Combining community participatory research with a randomized clinical trial: The protecting the hood against tobacco (PHAT) smoking cessation study

• Published in: Heart & lung 2010, Vol.39 (1), p.50-63
• Main Authors: Froelicher, Erika Sivarajan, RN, MA, MPH, PhD, Doolan, Daniel, RN, PhD, Yerger, Valerie B., ND, McGruder, Carol O., BA, DEF, Malone, Ruth E., RN, PhD, FAAN
• Format: Article
• Language: English
• Subjects: Adult; Adults; African Americans; Cardiovascular; Clinical Nursing Research; Clinical trials; Community-Based Participatory Research; Critical Care; Female; Humans; Intervention; Male; Medically Underserved Area; Middle Aged; Outcome and Process Assessment (Health Care); Patient Education as Topic; Patient Selection; Poverty; Pulmonary/Respiratory; Smoking cessation; Smoking Cessation - ethnology; Social Justice; Studies; Tobacco; Urban Population
• ISSN: 0147-9563; 1527-3288
• DOI: 10.1016/j.hrtlng.2009.06.004

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.