title: Improving access to medicines for non-communicable diseases in rural India: a mixed methods study protocol using quasi-experimental design.
abstract: India has the distinction of financing its healthcare mainly through out-of-pocket expenses by individual families contributing to catastrophic health expenditure and impoverishment. Nearly 70 % of the expenditure is on medicines purchased at private pharmacies. Patients with chronic ailments are especially affected, as they often need lifelong medicines. Over the past years in India, there have been several efforts to improve drug availability at government primary health centres. In this study, we aim to understand health system factors that affect utilisation and access to generic medicines for people with non-communicable diseases.
  
  
  
  This study aims to understand if (and how) a package of interventions targeting primary health centres and community participation platforms affect utilisation and access to generic medicines for people with non-communicable diseases in the current district context in India. This study will employ a quasi-experimental design and a qualitative theory-driven approach. PHCs will be randomly assigned to one of three arms of the intervention. In one arm, PHCs will receive inputs to optimise service delivery for non-communicable diseases, while the second arm will receive an additional package of interventions to strengthen community participation platforms for improving non-communicable disease care. The third arm will be the control. We will conduct household and facility surveys, before and after the intervention and will estimate the effect of the intervention by difference-in-difference analysis. Sample size for measuring effects was calculated based on obtaining at least 30 households for each primary health centre spread across three distance-based clusters. Primary outcomes include availability and utilisation of medicines at primary health centres and out-of-pocket expenditure for medicines by non-communicable disease households. Focus group discussions with patients and in-depth interviews with health workers will also be conducted. Qualitative and process documentation data will be used to explain how the intervention could have worked.
  
  
  
  By taking into consideration several health system building blocks and trying to understand how they interact, our study aims to generate evidence for health planners on how to optimise health services to improve access to medicines.
  
  
  
  Protocol registered on Clinical Trials Registry of India with registration identifier number CTRI/2015/03/005640 on 17(th) March 2015.
authors.affiliation: Institute of Public Health, 250, 2 c main, 2 c cross, Girinagar I phase, Bangalore, 560 085, Karnataka, India. prashanthns@iphindia.org.
authors.forename: N S
authors.initials: NS
authors.lastname: Prashanth
authors.affiliation: Institute of Public Health, 250, 2 c main, 2 c cross, Girinagar I phase, Bangalore, 560 085, Karnataka, India.
authors.forename: Maya Annie
authors.initials: MA
authors.lastname: Elias
authors.affiliation: Institute of Public Health, 250, 2 c main, 2 c cross, Girinagar I phase, Bangalore, 560 085, Karnataka, India.
authors.forename: Manoj Kumar
authors.initials: MK
authors.lastname: Pati
authors.affiliation: Institute of Public Health, 250, 2 c main, 2 c cross, Girinagar I phase, Bangalore, 560 085, Karnataka, India.
authors.forename: Praveenkumar
authors.initials: P
authors.lastname: Aivalli
authors.affiliation: Institute of Public Health, 250, 2 c main, 2 c cross, Girinagar I phase, Bangalore, 560 085, Karnataka, India.
authors.forename: C M
authors.initials: CM
authors.lastname: Munegowda
authors.affiliation: Institute of Public Health, 250, 2 c main, 2 c cross, Girinagar I phase, Bangalore, 560 085, Karnataka, India.
authors.forename: Srinath
authors.initials: S
authors.lastname: Bhanuprakash
authors.affiliation: Karnataka Health Systems Resource Centre, Leprosy hospital campus, Magadi Road, 1st cross, Bangalore, 560023, Karnataka, India.
authors.forename: S M
authors.initials: SM
authors.lastname: Sadhana
authors.affiliation: Institute of Tropical Medicine, Nationalestraat - 155, 2000, Antwerp, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Criel
authors.affiliation: Alliance for Health Policy and Systems Research, World Health Organisation, Geneva, Switzerland.
authors.forename: Maryam
authors.initials: M
authors.lastname: Bigdeli
authors.affiliation: Institute of Public Health, 250, 2 c main, 2 c cross, Girinagar I phase, Bangalore, 560 085, Karnataka, India.
authors.forename: Narayanan
authors.initials: N
authors.lastname: Devadasan
mesh_terms: D002908:Chronic Disease / Q000188:drug therapy*; D003256:Community Participation; D017144:Focus Groups; D019538:Health Care Surveys; D006297:Health Services Accessibility; D006801:Humans; D007194:India; D004364:Pharmaceutical Preparations / Q000600:supply & distribution*; D011320:Primary Health Care; D012107:Research Design; D019035:Rural Health Services
chemical_list: D004364:Pharmaceutical Preparations
keywords: Access to medicines; Health systems research; Non-communicable diseases; Out-of-pocket expenditure on medicines