Development and Evaluation of a Package to Improve Hypertension Control in Nigeria [DEPIHCON]: a Cluster-randomized Controlled Trial

Background: Nigeria's healthcare system capacity to stem the increasing trend in hypertension is limited in coverage, scope and manpower. Use of trained community-based care providers demonstrated to be an effective complement in improving access to, and supporting healthcare delivery has not been adequately examined for hypertension care in Nigeria. This study is proposed to evaluate the effectiveness of using trained community-oriented resource persons (CORPs) to improve hypertension control in Nigeria.

Methods: An intervention study will be conducted in three states using a mixed method design. First is a baseline survey using a semi-structured pre-tested questionnaire to collect information on demographics, clinical data, knowledge, occurrence and risk factors of hypertension among 1704 adults ≥18 years. Focus group discussions (FGD) and key informant interviews (KII) will be conducted to explore a community's experience of hypertension, challenges with hypertension management and support required to improve control in 10 selected communities in each state. The second is a cluster-randomized controlled trial to evaluate effect of a package on reduction of blood pressure (BP) and prevention of cardiovascular (CVD) risk factors among 200 hypertensive patients to be followed up in intervention and control arms over a 6-month period in each state. The package will include trained CORPs conducting community-based screening of BP and referral, diagnosis confirmation and initial treatment in the health facility, followed by monthly home-based follow-up care and provision of health education on hypertension control and healthy lifestyle enhanced by phone voice message reminders. In the control arm, the usual care (diagnosis, treatment and follow-up care in hospital of a patient's choice) will continue. Third, an endline survey will be conducted in both intervention and control communities to evaluate changes in mean BP, control, knowledge and proportion of other CVD risk factors. In addition, FGD and KII will be used to assess participants' perceived quality and acceptability of the interventions as delivered by CORPs.

Discussion: This research is expected to create awareness, improve knowledge, perception, behaviours, attitude and practices that will reduce hypertension in Nigeria. Advocacy for buy-in and scale up of using CORPs in hypertension care by the government is key if found to be effective.

Trial Registration: PACTR Registry PACTR202107530985857 . Registered on 26 July 2021.