AzTrials
AzTrials

HIV/AIDSSAIA-HTNNCT04088656

Systems Analysis and Improvement Approach for the Hypertension Care Cascade

A study testing Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization in people with HIV/AIDS and Hypertension, run by University of Washington at 16 sites in Mozambique.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV/AIDS, Hypertension
What is being tested?
Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
16 sitesMozambique
Study dates
1 Jul 2020to 3 Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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.

Who cannot join

  • (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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Mozambique16 sites

  • Centro de Saude de Macurungo

    Beira, Sofala

  • Centro de Saude de Manga Mascarenhas

    Beira, Sofala

  • Centro de Saude de Manga Nhanconjo

    Beira, Sofala

  • Centro de Saude de Ponte Gea

    Beira, Sofala

  • Hospital Rural de Buzi

    Búzi, Sofala

  • Hospital Distrital de Catandica

    Catandica, Manica Province

  • Centro de Saude 1 de Maio

    Chimoio, Manica Province

  • Centro de Saude 7 de Abril

    Chimoio, Manica Province

  • Centro de Saude Eduardo Mondlane

    Chimoio, Manica Province

  • Centro de Saude Nhamaonha

    Chimoio, Manica Province

  • Centro de Saude de Dondo

    Dondo, Sofala

  • Centro de Saude de Mafambisse

    Dondo, Sofala

  • Hospital Distrital de Manica

    Manica

  • Hospital Rural de Nhamatanda

    Nhamatanda, Sofala

  • Centro de Saude de Sussundenga

    Sussundenga, Manica Province

  • Centro de Saude Vanduzi

    Vanduzi, Manica Province

Other trials in Mozambique

About this study

Official title: 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.

Being tested
Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
Medical subject headings
Acquired Immunodeficiency Syndrome, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systems Analysis and Improvement Approach for Hypertension Screening and Treatment OptimizationOther

    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.

Study groups in NCT04088656
Study groupRoleWhat they receive
Hypertension Systems Analysis and ImprovementExperimentalEight (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.
Receives: Other: Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
ControlNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Blood Pressure Screening

    The proportion of HIV-infected patients who were screened for hypertension

    Measured: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.

  2. Hypertension Diagnosis

    The proportion of HIV-infected patients diagnosed with hypertension among those who were screened

    Measured: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.

  3. Hypertension Treatment Prescription

    The proportion of hypertension medication-eligible HIV patients receiving a prescription

    Measured: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.

  4. Hypertension Medication Pick up

    The proportion of HIV patients who are hypertension medication-eligible and pick up their medications after receiving a prescription

    Measured: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start1 Jul 2020
  3. Primary completion30 Sep 2023
  4. Study completion3 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04088656
Sponsor's protocol ID
STUDY00006694
Other IDs
R01HL142412
Acronym
SAIA-HTN
Status last verified
Nov 2024
First submitted
1 Jul 2019
Last updated
27 Nov 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Malhotra A, Mocumbi AO, Coutinho MJ, Chidacua MJF, Charama A, Uetela OA, Hazim C, Ramiro I, Sherr K, Gimbel S, Watkins D. Mathematical modeling to assess health and economic impact of cardiovascular interventions and implementation strategies among people living with HIV: SAIA HTN. Implement Sci Commun. 2026 Feb 25;7(1):67. doi: 10.1186/s43058-026-00887-1.

    PubMed 41736102

  • 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.

    PubMed 32143657

Questions about this trial

What is this clinical trial studying?

A study testing Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization in people with HIV/AIDS and Hypertension, run by University of Washington at 16 sites in Mozambique.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Controlled Hypertension (time frame: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04088656, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in