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临床试验/NCT02116179
NCT02116179已完成不适用

DVD-based HIV/HCV Intervention for Drug-Involved Latino Criminal Justice Clients

University of Delaware2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
2
主要终点
Sexual risk behaviors

研究概览

简要总结

The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse treatment clients to either the experimental intervention or to a wait list control group; and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based intervention.

They study hypothesis are the following:

  1. participants in the intervention condition will report greater reductions in sexual risk behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared to the control group;
  2. participants will report greater reductions in drug risk behaviors (e.g., sharing injection equipment, drug use during sex) from baseline to 3 month follow-up compared to the control group;
  3. participants who report more HIV prevention information, motivation, and behavioral skills will report fewer sexual risk behaviors.

详细描述

The specific aims for Stage1b are: (1) to pilot test and evaluate the effectiveness of the DVD-based HIV intervention by recruiting 210 Latino offenders mandated to substance abuse treatment; and (2) to evaluate both participant and interventionist acceptability of this novel DVD intervention. Participants will be recruited from a local community agency that provides outpatient substance abuse treatment services for court-mandated individuals. Eligible participants will be self-identified Latino/Hispanic, between the ages of 18 and 49, heterosexual, and all participants will be involved with the criminal justice system. Participants will be randomized into either an intervention or a wait-list control condition. The intervention consists of one DVD-based group session facilitated by an interventionist. Sexual risk, drug use, mental health, and background information will be assessed at baseline, and again at 3 months after the intervention session. At the end of the intervention session, each participant will complete an acceptability questionnaire, and the interventionist will complete a checklist to assess treatment fidelity. It is hypothesized that both sexual risk and drug use behaviors will decrease between baseline and follow-up for the intervention group compared to the control group. The project is innovative because it will develop a DVD-based, culturally-appropriate and language specific, HIV/Hepatitis C virus prevention intervention for Latino offenders. The proposed research is significant, because it is expected to produce a brief HIV/Hepatitis C virus intervention that can be implemented within the criminal justice system and targets a high risk group.

It is hypothesized that participants in the intervention condition will report significant reductions in sexual risk behaviors (e.g., unprotected sexual contact) and drug risk behaviors (e.g. sharing injection equipment, drug use while having sex) from baseline to 3 - month follow-up when compared to control group. The main analysis here is to compare the proportion (or mean) of primary outcomes for those measured at 3-month (post-intervention) to those measured at baseline (pre-intervention) between the intervention and control group. The null is that there will be no differences, and alternative hypotheses would be that the intervention group will report more of a reduction in risk behaviors than control group. These hypotheses can be tested by either repeated-measures ANCOVA or regression with the robust cluster estimator obtained after controlling for intervention condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • must be between 18 - 49 years of age
  • self-identify as Hispanic or Latino
  • be involved in the criminal justice system
  • report a history of drug use
  • be in an outpatient substance abuse program
  • self-identify as heterosexual

排除标准

  • be HIV positive
  • be cognitively impaired

结局指标

主要结局

Sexual risk behaviors

时间窗: 90 days

次要结局

  • Drug Use Behaviors(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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