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临床试验/NCT00356291
NCT00356291已完成2 期

HIV Prevention for the Mentally Ill: Motivation-Skills

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
53
试验地点
2
主要终点
Communication and negotiation skills

研究概览

简要总结

This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.

详细描述

People with serious mental illness (SMI) are at higher risk for contracting HIV than the general population. Although fewer people with SMI are sexually active, as compared to the healthy population, those with SMI who are sexually active tend to engage in sexual behaviors that put them at increased risk for HIV and other STDs. The onset of SMI, which often interferes with normal psychosocial development, may cause these behaviors. Additionally, SMI is frequently associated with poor judgment, affective instability, and impulsiveness. Interventions designed to reduce the risk for contracting HIV in people with SMI exist, but they have had little success. New approaches to treating this population are essential. This study will evaluate the effectiveness of motivational interviewing (MI) plus skill building (SB) exercises in reducing HIV risk behavior in people with SMI.

Participants in this 6-month, open-label study are randomly assigned to partake in SB training either alone or combined with MI. The skill building program focuses on behavioral skills training, with an emphasis on negotiating and communicating with prospective partners. Training includes information about HIV risk, including mechanisms of transmission, abstinence, and safer sex and drug use behaviors; HIV risk reduction strategies, including condom use, abstinence/safer sex negotiation skills, and reduced/safer drug use; and an opportunity to be tested for HIV if the participant has not already done so. The SB plus MI intervention (SB-MI) includes components of the SB intervention, as well as elements of MI. MI includes identifying high risk sexual and drug use behaviors related to HIV; reducing the ambivalence about making high risk behavior changes; increasing motivation to change high risk behaviors; and developing a plan to implement these changes. HIV testing may be included. Participants in both interventions report to the study site on six to seven occasions over the course of the study. The visits last between 1 and 2 hours and include both treatment and evaluation. Participants attend two follow-up visits, one 3 months after randomization, and one 6 months after randomization.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meets criteria for a serious and persistent mental illness (as defined by the Massachusetts Department of Mental Health)
  • English-speaking
  • Engagement in HIV risk behavior within 3 months prior to study entry
  • Ability to keep study-related appointments

排除标准

  • Unstable mental status

结局指标

主要结局

Communication and negotiation skills

时间窗: Measured at Months 3 and 6

Timeline Followback (TLFB) measures of HIV risk behaviors and use of HIV risk prevention strategies (including use of male and female condoms, dental dams, and recommended intravenous needle-cleaning)

时间窗: Measured at Months 3 and 6

Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning

时间窗: Measured at Months 3 and 6

Access of HIV counseling and testing

时间窗: Measured at Months 3 and 6

次要结局

  • HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)(Measured at Months 3 and 6)
  • Multidimensional Condom Attitude Scale (MCAS)(Measured at Months 3 and 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Brady

Director, Mental Health Counseling & Behavioral Medicine Program Associate Professor of Psychiatry Boston University School of Medicine

Boston Medical Center

研究点 (2)

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