title: A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial.
abstract: BACKGROUND
  Black men have the greatest burden of premature death and disability from hypertension (HTN) in the United States, and the highest incidence and mortality from colorectal cancer (CRC). While several clinical trials have reported beneficial effects of lifestyle changes on blood pressure (BP) reduction, and improved CRC screening with patient navigation (PN), the effectiveness of these approaches in community-based settings remains understudied, particularly among Black men.
  
  
  METHODS
  MISTER B is a two-parallel-arm randomized controlled trial that will compare the effect of a motivational interviewing tailored lifestyle intervention (MINT) versus a culturally targeted PN intervention on improvement of BP and CRC screening among black men aged ≥50 with uncontrolled HTN who are eligible for CRC screening. Approximately 480 self-identified black men will be randomly assigned to one of the two study conditions. This innovative research design allows each intervention to serve as the control for the other. Specifically, the MINT arm is the control condition for the PN arm, and vice-versa. This novel, simultaneous testing of two community-based interventions in a randomized fashion is an economical and yet rigorous strategy that also enhances the acceptability of the project. Participants will be recruited during scheduled screening events at barbershops in New York City. Trained research assistants will conduct the lifestyle intervention, while trained community health workers will deliver the PN intervention. The primary outcomes will be 1) within-patient change in systolic and diastolic BP from baseline to six months and 2) CRC screening rates at six months.
  
  
  CONCLUSIONS
  This innovative study will provide a unique opportunity to test two interventions for two health disparities simultaneously in community-based settings. Our study is one of the first to test culturally targeted patient navigation for CRC screening among black men in barbershops. Thus, our study has the potential to improve the reach of hypertension control and cancer prevention efforts within a high-risk population that is under-represented in primary care settings.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01092078.
authors.affiliation: Center for Healthful Behavior Change, New York University School of Medicine, 227 E, 30th St,, 6th Floor, Room 637, New York, NY 10016, USA. Joseph.ravenell@nyumc.org.
authors.forename: Joseph
authors.initials: J
authors.lastname: Ravenell
authors.forename: Hayley
authors.initials: H
authors.lastname: Thompson
authors.forename: Helen
authors.initials: H
authors.lastname: Cole
authors.forename: Jordan
authors.initials: J
authors.lastname: Plumhoff
authors.forename: Gia
authors.initials: G
authors.lastname: Cobb
authors.forename: Lola
authors.initials: L
authors.lastname: Afolabi
authors.forename: Carla
authors.initials: C
authors.lastname: Boutin-Foster
authors.forename: Martin
authors.initials: M
authors.lastname: Wells
authors.forename: Marian
authors.initials: M
authors.lastname: Scott
authors.forename: Gbenga
authors.initials: G
authors.lastname: Ogedegbe
mesh_terms: D001741:Black or African American / Q000523:psychology*; D000367:Age Factors; D001461:Barbering; D001794:Blood Pressure; D002985:Clinical Protocols; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000208:ethnology / Q000517:prevention & control* / Q000523:psychology; D003153:Community Health Services; D003466:Cultural Characteristics; D055088:Early Detection of Cancer; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology*; D006293:Health Promotion; D054624:Health Status Disparities; D054625:Healthcare Disparities / Q000208:ethnology; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000208:ethnology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D062405:Motivational Interviewing; D009519:New York City; D062526:Patient Navigation; D018579:Patient Selection; D011237:Predictive Value of Tests; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome