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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL142412 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Screening | The proportion of HIV-infected patients who were screened for hypertension | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah O Gimbel-Sherr, RN, PhD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Distrital de Catandica | Catandica | Manica Province | Mozambique | |||
| Centro de Saude 1 de Maio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41736102 | Derived | 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. | |
| 32143657 | Derived | 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. |
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We randomly allocated health facilities (n=16) to the intervention (n=8) or control (n=8). We consented healthcare workers for qualitative interviews and surveys (n=305) throughout the study. There is no interaction with patients (patients are not consented nor enrolled), however we use the clinical outcomes of patients to determine the effect our implementation strategy (SAIA-HTN). Patient-level data comes from routine data sources and is de-identified. Data from 65,625 patients were captured.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2024 |
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The proportion of HIV-infected patients diagnosed with hypertension among those who were screened |
| 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 | 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 | Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase. |
| Chimoio |
| Manica Province |
| Mozambique |
| Centro de Saude 7 de Abril | Chimoio | Manica Province | Mozambique |
| Centro de Saude Eduardo Mondlane | Chimoio | Manica Province | Mozambique |
| Centro de Saude Nhamaonha | Chimoio | Manica Province | Mozambique |
| Centro de Saude de Sussundenga | Sussundenga | Manica Province | Mozambique |
| Centro de Saude Vanduzi | Vanduzi | Manica Province | 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 | Búzi | 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 |
| FG001 | 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. |
| Patients |
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| COMPLETED |
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| NOT COMPLETED |
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| Intensive Implementation Period |
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| Sustainment Implementation Period |
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Enrolled and consented 305 healthcare workers in intervention sites and none in control sites. Data captured from 35107 patients in intervention sites and 30518 control sites.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | We consent healthcare workers for qualitative collection (n=305) throughout the study. There is no interaction with patients (patients are not consented nor enrolled), however we use the clinical outcomes of patients to determine the effect of SAIA-HTN. Patient-level data comes from routine data sources and is de-identified. Data from 65,625 patients were captured. Age is missing for 52 patients in control sites and 966 patients in intervention sites. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | We consent healthcare workers for qualitative collection (n=305) throughout the study. Sex is missing for 21 healthcare workers. There is no interaction with patients (patients are not consented nor enrolled), however we use the clinical outcomes of patients to determine the effect of SAIA-HTN. Patient-level data comes from routine data sources and is de-identified. Data from 65,625 patients were captured. Sex is missing for 10 patients in control sites and 28 patients in intervention sites. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | We consent healthcare workers for qualitative collection (n=305) throughout the study. There is no interaction with patients (patients are not consented nor enrolled), however we use the clinical outcomes of patients to determine the effect of SAIA-HTN. Patient-level data comes from routine data sources and is de-identified. Data from 65,625 patients were captured. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | Healthcare workers and Patients |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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 | Posted | Count of Participants | Participants | Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase. |
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| Secondary | Blood Pressure Screening | The proportion of HIV-infected patients who were screened for hypertension | Number of new and existing HIV-infected patients attending enrolled facilities | Posted | Count of Participants | Participants | Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase. |
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| Secondary | Hypertension Diagnosis | The proportion of HIV-infected patients diagnosed with hypertension among those who were screened | Number of new and existing HIV-infected patients attending enrolled facilities who were screened for hypertension | Posted | Count of Participants | Participants | Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase. |
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| Secondary | Hypertension Treatment Prescription | The proportion of hypertension medication-eligible HIV patients receiving a prescription | Number of new and existing HIV-infected patients attending enrolled facilities who were diagnosed with hypertension (i.e. medication-eligible) | Posted | Count of Participants | Participants | Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase. |
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| Secondary | Hypertension Medication Pick up | The proportion of HIV patients who are hypertension medication-eligible and pick up their medications after receiving a prescription | Number of new and existing HIV-infected patients attending enrolled facilities who were diagnosed with hypertension (i.e. medication-eligible) and prescribed hypertension medication | Posted | Count of Participants | Participants | Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase. |
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Through study completion, an average of 3 years.
Definition of adverse event / serious adverse event does not differ from that of clinicaltrials.gov. Adverse Events were only monitored/assessed in healthcare worker participants. No healthcare worker participants were at risk in the control arm as no intervention was applied and thus no healthcare workers were exposed or at risk. All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were not monitored/assessed in patient participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 305 | 0 | 305 | 0 | 305 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmen Hazim | University of Washingtion | 4042451459 | chazim@uw.edu |
| Oct 23, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Patients |
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| Patients |
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| Patients |
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| OG004 | Control Arm - Intensive Implementation Phase | Newly eligible HIV-infected patients attending control facilities during intensive implementation phase |
| OG005 | Control Arm - Sustainment Phase | Newly eligible HIV-infected patients attending control facilities during sustainment phase |
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| OG004 | Control Arm - Intensive Implementation Phase | Newly eligible HIV-infected patients attending control facilities during intensive implementation phase |
| OG005 | Control Arm - Sustainment Phase | Newly eligible HIV-infected patients attending control facilities during sustainment phase |
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Newly eligible HIV-infected patients attending control facilities during baseline phase
| OG004 | Control Arm - Intensive Implementation Phase | Newly eligible HIV-infected patients attending control facilities during intensive implementation phase |
| OG005 | Control Arm - Sustainment Phase | Newly eligible HIV-infected patients attending control facilities during sustainment phase |
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Newly eligible HIV-infected patients attending control facilities during baseline phase |
| OG004 | Control Arm - Intensive Implementation Phase | Newly eligible HIV-infected patients attending control facilities during intensive implementation phase |
| OG005 | Control Arm - Sustainment Phase | Newly eligible HIV-infected patients attending control facilities during sustainment phase |
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