Combining community participatory research with a randomized clinical trial: The protecting the hood against tobacco (PHAT) smoking cessation study
published online 23 July 2009.
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≥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.
aDepartment of Physiological Nursing, School of Nursing, University of California, San Francisco, California
bDepartment of Epidemiology and Biostatistics, School of Medicine, University of California, San Francisco, California
cSan Francisco University, San Francisco, California
dDepartment of Social and Behavioral Sciences, School of Nursing, University of California, San Francisco, California
ePolaris Research and Development and San Francisco African American Tobacco Free Project, San Francisco, California
fInstitute for Health Policy Studies, School of Medicine, University of California, San Francisco, California
Corresponding author: Erika Froelicher, RN, MA, MPH, PhD, Department of Physiological Nursing, 2 Koret Way, Room N631, University of California San Francisco, San Francisco, CA 94143-0610.
This study was supported by funding from the California Tobacco-Related Disease Research Program (grants 11BT-1701 and 12AT-1700).
ABSTRACT