Implementation Evaluation of a Combination Intervention for Sustainable Blood Pressure Control in Rural KwaZulu-Natal, South Africa DDI.AHRI.ImpactBP Nompumelelo Mkwanazi Africa Health Research Institute Nesstar Publisher Implementation Evaluation of a Combination Intervention for Sustainable Blood Pressure Control in Rural KwaZulu-Natal, South Africa AHRI.ImpactBP Mark J. Siedner Nombulelo Magula Thomas Gaziano

Kathy Baisley

Lusanda Mazibuko

Dickman Gareta

Siyabonga Nxumalo

Nsika Sithole

IMPACT-BP CHW Team

IMPACT-BP Clinical Team

Baptista Joao

Hosea Kambonde

Sindy Mthethwa

Thabang Manyaapelo

Shafika Abrahams-Gessel

Africa Health Research Institute Nesstar Publisher United States National Institutes of Health R01 HL144848 V1.0.0 Hypertension, blood pressure control, community-based intervention, digital health, eHealth, mHealth, community health workers, anti-hypertensive medication, task shifting, primary care, sub-Saharan Africa, South Africa, non-communicable diseases, health systems strengthening, randomized controlled trial, health services access, treatment outcomes Hypertension, Blood Pressure, Blood Pressure Determination, Antihypertensive Agents, Medication Adherence, Community Health Workers, Task Shifting, Telemedicine, mHealth, Patient Care Team, Primary Health Care, Health Services Accessibility, Randomized Controlled Trial, Longitudinal Studies, Treatment Outcome, South Africa South Africa Africa Health Research Institute (AHRI) demographic surveillance area in rural uMkhanyakude district, KwaZulu-Natal Individual-level longitudinal clinical trial data. Each record represents a single participant enrolled in the hypertension trial, with repeated measures of blood pressure, clinical assessments, medication use, and survey-based sociodemographic information collected across multiple study visits (enrolment, 6 months, and 12 months). Data are linked at the individual level using unique study identifiers. Adults aged =18 years residing in the catchment areas of Nkundusi and Madwaleni Primary Health Care Clinics in uMkhanyakude District (KwaZulu-Natal, South Africa), with uncontrolled blood pressure. Uncontrolled blood pressure was defined as a SBP > 140 mmHg or a diastolic BP > 90mm Hg with at least one prior elevated reading 6 months or more prior. Participants were screened, enrolled, and observed between 30 November 2022 and 30 June 2025. Survey Data, clinical data, biomarker data, administrative records data, spatial data Participants were recruited from the Nkundusi and Madwaleni primary health care clinics within the AHRI Health and Demographic Surveillance Site (HDSS). All adults presenting at the clinics for primary care during weekdays were screened for eligibility. Eligible participants were aged =18 years, resided in the clinic catchment area, had elevated blood pressure at screening (systolic >140 mmHg or diastolic >90 mmHg), and had at least one previous elevated blood pressure reading documented =6 months prior. Exclusion criteria included pregnancy, breastfeeding, symptomatic elevated blood pressure (>180/110 mmHg), advanced chronic kidney disease (glomerular filtration rate <60 ml/min/1.73m²), and use of =3 full-dose anti-hypertensive medications. Enrolled participants were randomized to one of three study arms (SOC, CHW, eCHW+) in blocks of 9, stratified by clinic and current use of anti-hypertensive therapy. Study data were entered into REDCap and underwent verification and cleaning prior to analysis. Blood pressure outcomes were averaged as specified, and missing values were identified for potential imputation. Randomisation and intervention adherence data were linked with outcome and covariate data. Data were de-identified prior to analysis. Quality control procedures included duplicate entry checks, automated range checks for blood pressure, and consistency checks across visits. AHRI.ImpactBP.Aim 2 Clinical Trial.2025.NSDstat 774 32 Nesstar 200801 Trial Unique Identifier 774 0 Sex 774 0 1 Male 186 2 Female 588 Screening Site 774 0 1 Nkundusi 451 2 Madwaleni 323 Age at screening (years) 774 0 90 90+ Are you taking any medications for your blood pressure? 774 0 0 No 23 1 Yes 751 SBP at baseline 774 0 94 219.5 146.95 17.2 1 dbp 774 0 64 131.5 90.918 10.458 SBP at 6 months 762 12 95 213.5 139.909 16.746 2 dbp 762 12 60.5 131 87.674 9.611 SBP at 12 months 754 20 84.5 203 137.68 15.125 3 dbp 754 20 49.5 117.5 86.64 9.459 First (out of 3) BP measurement at baseline 774 0 107 227 156.796 17.13 Body mass index (kg/m^2) 774 0 10.2 64.1 29.704 7.236 eGFR (ml/min/1.73m^2) 774 0 50 132 76.052 14.974 Randomised study arm 774 0 1 SOC 259 2 CBPM 257 3 eCBPM+ 258 Have internal running water in the household? 772 2 0 No 660 1 Yes 112 Sysmiss 2 Time to clinic 772 2 2 3000 46.595 111.877 Main mode of transport to clinic 772 2 0 Walk 338 1 Bus/taxi 401 2 Car 28 96 Other 5 Sysmiss 2 Cost to clinic (category/code) 434 340 0 No 21 1 Yes 413 2 Don't Know 0 Sysmiss 340 Money spent to get to clinic (in Rands) 413 361 10 200 28.68 23.372 Diabetic 772 2 0 No 667 1 Yes 105 Sysmiss 2 HIV co-infection 773 1 0 Negative 346 1 Positive 360 2 Not tested 67 Sysmiss 1 Age category 774 0 1 Under 45 57 2 45 - 59 256 3 60 or older 461 BMI category 774 0 1 Underweight 17 2 Normal 208 3 Overweight 198 4 Obese 351 HIV co-infection 773 1 0 Negative 413 1 Positive 360 2 Not tested 0 Sysmiss 1 Education level 773 1 0 None 303 1 Less or primary education 183 2 More than primary education 287 Sysmiss 1 Employment status 765 9 0 Not employed 678 1 Employed 87 Sysmiss 9 Asset Index Quintile (Deprivation) 765 9 1 Most Deprived 162 2 Deprived 147 3 Moderate 151 4 Less Deprived 153 5 Least Deprived 152 Sysmiss 9 SBP≥160 mmHg at enrolment 774 0 0 No 618 1 Yes 156 Age≥60 774 0 0 No 313 1 Yes 461 Change at 6 months 762 12 -75.5 55 -7.15 18.934 Change at 12 months 754 20 -85 45 -9.385 18.47