Rationale and design of a study to test the effectiveness of a combined community health worker and text messaging-based intervention for smoking cessation in India (Project MUKTI).

Abstract

Nearly 275 million individuals in India consume tobacco every day, with more than 1 million dying annually as a result. Few people in India have access to smoking cessation services, an essential component of combating tobacco use globally. We hypothesize that a strategy of systematic community health worker (CHW) based counseling that covers eligible people who smoke in a geographical area, combined with text messaging support, will result in improved quit rates. The study is a cluster randomized controlled trial that will be conducted at 2 sites in India. Sixteen clusters will be randomized into either an intervention or control arm. A total of 560 smokers between the age of 18 and 70 will be recruited from their home through CHWs. Smokers at all stages of change will be offered the intervention, which is based on the transtheoretical model of change. Pre-contemplative participants will be offered health education and motivational interviewing through CHWs. They will also be offered a low frequency form of text messaging, focused on health education and the benefits of quitting. Participants who are actively contemplating quitting smoking will be offered a more intensive intervention, with more frequent visits by CHWs and more intensive text messaging support. Contemplative participants will be encouraged to set a quit date, and all participants will be assessed periodically for stage of change to provide the appropriate intervention. Participants who set a quit date will be encouraged to use NRT to help with quitting. Control group participants are provided with brief smoking cessation advice only, at the start of the trial. The primary outcome will be self-reported abstinence for the past 14 days, biochemically verified by exhaled CO levels (cut-off 10 ppm) assessed at the end of 1 year of the intervention. We will test whether a CHW-based intervention that incorporates motivational interviewing, text messaging and supportive counseling can prove effective in systematically helping smokers quit.