Evidence map›Paper›PMID 37308076›Full record

ArticleContemporary clinical trials2023

Protocol: Implementation evaluation of a combination intervention for sustainable blood pressure control in rural KwaZulu-Natal, South Africa (IMPACT BP): A three-arm, unblinded, parallel group individually randomized clinical trial.

Nsika Sithole, Alison Castle, Siyabonga Nxumalo, Lusanda Mazibuko, Thabang Manyaapelo, Shafika Abrahams-Gessel, Siphephelo Dlamini, Dickman Gareta, Joanna Orne-Gliemann, Kathy Baisley and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05492955 (Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05492955 nacompletednot on this map

Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)

TypeinterventionalSponsorBrigham and Women's HospitalRan2022 to 2025Enrolled774ConditionsHypertensionArmsCommunity Health Worker Care Model, Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model, Standard of Care Model
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Home-Based Care for Hypertension in Rural South Africa.The New England journal of medicine · 2025
    Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 4 countries.

Nsika SitholeAfrica Health Research Institute, KwaZulu-Natal, South Africa. Electronic address: Nsika.sithole@ahri.org.
Alison CastleAfrica Health Research Institute, KwaZulu-Natal, South Africa; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.
Siyabonga NxumaloAfrica Health Research Institute, KwaZulu-Natal, South Africa.
Lusanda MazibukoAfrica Health Research Institute, KwaZulu-Natal, South Africa.
Thabang ManyaapeloAfrica Health Research Institute, KwaZulu-Natal, South Africa.
Shafika Abrahams-GesselHarvard TH Chan School of Public Health, Boston, MA, United States of America.
Siphephelo DlaminiAfrica Health Research Institute, KwaZulu-Natal, South Africa.
Dickman GaretaAfrica Health Research Institute, KwaZulu-Natal, South Africa.
Joanna Orne-GliemannUniversity of Bordeaux, National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, Bordeaux, France.
Kathy BaisleyAfrica Health Research Institute, KwaZulu-Natal, South Africa; Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Max BachmannNorwich Medical School, University of East Anglia, Norwich, United Kingdom.
Nombulelo MagulaDivision of Internal Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
Thomas A GazianoDivision of Cardiology, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard TH Chan School of Public Health, Boston, MA, United States of America.
Mark J SiednerAfrica Health Research Institute, KwaZulu-Natal, South Africa; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Division of Internal Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
Africa Health Research Institute · ZAHarvard University · USInstitut de Recherche pour le Développement · FRMassachusetts General Hospital · USUniversity of East Anglia · GBUniversity of KwaZulu-Natal · ZA

Funding

Partnership for Global Health Research Training Program (Renewal)-Supplement for OBSSR, NCI, NCI-AIDS and NIDCDD43TW010543 · FIC · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Wafaie W Fawzi, DAVIDSON HOWES HAMER · 2017 to 2026
$12.1M
PROGRAM FOR AIDS CLINICAL RESEARCH TRAINING (PACRT)T32AI007433 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI MARK J SIEDNER · 1992 to 2026
$11.4M
Implementation of a Combination Intervention for Sustainable Blood Pressure Control in Rural KwaZulu-Natal, South Africa (IMPACT-BP)R01HL144848 · NHLBI · KWAZULU-NATAL RESEARCH INSTITUTE TB-HIV · PI GAZIANO, THOMAS A, SIEDNER, MARK J · 2020 to 2024
$2.9M
Mentoring patient-oriented research to improve cardiovascular health among people with HIV in sub-Saharan AfricaK24HL166024 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI MARK J SIEDNER · 2022 to 2026
$616k
FIC NIH HHS D43 TW010543NHLBI NIH HHS K24 HL166024NHLBI NIH HHS R01 HL144848NIAID NIH HHS T32 AI007433Wellcome Trust
6 · The paper itself

Abstract

backgroundHypertension is the primary risk factor for stroke and heart disease, which are leading causes of death in South Africa. Despite the availability of treatments, there is an implementation gap in how best to deliver hypertension care in this resource-limited region.

methodsWe describe a three-arm parallel group individually randomized control trial to evaluate the effectiveness and implementation of a technology-supported, community-based intervention to improve blood pressure control among people with hypertension in rural KwaZulu-Natal. The study will compare three strategies: 1) standard of care (SOC arm) clinic-based management, 2) home-based blood pressure management supported by community blood pressure monitors (CBPM arm) and a mobile health application to record blood pressure readings and enable clinic-based nurses to remotely manage care, and 3) an identical strategy to the CBPM arm, except that participants will use a cellular blood pressure cuff, which automatically transmits completed readings over cellular networks directly to clinic-based nurses (eCBPM+ arm). The primary effectiveness outcome is change in blood pressure from enrollment to 6 months. The secondary effectiveness outcome is the proportion of participants with blood pressure control at 6 months. Acceptability, fidelity, sustainability, and cost-effectiveness of the interventions will also be assessed.

conclusionsIn this protocol, we report the development of interventions in partnership with the South Africa Department of Health, a description of the technology-enhanced interventions, and details of the study design so that our intervention and evaluation can inform similar efforts in rural, resource-limited settings. PROTOCOL: Version 3 November 9th, 2022. CLINICALTRIALS: gov Trial Registration: NCT05492955 SAHPRA Trial Number: N20211201. SANCTR Number: DOH-27-112,022-4895.

Indexed as

HypertensionBlood PressureBlood Pressure DeterminationHumansRandomized Controlled Trials as TopicRisk FactorsSouth AfricaCommunity healthcare workersDigital applicationHypertensionSouth Africa

Identifiers

PMID37308076
PMCPMC10527603
OpenAlexW4380182404

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.