The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial.
BACKGROUND
South Africa has a high and rising prevalence of hypertension. Many affected individuals are not using medication, and few have controlled blood pressure. Until recently, primary care clinics focused on maternal and child health and management of acute conditions, but new government initiatives have shifted the focus to chronic diseases, including HIV/AIDS and hypertension.


METHODS
The Nkateko trial will test the effectiveness of clinic-based lay health workers (LHWs) in supporting hypertension management. It is a pragmatic, cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa, and it is underpinned by long-term health and demographic surveillance. Eight primary care facilities, with their catchment communities, are randomised to usual care or the addition of LHWs focused on chronic care. All clinics (intervention and control) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records. Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions, particularly hypertension. The LHWs will be supported by an implementation manager, who will work with clinic staff to develop the most effective role for the LHWs. Control clinics will continue to provide usual care. The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease. A process evaluation will be based on a realist approach using patient exit interviews, clinic observations and interviews with health professionals, LHWs and patients to document the intervention and its implementation.


CONCLUSIONS
There are challenges in the design of this trial. Assessing change through population surveys may reduce measurable effects; however, we feel this is appropriate because we aim to attract those who currently do not use clinics, and we hope to improve care for clinic users. Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community. We are constantly working to achieve an effective balance between the intervention and process evaluations.


BACKGROUND
ISRCTN12128227 (registered 5 March 2014).
Division of Health Sciences, Warwick Medical School, University of Warwick, Gibett Hill Road, Coventry CV4 7AL, UK. m.thorogood@warwick.ac.uk.
Margaret
M
Thorogood
Jane
J
Goudge
Melanie
M
Bertram
Tobias
T
Chirwa
Sandra
S
Eldridge
Francesc Xavier
FX
Gómez-Olivé
Felix
F
Limbani
Eustasius
E
Musenge
Nokuzola
N
Myakayaka
Stephen
S
Tollman
Rhian
R
Twine
D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D002391:Catchment Area, Health; D002985:Clinical Protocols; D003153:Community Health Services; D003695:Delivery of Health Care; D006302:Health Services Research; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D010043:Outcome and Process Assessment, Health Care; D010348:Patient Care Team; D010349:Patient Compliance; D011320:Primary Health Care; D012107:Research Design; D012307:Risk Factors; D019035:Rural Health Services; D013019:South Africa / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
D000959:Antihypertensive Agents