Combining community participatory research with a randomized clinical trial: the Protecting the Hood Against Tobacco (PHAT) smoking cessation study.

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. 2010 Elsevier Inc. All rights reserved.

RCT Entities:   Population Interventions Outcomes