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

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Trial summary

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.

City, postcode or hospital

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.

Conditions: HIV/AIDS, Hypertension
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 group	Role	What they receive
Hypertension Systems Analysis and Improvement	Experimental	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. Receives: Other: Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
Control	No intervention	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 being measured

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

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)

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.
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.
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.
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 Jul 20203 Oct 2023

First posted13 Sep 2019
Study start1 Jul 2020
Primary completion30 Sep 2023
Study completion3 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Systems Analysis and Improvement Approach to Optimize the Hypertension Diagnosis and Care Cascade for HIV-infected Individuals
ClinicalTrials.gov ID: NCT04088656
Acronym / sponsor ID: SAIA-HTN / STUDY00006694
Conditions: HIV/AIDS, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 305 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 1 Jul 2020 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 3 Oct 2023 (actual)
First posted: 13 Sep 2019 (actual)
Results: Posted 27 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hypertension Systems Analysis and Improvement	Experimental	Other: Systems Analysis and Improvement Approach for Hypertension Screening and Treatment OptimizationEight (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.
Control	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

(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.

Key exclusion criteria (1 listed)

(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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Systems Analysis and Improvement Approach for Hypertension Screening and Treatment OptimizationThe 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.	Other	Hypertension Systems Analysis and Improvement

Primary outcome

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.
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

4 secondary outcomes

Blood Pressure Screening
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.
Hypertension Diagnosis
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.
Hypertension Treatment Prescription
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.
Hypertension Medication Pick up
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.

Results and safety

Results posted to the registry on 27 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hypertension Systems Analysis and Improvement	12,307	12,307
Control	10,042	10,042

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Intervention Arm - Baseline Phase n = 74	Intervention Arm - Intensive Implementation Phase n = 1447	Intervention Arm - Sustainment Phase n = 157	Control Arm - Baseline Phase n = 52	Control Arm - Intensive Implementation Phase n = 1430	Control Arm - Sustainment Phase n = 161
Value	3	315	37	1	82	14

Population analysed: Number of new and existing HIV-infected patients attending enrolled facilities who were diagnosed with hypertension and picked up their medications after receiving a prescription

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 3 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hypertension Systems Analysis and Improvement	0 of 305 (0%)	0 of 305 (0%)	0 of 305
Control	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41736102Malhotra 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.
Derived from this study: PubMed 32143657Gimbel 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah O Gimbel-Sherr, RN, PhD, MPH principal investigator

University of Washington

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.