HypertensionIMPACT-BPNCT05492955
Implementation of a Combination Intervention for Sustainable Blood Pressure Control
A study testing Community Health Worker Care Model and Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model in people with Hypertension, run by Brigham and Women's Hospital at 1 site in South Africa.
Trial summary
This is a randomized clinical trial intended to identify the optimal strategy of blood pressure management in rural South Africa using Community Health Workers (CHWs) in conjunction with in-home BP monitoring among adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Community Health Worker Care Model and Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteSouth Africa
- Study dates
- 30 Nov 2022to 17 Jul 2025
- 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
- Age greater than 18 years old
- Residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW.
- Elevated blood pressure (blood pressure > 140/90 mmHg) on two measurements.
Who cannot join
- Pregnant or breast-feeding women.
- Severe, symptomatic hypertension with a measured blood pressure > 180/110 mmHg.
- Known, advanced chronic kidney disease. GFR < 60 ml/min/1.73 m2.
- Current use of at least 3 different anti-hypertensive therapies at full dose.
- Planning to move within the next 24 months.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Africa Health Research Institute (AHRI)
Mtubatuba, KwaZulu-Natal
About this study
Official title: Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)
This is a randomized clinical trial intended to identify the optimal strategy of blood pressure management in rural South Africa using Community Health Workers (CHWs) in conjunction with in-home BP monitoring among adults.
Read the detailed description
We will conduct a trial using CHWs in conjunction with in-home BP monitoring among 774 adults ≥ 18 years old residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW. Eligible participants will be recruited from prior community-based hypertension screening programs, CHW-led hypertension screening activities, and/or from trial clinics where they are accessing care. Consenting participants will be randomized to one of the three study arms of hypertension care (258 participants per arm): 1) clinic-based standard of care model (SOC); 2) community health worker-based blood pressure monitoring model (CHW); 3) and enhanced community health worker-based model, including mobile health blood pressure monitoring model (eCHW+). Independent of clinical care, all participants will be seen at enrollment and at 6 months for BP monitoring and data collection by study nurses for outcome assessments. The primary effectiveness outcome will be assessed in an intention-to-treat analysis and defined as the change in systolic blood pressure (SBP) 6 months after enrollment. The secondary effectiveness outcome will be the proportion of participants with controlled blood pressure, as defined by an SBP <140 mmHg and a diastolic BP (DBP) <90 mmHg 6 months after enrollment.
- Conditions
- Hypertension
- Being tested
- Community Health Worker Care Model, Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model, Standard of Care Model
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker Care ModelBehavioural
Also called CHW Model
Participants will be given a digital BP Cuff and a standardized training on its operation, and assigned a CHW from their local Community Health Team. The participant will be instructed to take 6-10 measurements BP per week and record them in a logbook. CHWs will return to participant homes every 2-4 weeks to collect BP measurements and enter them into a data collection system, assess for symptoms, and discuss treatment adherence and lifestyle recommendations. BP readings will be brought by the CHW to their assigned nursing supervisors at their local clinic, who will initiate and tailor medications based on a standardized clinical decision support algorithm, based on SA DoH hypertension control guidelines. All treatment decisions will be made by the nursing supervisors. Participants will either obtain medication(s) at the pharmacy or, as possible, have them delivered by a CHW.
Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring ModelBehavioural
Also called eCHW+ Model
Participants in this arm will also be given a BP Cuff, (but with cellular network capability, such that BP data can be directly transmitted to trial server), given training on its operation, and assigned a CHW from their local Community Health Team. The participant will be instructed to take 6-10 measurements BP per week, which will be automatically uploaded onto the server to be made available by the nurse supervisors. CHWs will return to participant homes every 2-4 weeks to ensure functionality of the devices and transmission, collect BP measurements if the system is not functional, assess for symptoms, and discuss treatment adherence and lifestyle recommendations. Nursing supervisors at the clinic will use the remotely collected BP data to initiate and tailor medications based on the same standardized clinical decision support (CDS) algorithm, based on SA DoH hypertension control guidelines. All treatment decisions will be made by the nursing supervisors.
Standard of Care ModelBehavioural
Also called SOC Model
Participants in the SOC arm will be referred to their clinic for active care as per standard clinical protocols. All care will be provided at the clinic. Routine care consists of regular visits to the clinic until BP is under control (<140/90 mmHg) and then at 6 monthly intervals. BP measurements to guide management decisions will be made at the clinic using standard clinic equipment. Symptoms related to hypertension and/or medications will be assessed at each visit. Medications available will include medications on the South African Essential Drug list and which are available in the pharmacy. Prescriptions are picked up at the clinic pharmacy by patients as per routine protocol at the clinics. CHWs may also conduct monitoring as guided by clinical guidelines and as advised by their clinical supervisors during the study period to assess for adherence and provide education.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Participants will receive clinic-based standard of care Receives: Behavioral: Standard of Care Model |
| Community Health Worker Care Model (CHW) | Experimental | Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery. Receives: Behavioral: Community Health Worker Care Model |
| Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+) | Experimental | Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery. Receives: Behavioral: Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Systolic Blood Pressure (SBP) Change
Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.
Measured: 6 months
Secondary outcomes (1)
Percentage of Participants With Blood Pressure Control (%)
Percentage of participants in each of the three study arms who had achieved blood pressure (BP) control.
BP control is defined the percentage of participants who have a measured BPe <140/90 mmHg, among the total number of participants, in each respective study arm, as measured at 6 months after enrollment.
The percentages reported are model-based estimated probabilities rather than raw observed proportions, and estimated using logistic regression, adjusted for the randomisation strata and baseline antihypertensive medication use. Arm-specific probabilities were obtained using marginal standardisation, yielding predicted probabilities from the fitted model, averaged over the covariate distribution of the analysis population, rather than counts divided by the number of participants arm. Estimates are thus continuous quantities not constrained to correspond exactly to whole numbers (e.g., 0.768 × 257 ≈ 197.4 participants), which is expected and statistically appropriate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start30 Nov 2022
- Primary completion18 Dec 2024
- Study completion17 Jul 2025
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 (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas A Gaziano, Brigham and Women's Hospital
- Investigators
- Thomas A Gaziano, MD, MSc, Principal investigator, Massachusetts General HospitalMark J Siedner, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492955
- Sponsor's protocol ID
- 2021P003469
- Acronym
- IMPACT-BP
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2022
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study, in compliance with guidance by the study funders (U.S. National Institutes of Health), study data will be fully de-identified and posted to a public data repository where it may be shared with other scientists for secondary use.
Publications
Siedner MJ, Magula N, Mazibuko L, Sithole N, Castle A, Nxumalo S, Manyaapelo T, Abrahams-Gessel S, Gareta D, Orne-Gliemann J, Baisley K, Bachmann M, Gaziano TA. Home-Based Care for Hypertension in Rural South Africa. N Engl J Med. 2025 Oct 2;393(13):1304-1314. doi: 10.1056/NEJMoa2509958. Epub 2025 Sep 1.
PubMed 40888742
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)
- ClinicalTrials.gov ID
- NCT05492955
- Acronym / sponsor ID
- IMPACT-BP / 2021P003469
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial intended to identify the optimal strategy of blood pressure management in rural South Africa using Community Health Workers (CHWs) in conjunction with in-home BP monitoring among adults.
Detailed description
We will conduct a trial using CHWs in conjunction with in-home BP monitoring among 774 adults ≥ 18 years old residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW. Eligible participants will be recruited from prior community-based hypertension screening programs, CHW-led hypertension screening activities, and/or from trial clinics where they are accessing care. Consenting participants will be randomized to one of the three study arms of hypertension care (258 participants per arm): 1) clinic-based standard of care model (SOC); 2) community health worker-based blood pressure monitoring model (CHW); 3) and enhanced community health worker-based model, including mobile health blood pressure monitoring model (eCHW+). Independent of clinical care, all participants will be seen at enrollment and at 6 months for BP monitoring and data collection by study nurses for outcome assessments. The primary effectiveness outcome will be assessed in an intention-to-treat analysis and defined as the change in systolic blood pressure (SBP) 6 months after enrollment. The secondary effectiveness outcome will be the proportion of participants with controlled blood pressure, as defined by an SBP <140 mmHg and a diastolic BP (DBP) <90 mmHg 6 months after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Behavioral: Standard of Care ModelParticipants will receive clinic-based standard of care |
| Community Health Worker Care Model (CHW) | Experimental | Behavioral: Community Health Worker Care ModelParticipants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery. |
| Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+) | Experimental | Behavioral: Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring ModelParticipants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years old
- Residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW.
- Elevated blood pressure (blood pressure > 140/90 mmHg) on two measurements.
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding women.
- Severe, symptomatic hypertension with a measured blood pressure > 180/110 mmHg.
- Known, advanced chronic kidney disease. GFR < 60 ml/min/1.73 m2.
- Current use of at least 3 different anti-hypertensive therapies at full dose.
- Planning to move within the next 24 months.
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 |
|---|---|---|
| Community Health Worker Care ModelAlso: CHW ModelParticipants will be given a digital BP Cuff and a standardized training on its operation, and assigned a CHW from their local Community Health Team. The participant will be instructed to take 6-10 measurements BP per week and record them in a logbook. CHWs will return to participant homes every 2-4 weeks to collect BP measurements and enter them into a data collection system, assess for symptoms, and discuss treatment adherence and lifestyle recommendations. BP readings will be brought by the CHW to their assigned nursing supervisors at their local clinic, who will initiate and tailor medications based on a standardized clinical decision support algorithm, based on SA DoH hypertension control guidelines. All treatment decisions will be made by the nursing supervisors. Participants will either obtain medication(s) at the pharmacy or, as possible, have them delivered by a CHW. | Behavioural | Community Health Worker Care Model (CHW) |
| Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring ModelAlso: eCHW+ ModelParticipants in this arm will also be given a BP Cuff, (but with cellular network capability, such that BP data can be directly transmitted to trial server), given training on its operation, and assigned a CHW from their local Community Health Team. The participant will be instructed to take 6-10 measurements BP per week, which will be automatically uploaded onto the server to be made available by the nurse supervisors. CHWs will return to participant homes every 2-4 weeks to ensure functionality of the devices and transmission, collect BP measurements if the system is not functional, assess for symptoms, and discuss treatment adherence and lifestyle recommendations. Nursing supervisors at the clinic will use the remotely collected BP data to initiate and tailor medications based on the same standardized clinical decision support (CDS) algorithm, based on SA DoH hypertension control guidelines. All treatment decisions will be made by the nursing supervisors. | Behavioural | Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+) |
| Standard of Care ModelAlso: SOC ModelParticipants in the SOC arm will be referred to their clinic for active care as per standard clinical protocols. All care will be provided at the clinic. Routine care consists of regular visits to the clinic until BP is under control (<140/90 mmHg) and then at 6 monthly intervals. BP measurements to guide management decisions will be made at the clinic using standard clinic equipment. Symptoms related to hypertension and/or medications will be assessed at each visit. Medications available will include medications on the South African Essential Drug list and which are available in the pharmacy. Prescriptions are picked up at the clinic pharmacy by patients as per routine protocol at the clinics. CHWs may also conduct monitoring as guided by clinical guidelines and as advised by their clinical supervisors during the study period to assess for adherence and provide education. | Behavioural | Standard of Care (SOC) |
Primary outcome
Mean Systolic Blood Pressure (SBP) Change
Time frame: 6 months
Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.
1 secondary outcome
Percentage of Participants With Blood Pressure Control (%)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40888742Siedner MJ, Magula N, Mazibuko L, Sithole N, Castle A, Nxumalo S, Manyaapelo T, Abrahams-Gessel S, Gareta D, Orne-Gliemann J, Baisley K, Bachmann M, Gaziano TA. Home-Based Care for Hypertension in Rural South Africa. N Engl J Med. 2025 Oct 2;393(13):1304-1314. doi: 10.1056/NEJMoa2509958. Epub 2025 Sep 1.
- Individual participant dataSharing planned: Yes. Upon completion of the study, in compliance with guidance by the study funders (U.S. National Institutes of Health), study data will be fully de-identified and posted to a public data repository where it may be shared with other scientists for secondary use.
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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.
Thomas A Gaziano, MD, MSc principal investigator
Massachusetts General Hospital
Mark J Siedner, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Care Model and Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model in people with Hypertension, run by Brigham and Women's Hospital at 1 site in South Africa.
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 3 inclusion and 5 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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 12 Mar 2026). 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?
Mean Systolic Blood Pressure (SBP) Change (time frame: 6 months). 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 NCT05492955, which also lists 1 linked publication.
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 12 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.