Effect of RCT Testing on a CBPR-Developed Cessation Intervention for Culturally Diverse, Low Socioeconomic Women

Sunday, 30 July 2017: 3:30 PM

Jeannette Andrews, PhD, RN, FAAN1
Martina Mueller, PhD2
Susan Newman, PhD2
Gayenell S. Magwood, PhD3
Karen Kane McDonnell, PhD, MSN4
Janie Heath, PhD5
Martha S. Tingen, PhD6
(1)Nursing, University of South Carolina, Columbia, SC, SC, USA
(2)Medical University of South Carolina, Charleston, SC, USA
(3)College of Nursing, Medical University of South Carolina, Charleston, SC, USA
(4)College of Nursing, University of South Carolina, Columbia, SC, USA
(5)Nursing, University of Kentucky, xxx, KY, USA
(6)Medical College of Georgia, Georgia Prevention Institute, Augusta University, Augusta, GA, USA

Purpose:  There are an estimated 4.8 million households living in US government subsidized housing, with the majority of these households led by single African American women. The smoking prevalence of African American women in US subsidized housing neighborhoods is two to three times higher than the African American women in the general population (40-60 % vs. 19 %). The convergence of individual, social, and neighborhood factors for women in subsidized housing creates an environment in which smoking is a social norm.

The purpose of this presentation is three fold: 1) to describe the effect of a recently conducted, CBPR developed, multi-level smoking cessation intervention among African American women living in subsidized housing neighborhoods in the Southeastern US; 2) to compare the results of this randomized controlled trial (RCT) with previous pilot work with these underserved, high-risk communities; and, 3) to analyze the barriers and challenges of sustaining relationships and research efforts with culturally diverse, low-socioeconomic communities over 15 years, scaling up CBPR pilot studies to randomized controlled trials, and social and environmental barriers with communities burdened with fiscal, environmental and social inequities.

Methods: For the recently conducted RCT, a total of n = 409 women in 14 subsidized housing neighborhoods in two Southeastern US states were enrolled in a group randomized controlled trial. Government subsidized neighborhoods (e.g., public housing and Section 8) were included that had at least 100 households in a clustered site and that had not been used in previous studies. Of the 34 subsidized housing neighborhoods in these two regions, the study was implemented in the 14 neighborhoods that met eligibility. Seven matched pairs were formed of the 14 subsidized neighborhoods based on size and geographical location and randomly assigned one neighborhood in each pair to either the treatment condition (Sister to Sister) or a delayed control condition. Neighborhoods included in the study ranged in size from 100 to 352 households, with 27-32 participants enrolled in each neighborhood. Intervention neighborhoods received a 24-week multi-level intervention (AKA Sister to Sister).

Women in neighborhoods randomized to the Sister to Sister intervention received individual, peer group, and neighborhood level strategies. Individual-led strategies were led by paid community health workers (termed “coaches” in the field). The community health workers provided 1:1 contact with participants to reinforce educational content and behavioral strategies from the group sessions, social support with the quitting process, and enhanced self-efficacy with cessation attempts. The community health workers met with participants’ in their homes or a designated place in the neighborhood (i.e., community center) weekly for 12 weeks, every other week for 4 weeks, and every 4 weeks for 8 weeks. A certified smoking cessation counselor led behavioral group sessions in each intervention neighborhood using the Sister to Sister handbook based on the Public Health Service Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. An 8-week supply of transdermal nicotine patches were offered to participants who set a quit date (targeted at week 2 of the intervention) with weekly to bi-weekly supplies administered after the group sessions. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities, such as a memory walk for family members who died from smoking-related illnesses, neighborhood health fair, and/or neighborhood cookout with anti-tobacco educational handouts. Control neighborhoods received written cessation materials at weeks 1, 6, 12, 18 and a delayed intervention after the 12 month data collection. The primary outcome evaluated in the study was biochemically verified 7-day point prevalence abstinence from smoking assessed at 6 and 12 months.

For the longitudinal analyses, random coefficient models were used to account for the group-randomized trial design.

The previous pilot study conducted 6-8 years earlier, used a quasi-experimental design, with a similarly designed, multi-level intervention (AKA Sister to Sister). A total of 103 women from 2 neighborhoods completed this intervention study. Process evaluation, focus group data, and researcher/community feedback informed barriers and challenges and lessons learned over this 15 year period.

 Results: In both the RCT and the investigators' previous pilot work, recruitment and retention (> 90%) goals for participants were met. In the RCT, approximately 86 % of the sample were African American, 34 % had not completed high school or equivalency, and 78 % reported household incomes less than $20,000/year. At baseline, women, on average, smoked 12.7 cigarettes per day. Although 12 month smoking cessation outcomes in the RCT (12% vs. 5.3%, p=0.016; intervention vs. control) were similar to other biochemically validated outcome studies by other investigators in similar communities, the cessation outcomes were lower than the previous pilot study (39 % vs. 11.5 %, p=0.008; intervention vs. control) conducted by this investigative team. In both the pilot and RCT, intervention participants who kept community health worker visits, attended group sessions, and used nicotine patches were more likely to remain abstinent from smoking.

There were two major differences observed in the pilot and the larger, scaled RCT: time in the neighborhood and readiness of neighborhoods.

 Conclusion: A CBPR developed study with culturally diverse women in subsidized housing showed promise with recruitment and retention in a large randomized controlled trial. While the cessation outcomes were less promising than previous pilot studies conducted by our team, women made serious quit attempts, quit smoking and/or reduced daily smoking over the study period. This landmark study demonstrated the benefits of a CBPR approach to reach, recruit, and engage this highly vulnerable population, however, effectiveness in promoting lifestyle behavior change in environments burdened with poverty and social inequities remain a challenge. Investigators, community partners, and especially funders, must consider and ultimately support the time and resources necessary for the processes of building relationships, trust, and co-ownership with marginalized, culturally diverse groups. Further, as a society, addressing the social determinants of health continue to be a priority in promoting behavior change with these high-risk communities.