HIV/AIDS, Hypertension
Conditions
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.
Interventions
OTHERSystems 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Controlled Hypertension | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Screening | 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 who were screened for hypertension |
| Hypertension Diagnosis | 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 diagnosed with hypertension among those who were screened |
| Hypertension Treatment Prescription | 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 hypertension medication-eligible HIV patients receiving a prescription |
| Hypertension Medication Pick up | 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 patients who are hypertension medication-eligible and pick up their medications after receiving a prescription |
Countries
Mozambique
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35,412 |
| 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. | 30,518 |
| Total | 65,930 |
Baseline characteristics
| Characteristic | Hypertension Systems Analysis and Improvement | Control | Total |
|---|---|---|---|
| Age, Categorical Healthcare Workers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Healthcare Workers >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Healthcare Workers Between 18 and 65 years | 305 Participants | 0 Participants | 305 Participants |
| Age, Categorical Patients <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Patients >=65 years | 676 Participants | 595 Participants | 1271 Participants |
| Age, Categorical Patients Between 18 and 65 years | 33465 Participants | 29871 Participants | 63336 Participants |
| Race (NIH/OMB) Healthcare Workers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers Black or African American | 305 Participants | 0 Participants | 305 Participants |
| Race (NIH/OMB) Healthcare Workers More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers White | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Black or African American | 35107 Participants | 30518 Participants | 65625 Participants |
| Race (NIH/OMB) Patients More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mozambique | 35412 Healthcare workers and Patients | 30518 Healthcare workers and Patients | 65930 Healthcare workers and Patients |
| Sex: Female, Male Healthcare Workers Female | 132 Participants | 0 Participants | 132 Participants |
| Sex: Female, Male Healthcare Workers Male | 152 Participants | 0 Participants | 152 Participants |
| Sex: Female, Male Patients Female | 22718 Participants | 18821 Participants | 41539 Participants |
| Sex: Female, Male Patients Male | 12361 Participants | 11687 Participants | 24048 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 305 | 0 / 0 |
| other Total, other adverse events | 0 / 305 | 0 / 0 |
| serious Total, serious adverse events | 0 / 305 | 0 / 0 |
Outcome results
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
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.
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm - Baseline Phase | Controlled Hypertension | 3 Participants |
| Intervention Arm - Intensive Implementation Phase | Controlled Hypertension | 315 Participants |
| Intervention Arm - Sustainment Phase | Controlled Hypertension | 37 Participants |
| Control Arm - Baseline Phase | Controlled Hypertension | 1 Participants |
| Control Arm - Intensive Implementation Phase | Controlled Hypertension | 82 Participants |
| Control Arm - Sustainment Phase | Controlled Hypertension | 14 Participants |
Secondary
Blood Pressure Screening
The proportion of HIV-infected patients who were screened for 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.
Population: Number of new and existing HIV-infected patients attending enrolled facilities
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm - Baseline Phase | Blood Pressure Screening | 4275 Participants |
| Intervention Arm - Intensive Implementation Phase | Blood Pressure Screening | 20359 Participants |
| Intervention Arm - Sustainment Phase | Blood Pressure Screening | 2182 Participants |
| Control Arm - Baseline Phase | Blood Pressure Screening | 3351 Participants |
| Control Arm - Intensive Implementation Phase | Blood Pressure Screening | 17882 Participants |
| Control Arm - Sustainment Phase | Blood Pressure Screening | 2556 Participants |
Secondary
Hypertension Diagnosis
The proportion of HIV-infected patients diagnosed with hypertension among those who were screened
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.
Population: Number of new and existing HIV-infected patients attending enrolled facilities who were screened for hypertension
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm - Baseline Phase | Hypertension Diagnosis | 318 Participants |
| Intervention Arm - Intensive Implementation Phase | Hypertension Diagnosis | 2247 Participants |
| Intervention Arm - Sustainment Phase | Hypertension Diagnosis | 244 Participants |
| Control Arm - Baseline Phase | Hypertension Diagnosis | 288 Participants |
| Control Arm - Intensive Implementation Phase | Hypertension Diagnosis | 2442 Participants |
| Control Arm - Sustainment Phase | Hypertension Diagnosis | 404 Participants |
Secondary
Hypertension Medication Pick up
The proportion of HIV patients who are hypertension medication-eligible and pick up their medications after receiving a 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.
Population: Number of new and existing HIV-infected patients attending enrolled facilities who were diagnosed with hypertension (i.e. medication-eligible) and prescribed hypertension medication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm - Baseline Phase | Hypertension Medication Pick up | 74 Participants |
| Intervention Arm - Intensive Implementation Phase | Hypertension Medication Pick up | 1447 Participants |
| Intervention Arm - Sustainment Phase | Hypertension Medication Pick up | 157 Participants |
| Control Arm - Baseline Phase | Hypertension Medication Pick up | 52 Participants |
| Control Arm - Intensive Implementation Phase | Hypertension Medication Pick up | 1430 Participants |
| Control Arm - Sustainment Phase | Hypertension Medication Pick up | 161 Participants |
Secondary
Hypertension Treatment Prescription
The proportion of hypertension medication-eligible HIV patients receiving a 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.
Population: Number of new and existing HIV-infected patients attending enrolled facilities who were diagnosed with hypertension (i.e. medication-eligible)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm - Baseline Phase | Hypertension Treatment Prescription | 221 Participants |
| Intervention Arm - Intensive Implementation Phase | Hypertension Treatment Prescription | 1678 Participants |
| Intervention Arm - Sustainment Phase | Hypertension Treatment Prescription | 177 Participants |
| Control Arm - Baseline Phase | Hypertension Treatment Prescription | 175 Participants |
| Control Arm - Intensive Implementation Phase | Hypertension Treatment Prescription | 1698 Participants |
| Control Arm - Sustainment Phase | Hypertension Treatment Prescription | 256 Participants |