonha
City
Chimoio
State/Province
Manica
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana R Jose
Phone
+258 848664229
First Name & Middle Initial & Last Name & Degree
Maxinel Chidacua
Email
maxinel.chidacua@healthallianceinternational.org
Facility Name
Centro de Saude de Sussundenga
City
Sussundenga
State/Province
Manica
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orlando J Ndramo
Phone
+258 846207540
First Name & Middle Initial & Last Name & Degree
Maxinel Chidacua
Email
maxinel.chidacua@healthallianceinternational.org
Facility Name
Centro de Saude Vanduzi
City
Vanduzi
State/Province
Manica
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfazema A Marques
Phone
+258 848040891
First Name & Middle Initial & Last Name & Degree
Maxinel Chidacua
Email
maxinel.chidacua@healthallianceinternational.org
Facility Name
Centro de Saude de Macurungo
City
Beira
State/Province
Sofala
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Octavio M Mora da Cruz
Phone
+258 846486950
First Name & Middle Initial & Last Name & Degree
Amido Charama
Email
amido.charama@healthallianceinternational.org
Facility Name
Centro de Saude de Manga Mascarenhas
City
Beira
State/Province
Sofala
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo B Warota
Phone
+258 844453446
First Name & Middle Initial & Last Name & Degree
Amido Charama
Email
amido.charama@healthallianceinternational.org
Facility Name
Centro de Saude de Manga Nhanconjo
City
Beira
State/Province
Sofala
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alcides A Couto
Phone
+258 843833688
First Name & Middle Initial & Last Name & Degree
Amido Charama
Email
amido.charama@healthallianceinternational.org
Facility Name
Centro de Saude de Ponte Gea
City
Beira
State/Province
Sofala
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliao M Armando
Phone
+258 844029253
First Name & Middle Initial & Last Name & Degree
Amido Charama
Email
amido.charama@healthallianceinternational.org
Facility Name
Hospital Rural de Buzi
City
Buzi
State/Province
Sofala
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Macua E Chizimo Boroma
Phone
+258 843813258
First Name & Middle Initial & Last Name & Degree
Amido Charama
Email
amido.charama@healthallianceinternational.org
Facility Name
Centro de Saude de Dondo
City
Dondo
State/Province
Sofala
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos L Rafael
Phone
+258 844620643
First Name & Middle Initial & Last Name & Degree
Amido Charama
Email
amido.charama@healthallianceinternational.org
Facility Name
Centro de Saude de Mafambisse
City
Dondo
State/Province
Sofala
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lanquene M Matimbe
Phone
+258 840265840
First Name & Middle Initial & Last Name & Degree
Amido Charama
Email
amido.charama@healthallianceinternational.org
Facility Name
Hospital Rural de Nhamatanda
City
Nhamatanda
State/Province
Sofala
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelino J Ofumane
Phone
+258 845597322
First Name & Middle Initial & Last Name & Degree
Amido Charama
Email
amido.charama@healthallianceinternational.org
Facility Name
Hospital Distrital de Manica
City
Manica
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abilio Jone
Phone
+258 847463410
First Name & Middle Initial & Last Name & Degree
Maxinel Chidacua
Email
maxinel.chidacua@healthallianceinternational.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32143657
Citation
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.
Results Reference
derived

Learn more about this trial

Systems Analysis and Improvement Approach for the Hypertension Care Cascade

We'll reach out to this number within 24 hrs