title: Adherence and retention in clinical trials: a community-based approach.
abstract: BACKGROUND
  The Community Health Advisor (CHA) model has been widely used to recruit rural and low-income, mostly African American women into clinical and behavioral research studies. However, little is known about its effectiveness in promoting retention and adherence of such women in clinical trials.
  
  
  METHODS
  The Community-Based Retention Intervention Study evaluated the effectiveness of a community-based intervention strategy using the CHA model and the empowerment theory to improve the retention and adherence of minority and low-income women in clinical trials. The research strategy included the training and use of the volunteer CHAs as research partners. The target population included women participating in the University of Alabama at Birmingham clinical site of the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), a multicenter, randomized clinical trial. Two communities in Jefferson County, Alabama, that were matched according to population demographics were identified and randomly assigned to either an intervention group or a control group. Thirty community volunteers were recruited to be CHAs and to implement the intervention with the ALTS trial participants. In total, 632 ALTS participants agreed to participate in the project, including 359 in the intervention group, which received CHA care, and 273 in the control group, which received standard care.
  
  
  RESULTS
  Adherence rates for scheduled clinic visits were significantly higher in the intervention group (80%) compared with the control group (65%; P < .0001).
  
  
  CONCLUSIONS
  The results indicate that volunteer CHAs can be trained to serve as research partners and can be effective in improving the retention and adherence of minority and low-income women in clinical trials.
authors.affiliation: Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Mona N
authors.initials: MN
authors.lastname: Fouad
authors.forename: Rhoda E
authors.initials: RE
authors.lastname: Johnson
authors.forename: M Christine
authors.initials: MC
authors.lastname: Nagy
authors.forename: Sharina D
authors.initials: SD
authors.lastname: Person
authors.forename: Edward E
authors.initials: EE
authors.lastname: Partridge
mesh_terms: D001741:Black or African American; D000407:Alabama; D003153:Community Health Services / Q000379:methods*; D003625:Data Collection; D005260:Female; D006297:Health Services Accessibility; D006758:Hospital Volunteers; D006801:Humans; D008913:Minority Groups; D018307:Neoplasms, Squamous Cell / Q000473:pathology / Q000628:therapy*; D010349:Patient Compliance; D010353:Patient Education as Topic; D062526:Patient Navigation; D018579:Patient Selection; D011203:Poverty; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012959:Socioeconomic Factors; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000628:therapy*; D014838:Volunteers; D035862:Vulnerable Populations; D000078329:Workforce
keywords: African American women; adherence; clinical trials; minority women; retention; underserved women