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临床试验/NCT00218335
NCT00218335已完成2 期

A Network & Dyad HIV Prevention Intervention for IDU's

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 1,024 人开始时间: 2003年6月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
1,024
试验地点
1
主要终点
Any Sex Risk

研究概览

简要总结

The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners.

详细描述

HIV seroincidence among injection drug users remains high, with unprotected sexual contact substantially contributing to new HIV infections among injection drug users (IDUs). Interventions that are culturally competent and target drug users' main sex and drug partners may be especially effective for HIV/STI and HCV control and prevention.

The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. Furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.

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 (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (i)Self reported injection drug use within the prior 6 months; (ii)Willingness to invite a risk network member into the study and to talk about HIV prevention; (iii)Age 18 or older

排除标准

  • Not concurrently enrolled in another HIV prevention intervention

研究组 & 干预措施

Intervention Condition

Experimental

Participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.

干预措施: Intervention Condition (Behavioral)

Control Condition

Active Comparator

The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.

干预措施: Control Condition (Behavioral)

结局指标

主要结局

Any Sex Risk

时间窗: 6 months

Talked About HIV-related Topics With Drug Buddies (in the Past Month)

时间窗: 12 months

Showed a Needleless Syringe to Drug Buddies

时间窗: 18 months

Talked About Responding to Overdose to Drug Buddies

时间窗: 6 months

Any Injection Risk (Monthly Versus Never)

时间窗: 18 months

Number of Needle or Cooker Sharers (2 or More Versus None)

时间窗: 18 months

Shared Cooker When Preparing Drugs

时间窗: 18 months

Injecting Drugs

时间窗: 18 months

Talked About HIV-related Topics With Drug Buddies (in Past Month)

时间窗: 18 months

Talked About Hepatitis to Drug Buddies

时间窗: 18 months

Talked About HIV-related Topics With Drug Buddies (in the Past Month)

时间窗: 6 months

Showed a Needleless Syringe to Drug Buddies

时间窗: 6 months

Any Injection Risk (Monthly Versus Never)

时间窗: 12 months

Number of Needle or Cooker Sharers (2 or More Versus None)

时间窗: 12 months

Showed a Needleless Syringe to Drug Buddies

时间窗: 12 months

次要结局

未报告次要终点

研究者

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

Carl Latkin

Professor

Johns Hopkins Bloomberg School of Public Health

研究点 (1)

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