跳至主要内容
临床试验/NCT00643305
NCT00643305已完成2 期

HIV Prevention With 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: 2006年2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
HIV-related knowledge, as measured by the HIV Knowledge Questionnaire (HIV-KQ)

研究概览

简要总结

The purpose of this study is to determine whether motivational interviewing and skills building interventions reduce HIV risk behavior for adults with serious and persistent mental illness.

详细描述

Our long-term objective is to reduce the incidence of HIV for people with serious and persistent mental illness (SMI) by developing an effective primary and secondary HIV risk reduction intervention for this population which can be easily delivered in the "real world" settings in which patients routinely receive care. Research findings document that the incidence of HIV infection, sexually transmitted diseases, and sexual and drug use behaviors are high among people with serious mental illness, as evidenced by rates of HIV infection and other sexually-transmitted diseases (STDs). A variety of factors underlie risky behaviors for the SMI, including cognitive impairment, poor judgment, affective instability and impulsiveness.

Skills-building (SB) HIV risk reduction interventions, typically delivered in a small group formats, have had modest success in increasing HIV-related knowledge and improving risk reduction skills for people with SMI, although these effects are transient. As skills-building interventions are currently the standard of care in most research and clinical settings for HIV prevention, it is important to identify new ways to augment these interventions.

A relatively new and promising addition to the armamentarium of individualized interventions is Motivational Interviewing (MI). MI is an approach designed to reduce ambivalence and enhance intrinsic motivation to change problematic behaviors. Previous researchers have noted effects for both SB and MI interventions independently, however, these effects tend to be fairly modest. Integrating these approaches in a systematized way allows us to test the degree to which this combination is useful, given that both motivation and skills are clearly important in effecting health behavior change.

Our specific primary aims are the following:

  1. To adapt SB and MI interventions for HIV risk reduction for men and women with serious and persistent mental illness (SMI).

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
Single (Outcomes Assessor)

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

  • Age 19 and older
  • Able to provide consent
  • Able to understand and speak English
  • Willing and able to participate
  • Suffer from a serious and persistent mental illness (SMI)
  • Have had at least one HIV risk behavior (unprotected sexual activity, sharing injection drug needles without following Center for Disease Control guidelines for needle-cleaning, sexual activity while under the influence of drugs or alcohol) during the three-month period prior to the baseline evaluation

排除标准

  • Do not suffer from a serious mental illness
  • Have not engaged in an HIV risk behavior during the three-month period prior to the baseline evaluation.
  • Unable to provide consent
  • Unable to understand and speak English
  • Under the age of 19

结局指标

主要结局

HIV-related knowledge, as measured by the HIV Knowledge Questionnaire (HIV-KQ)

时间窗: 6 months

Accessing HIV counseling and testing, assessed by self-report

时间窗: 6 months

Self-reported reduction in HIV risk behavior for infection/re-infection of HIV, as measured by administration of the TimeLine Follow-Back.

时间窗: 6 months

Skillfulness in behaviors critical for efficacious use of HIV risk reduction strategies, measured by standardized role-plays and demonstrations

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验