title: Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial.
abstract: American Indian adults are more likely to experience co-occurring mental health and substance use disorders than adults of other racial/ethnic groups and are disproportionately burdened by the most common sexually transmitted infections, namely chlamydia and gonorrhea. Several behavioral interventions are proven efficacious in lowering risk for sexually transmitted infection in various populations and, if adapted to address barriers experienced by American Indian adults who suffer from mental health and substance use problems, may be useful for dissemination in American Indian communities. The proposed study aims to examine the efficacy of an adapted evidence-based intervention to increase condom use and decrease sexual risk-taking and substance use among American Indian adults living in a reservation-based community in the Southwestern United States.
  
  
  
  The proposed study is a randomized controlled trial to test the efficacy of an adapted evidence-based intervention compared to a control condition. Participants will be American Indian adults ages 18-49 years old who had a recent episode of binge substance use and/or suicide ideation. Participants will be randomized to the intervention, a two-session risk-reduction counseling intervention or the control condition, optimized standard care. All participants will be offered a self-administered sexually transmitted infection test. Participants will complete assessments at baseline, 3 and 6 months follow-up. The primary outcome measure is condom use at last sex.
  
  
  
  This is one of the first randomized controlled trials to assess the efficacy of an adapted evidence-based intervention for reducing sexual risk behaviors among AI adults with substance use and mental health problems. If proven successful, there will be an efficacious program for reducing risk behaviors among high-risk adults that can be disseminated in American Indian communities as well as other rural and under-resourced health systems.
  
  
  
  Clinical Trials NCT02513225.
authors.affiliation: Johns Hopkins Center for American Indian Health, Johns Hopkins University, 415 North Washington Street Suite 400, Baltimore, Maryland, 21224, USA. rstrom3@jhu.edu.
authors.forename: Rachel
authors.initials: R
authors.lastname: Chambers
authors.affiliation: Johns Hopkins Center for American Indian Health, Johns Hopkins University, 415 North Washington Street Suite 400, Baltimore, Maryland, 21224, USA.
authors.forename: Lauren
authors.initials: L
authors.lastname: Tingey
authors.affiliation: Johns Hopkins Center for American Indian Health, Johns Hopkins University, 415 North Washington Street Suite 400, Baltimore, Maryland, 21224, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Beach
authors.affiliation: Johns Hopkins Center for American Indian Health, Johns Hopkins University, 415 North Washington Street Suite 400, Baltimore, Maryland, 21224, USA.
authors.forename: Allison
authors.initials: A
authors.lastname: Barlow
authors.affiliation: Johns Hopkins School of Medicine, Johns Hopkins University, 415 North Washington Street Suite 400, Baltimore, Maryland, 21224, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Rompalo
mesh_terms: D000293:Adolescent; D000328:Adult; D001521:Behavior Therapy / Q000379:methods*; D002690:Chlamydia Infections / Q000208:ethnology / Q000517:prevention & control; D002985:Clinical Protocols; D017280:Condoms / Q000706:statistics & numerical data; D003376:Counseling; D005260:Female; D006069:Gonorrhea / Q000208:ethnology / Q000517:prevention & control; D015658:HIV Infections / Q000208:ethnology / Q000517:prevention & control; D006293:Health Promotion; D006801:Humans; D007198:Indians, North American; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D012107:Research Design; D012306:Risk; D012309:Risk-Taking; D012725:Sexual Behavior; D012749:Sexually Transmitted Diseases / Q000208:ethnology / Q000517:prevention & control*; D015206:Southwestern United States / Q000208:ethnology; D019966:Substance-Related Disorders / Q000150:complications / Q000628:therapy; D055815:Young Adult
keywords: American Indian; Counseling; Prevention; Risk-reduction; Sexually transmitted infection; Substance use; Suicide ideation