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.


CONCLUSIONS
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.
Froelicher
Erika Sivarajan
ES
Department of Physiological Nursing, School of Nursing, University of California, San Francisco, California 94143-0610, USA.
Doolan
Daniel
D
Yerger
Valerie B
VB
McGruder
Carol O
CO
Malone
Ruth E
RE
D000328:Adult; D001741:Black or African American; D015400:Clinical Nursing Research; D055812:Community-Based Participatory Research; D005260:Female; D006801:Humans; D008297:Male; D008507:Medically Underserved Area; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D010353:Patient Education as Topic; D018579:Patient Selection; D011203:Poverty; D016540:Smoking Cessation / Q000208:ethnology*; D012935:Social Justice; D014505:Urban Population