Open Access Open Badges Study protocol

Optimizing linkage and retention to hypertension care in rural Kenya (LARK hypertension study): study protocol for a randomized controlled trial

Rajesh Vedanthan1*, Jemima H Kamano2, Violet Naanyu3, Allison K Delong4, Martin C Were5, Eric A Finkelstein6, Diana Menya7, Constantine O Akwanalo8, Gerald S Bloomfield9, Cynthia A Binanay9, Eric J Velazquez9, Joseph W Hogan4, Carol R Horowitz1, Thomas S Inui5, Sylvester Kimaiyo8 and Valentin Fuster110

Author Affiliations

1 Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, 10029 New York, USA

2 Department of Medicine, Moi Teaching and Referral Hospital, Nandi Road, P.O. Box 3-30100, Eldoret, Kenya

3 Department of Behavioural Sciences, School of Medicine, Moi University College of Health Sciences

4 Department of Biostatistics and Center for Statistical Sciences, Brown University, 121 South Main Street, 02903 Providence, Rhode Island, USA

5 Department of Medicine and Regenstrief Institute, Inc, Indiana University School of Medicine, 410 W. 10th Street, 46202 Indianapolis, Indiana, USA

6 Global Health Institute, Duke University, 310 Trent Drive Durham North Carolina 27710, USA

7 Department of Epidemiology & Nutrition, School of Public Health, Moi University, P.O. Box 3-30100 Eldoret, Kenya

8 Department of Medicine, Moi University College of Health Sciences, P.O. Box 3-30100 Eldoret, Kenya

9 Clinical Research Institute, Duke University, 2400 Pratt Street, DUMC 3850, 27705 Durham, North Carolina, USA

10 Centro Nacional de Investigaciones Cardiovasculares, 28029 Madrid, Spain

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Trials 2014, 15:143  doi:10.1186/1745-6215-15-143

Published: 27 April 2014



Hypertension is the leading global risk factor for mortality. Hypertension treatment and control rates are low worldwide, and delays in seeking care are associated with increased mortality. Thus, a critical component of hypertension management is to optimize linkage and retention to care.


This study investigates whether community health workers, equipped with a tailored behavioral communication strategy and smartphone technology, can increase linkage and retention of hypertensive individuals to a hypertension care program and significantly reduce blood pressure among them. The study will be conducted in the Kosirai and Turbo Divisions of western Kenya. An initial phase of qualitative inquiry will assess facilitators and barriers of linkage and retention to care using a modified Health Belief Model as a conceptual framework. Subsequently, we will conduct a cluster randomized controlled trial with three arms: 1) usual care (community health workers with the standard level of hypertension care training); 2) community health workers with an additional tailored behavioral communication strategy; and 3) community health workers with a tailored behavioral communication strategy who are also equipped with smartphone technology. The co-primary outcome measures are: 1) linkage to hypertension care, and 2) one-year change in systolic blood pressure among hypertensive individuals. Cost-effectiveness analysis will be conducted in terms of costs per unit decrease in blood pressure and costs per disability-adjusted life year gained.


This study will provide evidence regarding the effectiveness and cost-effectiveness of strategies to optimize linkage and retention to hypertension care that can be applicable to non-communicable disease management in low- and middle-income countries.

Trial registration

This trial is registered with (NCT01844596) on 30 April 2013.

Hypertension; Linkage to care; Retention in care; Community health workers; Tailored behavioral communication; Smartphone technology; Cost-effectiveness