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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.

SUBMITTER: Chambers R

PROVIDER: S-EPMC4850664 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial.

Chambers Rachel R Tingey Lauren L Beach Anna A Barlow Allison A Rompalo Anne A

BMC public health 20160429

<h4>Background</h4>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 su ...[more]

PMID: 27129956

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Project description:BACKGROUND:Human immunodeficiency virus (HIV) disproportionately impacts minority youth. Interventions to decrease HIV sexual risk are needed. OBJECTIVE:We hypothesized that an engaging theory-based digital health intervention in the form of an interactive video game would improve sexual health outcomes in adolescents. METHODS:Participants aged 11 to 14 years from 12 community afterschool, school, and summer programs were randomized 1:1 to play up to 16 hours of an experimental video game or control video games over 6 weeks. Assessments were conducted at 6 weeks and at 3, 6, and 12 months. Primary outcome was delay of initiation of vaginal/anal intercourse. Secondary outcomes included sexual health attitudes, knowledge, and intentions. We examined outcomes by gender and age. RESULTS:A total of 333 participants were randomized to play the intervention (n=166) or control games (n=167): 295 (88.6%) were racial/ethnic minorities, 177 (53.2%) were boys, and the mean age was 12.9 (1.1) years. At 12 months, for the 258 (84.6%) participants with available data, 94.6% (122/129) in the intervention group versus 95.4% (123/129) in the control group delayed initiation of intercourse (relative risk=0.99, 95% CI 0.94-1.05, P=.77). Over 12 months, the intervention group demonstrated improved sexual health attitudes overall compared to the control group (least squares means [LS means] difference 0.37, 95% CI 0.01-0.72, P=.04). This improvement was observed in boys (LS means difference 0.67, P=.008), but not girls (LS means difference 0.06, P=.81), and in younger (LS means difference 0.71, P=.005), but not older participants (LS means difference 0.03, P=.92). The intervention group also demonstrated increased sexual health knowledge overall (LS means difference 1.13, 95% CI 0.64-1.61, P<.001), in girls (LS means difference 1.16, P=.001), boys (LS means difference 1.10, P=.001), younger (LS means difference 1.18, P=.001), and older (LS means difference=1.08, P=.002) participants. There were no differences in intentions to delay the initiation of intercourse between the two groups (LS means difference 0.10, P=.56). CONCLUSIONS:An interactive video game intervention improves sexual health attitudes and knowledge in minority adolescents for at least 12 months. TRIAL REGISTRATION:Clinicaltrials.gov NCT01666496; https://clinicaltrials.gov/ct2/show/NCT01666496 (Archived by WebCite at http://www.webcitation.org/6syumc9C0).

Project description:Helping the large number of problem drinkers who will never seek treatment is a challenging issue. Public health initiatives employing educational materials or mass media campaigns have met with mixed success. However, clinical research has developed effective brief interventions to help problem drinkers. This project will employ an intervention that has been validated in clinical settings and then modified into an ultra-brief format suitable for use as a public health intervention. The major objective of this study is to conduct a randomized controlled trial to establish the effectiveness of an ultra-brief, personalized feedback intervention for problem drinkers.Problem drinkers recruited on a baseline population telephone survey conducted in a major metropolitan city in Canada will be randomized to one of three conditions - a personalized feedback pamphlet condition, a control pamphlet condition, or a no intervention control condition. In the week after the baseline survey, households in the two pamphlet conditions will be sent their respective pamphlets. Changes in drinking will be assessed post intervention at three-month and six-month follow-ups. Drinking outcomes will be compared between experimental conditions using Structural Equation Modeling. The primary hypothesis is that problem drinkers from households who receive the personalized feedback pamphlet intervention will display significantly improved drinking outcomes at three and six-month follow-ups as compared to problem drinkers from households in the no intervention control condition. Secondary hypotheses will test the impact of the intervention on help seeking, and explore the mediating or moderating role of perceived drinking norms, perceived alcohol risks and the problem drinker's social reasons for drinking.This trial will provide information on the effectiveness of a pamphlet-based personalized feedback intervention for problem drinkers in a community setting.ClinicalTrials.gov registration #NCT00688584.

Dataset Information

Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial.

Publications

Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial.

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