) Despite Federal recommendations highlighting the need to include minorities and women in clinical research, recruitment and retention of these groups present a great challenge to researchers. There is a great need for effective interventions that address possible barriers related to recruitment and poor compliance with study protocols and to optimize minority and low-income women participation and retention in clinical research. This proposed study, """"""""Community Strategy to Retain Women Enrolled in Research"""""""" will evaluate the efficacy of a community-based intervention to enhance minority and low-income women retention and compliance in research trials. First, the study will evaluate communities' attitudes, health beliefs and knowledge toward clinical research and establish collaboration of community leaders. Secondly, a peer-support intervention will be designed based on the Lay Health Advisors (LHAS) and Community Health Advisor Network (CHAN) models using community resources to enhance women retention and compliance. The target population will be women in the Randomized Trial On Clinical Management of ASCUS and LSIL of Uterine Cervix Birmingham Clinical Center (ALTS). The study phases include: phase I - develop and test surveys and focus group questions. Phase II - administer surveys and key informant interviews to community leaders and conduct focus groups with women in Jefferson County, AL,. Phase III - intervention-testing phase which matches and randomizes two communities to either intervention or control. Volunteers in the intervention community will be identified and trained as LHAS; and intervention will be implemented. Phase IV - data analysis and report preparation. Study outcomes include: 1) attendance at ALTS follow-up visits; 2) scheduled appointment keeping; 3) community changes in knowledge, attitude and beliefs; 4) cost effectiveness of intervention strategy. This project will build on the CHAN and LHAs models. If successful, this community-based intervention strategy will be capable of developing a lasting partnership and grassroots network between communities and research institutions for future investigations.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
Project #
Application #
Study Section
Special Emphasis Panel (SRC (04))
Program Officer
Simpson, Nancy K
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Project End
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Fiscal Year
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University of Alabama Birmingham
Internal Medicine/Medicine
Schools of Medicine
United States
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Fouad, Mona N; Johnson, Rhoda E; Nagy, M Christine et al. (2014) Adherence and retention in clinical trials: a community-based approach. Cancer 120 Suppl 7:1106-12
Johnson, Rhoda E; Williams, Roma D; Nagy, M Christine et al. (2003) Retention of under-served women in clinical trials: a focus group study. Ethn Dis 13:268-78
Brown, D R; Fouad, M N; Basen-Engquist, K et al. (2000) Recruitment and retention of minority women in cancer screening, prevention, and treatment trials. Ann Epidemiol 10:S13-21