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临床试验/NCT01689545
NCT01689545已完成不适用

Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 2,175 人开始时间: 2007年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,175
试验地点
1
主要终点
HIV injecting risk behavior

研究概览

简要总结

The purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among HIV positive injecting drug users.

详细描述

This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention consists of a two-tiered approach that addresses structural and individual level barriers to risk reduction: 1) The structural level of the intervention consists of community-based programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive individuals; 2) The individual level of the intervention consists of 2 HIV posttest counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research questions for the overall project are:

  1. What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs?
  2. What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors
  3. Are combined individual and structural level interventions more effective in reducing injecting and sexual behaviors among HIV-positive IDUs than individual or structural interventions alone and more effective than the standard HIV VCT?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • laboratory confirmed HIV positive diagnosis
  • able and wiling to bring an injecting network member for screening
  • injected drugs in previous 6 months
  • planned residence in Thai Nguyen for next 24 months

排除标准

  • unwilling to provide locator information
  • unable to participate in group counseling sessions due to psychological disturbance, cognitive impairment or threatening behavior
  • currently participating in other HIV or drug use intervention activities
  • Network member participant
  • Inclusion Criteria:
  • laboratory confirmed HIV negative diagnosis
  • injected or shared drug paraphernalia in past 6 months
  • interacts at least once a week with index participant
  • Exclusion Criteria:
  • unwilling to provide locator information
  • having psychological or cognitive impairment
  • currently participating in other HIV intervention

研究组 & 干预措施

Individual level

Experimental

干预措施: Individual level (Behavioral)

Combined individual & structural level

Experimental

干预措施: Structural level (Behavioral)

Standard of Care

Active Comparator

干预措施: Individual level standard of care (Behavioral)

Individual level

Experimental

干预措施: Structural level standard of care (Behavioral)

Structural level

Experimental

干预措施: Structural level (Behavioral)

Structural level

Experimental

干预措施: Individual level standard of care (Behavioral)

Combined individual & structural level

Experimental

干预措施: Individual level (Behavioral)

Standard of Care

Active Comparator

干预措施: Structural level standard of care (Behavioral)

结局指标

主要结局

HIV injecting risk behavior

时间窗: 2 years

Change in self-reported use of new injecting equipment

HIV sexual risk behavior

时间窗: 2 years

Change in self-reported condom use during sexual intercourse

次要结局

  • HIV incidence(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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