Trial Outcomes & Findings for Systems Analysis and Improvement Approach for the Hypertension Care Cascade (NCT NCT04088656)
NCT ID: NCT04088656
Last Updated: 2024-11-27
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
Results posted on
2024-11-27
Participant Flow
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.
Unit of analysis: health facilities
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Baseline Period
STARTED
|
12307 8
|
10042 8
|
|
Baseline Period
Patients
|
12307 8
|
10042 8
|
|
Baseline Period
COMPLETED
|
12307 8
|
10042 8
|
|
Baseline Period
NOT COMPLETED
|
0 0
|
0 0
|
|
Intensive Implementation Period
STARTED
|
20788 8
|
17909 8
|
|
Intensive Implementation Period
Healthcare Workers
|
171 8
|
0 0
|
|
Intensive Implementation Period
Patients
|
20617 8
|
17909 8
|
|
Intensive Implementation Period
COMPLETED
|
20788 8
|
17909 8
|
|
Intensive Implementation Period
NOT COMPLETED
|
0 0
|
0 0
|
|
Sustainment Implementation Period
STARTED
|
2317 8
|
2567 8
|
|
Sustainment Implementation Period
Healthcare Workers
|
134 8
|
0 0
|
|
Sustainment Implementation Period
Patients
|
2183 8
|
2567 8
|
|
Sustainment Implementation Period
COMPLETED
|
2317 8
|
2567 8
|
|
Sustainment Implementation Period
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Hypertension Systems Analysis and Improvement
n=35412 Participants
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.
|
Control
n=30518 Participants
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.
|
Total
n=65930 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Healthcare Workers · <=18 years
|
0 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=305 Participants • 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.
|
|
Age, Categorical
Healthcare Workers · Between 18 and 65 years
|
305 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
305 Participants
n=305 Participants • 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.
|
|
Age, Categorical
Healthcare Workers · >=65 years
|
0 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=305 Participants • 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.
|
|
Age, Categorical
Patients · <=18 years
|
0 Participants
n=34141 Participants • 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.
|
0 Participants
n=30466 Participants • 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.
|
0 Participants
n=64607 Participants • 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.
|
|
Age, Categorical
Patients · Between 18 and 65 years
|
33465 Participants
n=34141 Participants • 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.
|
29871 Participants
n=30466 Participants • 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.
|
63336 Participants
n=64607 Participants • 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.
|
|
Age, Categorical
Patients · >=65 years
|
676 Participants
n=34141 Participants • 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.
|
595 Participants
n=30466 Participants • 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.
|
1271 Participants
n=64607 Participants • 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.
|
|
Sex: Female, Male
Healthcare Workers · Female
|
132 Participants
n=284 Participants • 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.
|
0 Participants
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.
|
132 Participants
n=284 Participants • 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.
|
|
Sex: Female, Male
Healthcare Workers · Male
|
152 Participants
n=284 Participants • 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.
|
0 Participants
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.
|
152 Participants
n=284 Participants • 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.
|
|
Sex: Female, Male
Patients · Female
|
22718 Participants
n=35079 Participants • 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.
|
18821 Participants
n=30508 Participants • 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.
|
41539 Participants
n=65587 Participants • 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.
|
|
Sex: Female, Male
Patients · Male
|
12361 Participants
n=35079 Participants • 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.
|
11687 Participants
n=30508 Participants • 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.
|
24048 Participants
n=65587 Participants • 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.
|
|
Race (NIH/OMB)
Healthcare Workers · American Indian or Alaska Native
|
0 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=305 Participants • 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.
|
|
Race (NIH/OMB)
Healthcare Workers · Asian
|
0 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=305 Participants • 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.
|
|
Race (NIH/OMB)
Healthcare Workers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=305 Participants • 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.
|
|
Race (NIH/OMB)
Healthcare Workers · Black or African American
|
305 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
305 Participants
n=305 Participants • 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.
|
|
Race (NIH/OMB)
Healthcare Workers · White
|
0 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=305 Participants • 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.
|
|
Race (NIH/OMB)
Healthcare Workers · More than one race
|
0 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=305 Participants • 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.
|
|
Race (NIH/OMB)
Healthcare Workers · Unknown or Not Reported
|
0 Participants
n=305 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=305 Participants • 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.
|
|
Race (NIH/OMB)
Patients · American Indian or Alaska Native
|
0 Participants
n=35107 Participants • 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.
|
0 Participants
n=30518 Participants • 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.
|
0 Participants
n=65625 Participants • 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.
|
|
Race (NIH/OMB)
Patients · Asian
|
0 Participants
n=35107 Participants • 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.
|
0 Participants
n=30518 Participants • 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.
|
0 Participants
n=65625 Participants • 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.
|
|
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35107 Participants • 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.
|
0 Participants
n=30518 Participants • 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.
|
0 Participants
n=65625 Participants • 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.
|
|
Race (NIH/OMB)
Patients · Black or African American
|
35107 Participants
n=35107 Participants • 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.
|
30518 Participants
n=30518 Participants • 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.
|
65625 Participants
n=65625 Participants • 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.
|
|
Race (NIH/OMB)
Patients · White
|
0 Participants
n=35107 Participants • 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.
|
0 Participants
n=30518 Participants • 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.
|
0 Participants
n=65625 Participants • 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.
|
|
Race (NIH/OMB)
Patients · More than one race
|
0 Participants
n=35107 Participants • 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.
|
0 Participants
n=30518 Participants • 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.
|
0 Participants
n=65625 Participants • 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.
|
|
Race (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=35107 Participants • 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.
|
0 Participants
n=30518 Participants • 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.
|
0 Participants
n=65625 Participants • 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.
|
|
Region of Enrollment
Mozambique
|
35412 Healthcare workers and Patients
n=35412 Participants
|
30518 Healthcare workers and Patients
n=30518 Participants
|
65930 Healthcare workers and Patients
n=65930 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Intervention Arm - Baseline Phase
n=74 Participants
Newly eligible HIV-infected patients attending intervention facilities during baseline phase
|
Intervention Arm - Intensive Implementation Phase
n=1447 Participants
Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase
|
Intervention Arm - Sustainment Phase
n=157 Participants
Newly eligible HIV-infected patients attending intervention facilities during sustainment phase
|
Control Arm - Baseline Phase
n=52 Participants
Newly eligible HIV-infected patients attending control facilities during baseline phase
|
Control Arm - Intensive Implementation Phase
n=1430 Participants
Newly eligible HIV-infected patients attending control facilities during intensive implementation phase
|
Control Arm - Sustainment Phase
n=161 Participants
Newly eligible HIV-infected patients attending control facilities during sustainment phase
|
|---|---|---|---|---|---|---|
|
Controlled Hypertension
|
3 Participants
|
315 Participants
|
37 Participants
|
1 Participants
|
82 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 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
The proportion of HIV-infected patients who were screened for hypertension
Outcome measures
| Measure |
Intervention Arm - Baseline Phase
n=12307 Participants
Newly eligible HIV-infected patients attending intervention facilities during baseline phase
|
Intervention Arm - Intensive Implementation Phase
n=20617 Participants
Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase
|
Intervention Arm - Sustainment Phase
n=2183 Participants
Newly eligible HIV-infected patients attending intervention facilities during sustainment phase
|
Control Arm - Baseline Phase
n=10042 Participants
Newly eligible HIV-infected patients attending control facilities during baseline phase
|
Control Arm - Intensive Implementation Phase
n=17909 Participants
Newly eligible HIV-infected patients attending control facilities during intensive implementation phase
|
Control Arm - Sustainment Phase
n=2567 Participants
Newly eligible HIV-infected patients attending control facilities during sustainment phase
|
|---|---|---|---|---|---|---|
|
Blood Pressure Screening
|
4275 Participants
|
20359 Participants
|
2182 Participants
|
3351 Participants
|
17882 Participants
|
2556 Participants
|
SECONDARY outcome
Timeframe: 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
The proportion of HIV-infected patients diagnosed with hypertension among those who were screened
Outcome measures
| Measure |
Intervention Arm - Baseline Phase
n=4275 Participants
Newly eligible HIV-infected patients attending intervention facilities during baseline phase
|
Intervention Arm - Intensive Implementation Phase
n=20359 Participants
Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase
|
Intervention Arm - Sustainment Phase
n=2182 Participants
Newly eligible HIV-infected patients attending intervention facilities during sustainment phase
|
Control Arm - Baseline Phase
n=3351 Participants
Newly eligible HIV-infected patients attending control facilities during baseline phase
|
Control Arm - Intensive Implementation Phase
n=17882 Participants
Newly eligible HIV-infected patients attending control facilities during intensive implementation phase
|
Control Arm - Sustainment Phase
n=2556 Participants
Newly eligible HIV-infected patients attending control facilities during sustainment phase
|
|---|---|---|---|---|---|---|
|
Hypertension Diagnosis
|
318 Participants
|
2247 Participants
|
244 Participants
|
288 Participants
|
2442 Participants
|
404 Participants
|
SECONDARY outcome
Timeframe: 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)
The proportion of hypertension medication-eligible HIV patients receiving a prescription
Outcome measures
| Measure |
Intervention Arm - Baseline Phase
n=318 Participants
Newly eligible HIV-infected patients attending intervention facilities during baseline phase
|
Intervention Arm - Intensive Implementation Phase
n=2247 Participants
Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase
|
Intervention Arm - Sustainment Phase
n=244 Participants
Newly eligible HIV-infected patients attending intervention facilities during sustainment phase
|
Control Arm - Baseline Phase
n=288 Participants
Newly eligible HIV-infected patients attending control facilities during baseline phase
|
Control Arm - Intensive Implementation Phase
n=2442 Participants
Newly eligible HIV-infected patients attending control facilities during intensive implementation phase
|
Control Arm - Sustainment Phase
n=404 Participants
Newly eligible HIV-infected patients attending control facilities during sustainment phase
|
|---|---|---|---|---|---|---|
|
Hypertension Treatment Prescription
|
221 Participants
|
1678 Participants
|
177 Participants
|
175 Participants
|
1698 Participants
|
256 Participants
|
SECONDARY outcome
Timeframe: 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
The proportion of HIV patients who are hypertension medication-eligible and pick up their medications after receiving a prescription
Outcome measures
| Measure |
Intervention Arm - Baseline Phase
n=221 Participants
Newly eligible HIV-infected patients attending intervention facilities during baseline phase
|
Intervention Arm - Intensive Implementation Phase
n=1678 Participants
Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase
|
Intervention Arm - Sustainment Phase
n=177 Participants
Newly eligible HIV-infected patients attending intervention facilities during sustainment phase
|
Control Arm - Baseline Phase
n=175 Participants
Newly eligible HIV-infected patients attending control facilities during baseline phase
|
Control Arm - Intensive Implementation Phase
n=1698 Participants
Newly eligible HIV-infected patients attending control facilities during intensive implementation phase
|
Control Arm - Sustainment Phase
n=256 Participants
Newly eligible HIV-infected patients attending control facilities during sustainment phase
|
|---|---|---|---|---|---|---|
|
Hypertension Medication Pick up
|
74 Participants
|
1447 Participants
|
157 Participants
|
52 Participants
|
1430 Participants
|
161 Participants
|
Adverse Events
Hypertension Systems Analysis and Improvement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place