Combining community participatory research with a randomized clinical trial: The protecting the hood against tobacco (PHAT) smoking cessation study
Froelicher, Erika Sivarajan
Yerger, Valerie B.
McGruder, Carol O.
Malone, Ruth E.
Froelicher, Erika Sivarajan and Doolan, Daniel and Yerger, Valerie B. and McGruder, Carol O. and Malone, Ruth E. (2010) Combining community participatory research with a randomized clinical trial: The protecting the hood against tobacco (PHAT) smoking cessation study. Heart & Lung: The Journal of Acute and Critical Care, 39 (1). pp. 50-63.
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BACKGROUND: This article describes the process and results of a smoking cessation intervention randomized clinical trial (RCT) that was conducted as a community-based participatory research project. This RCT tested whether outcomes are improved by adding social justice and tobacco industry targeting messages to a smoking cessation program conducted among African American adults within a low-income community in San Francisco, California. This study provides lessons for future similar research projects that focus on urban low-income populations. METHODS: Participants were randomly allocated to receive a smoking-cessation program (control group [CG]) or CG care plus tobacco industry and media (IAM) messages. Primary interventions were behavioral. At intake, participants reporting severe withdrawal or smoking > or = 25 cigarettes daily were offered free nicotine replacement therapy. Baseline data were from an in-person interview. Outcome measures included self-reported smoking status; validation of quitting was by salivary cotinine assays. RESULTS: Of 87 participants providing baseline data, 31% (27) did not join the RCT. Proportions quitting in the CG and IAM group were 11.5% and 13.6% at 6 months and 5.3% and 15.8% at 12 months, respectively. CONCLUSION: African Americans in underserved inner-city neighborhoods can be recruited into RCTs with community participatory approaches. Differences between the CG and IAM in proportions who quit were 2.1% and 10.5% at 6 and 12 months, respectively. More than 3 years with adequate funding, high staffing ratios, and intense outreach and follow-up schedules are needed to achieve recruitment and study goals.