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临床试验/NCT01170741
NCT01170741已完成1 期

A Tailored Cue Card HIV/STI Intervention for High Risk Groups Pilot Study

RTI International2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
122
试验地点
2
主要终点
Sex risk

研究概览

简要总结

This study will draw from proven interventions to refine and pilot test a cue card driven computer-assisted intervention, along with HIV/STI testing, that will be tailored to each participant's demographic characteristics, risk behaviors, and biological test results. The specific aims of the proposed study are:

  1. To refine a cue card driven computer-assisted risk reduction intervention that will be tailored to each participant's demographic characteristics (e.g., gender, ethnicity), risk behaviors, and biological test results (HIV, hepatitis B and C, syphilis and herpes).
  2. To pilot test the tailored intervention's effects on sexual risk behaviors (e.g., frequency of unprotected sex, condom use), drug use during sex and injection risk behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group randomized design that compares the tailored intervention with a delayed treatment control condition.
  3. To assess the feasibility and acceptability of the tailored intervention in a rural setting.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The sample of 120 will be drawn from the Raleigh-Durham, NC metro area with the following targets:
  • 40 MSM (at least 12 African American, 12 non-Hispanic white and 12 Hispanic) - eligibility includes unprotected sex with another male in the past 30 days
  • 40 sex workers (at least 6 male and 6 female of each race/ethnicity) - eligibility includes unprotected sex within the last 30 days and exchange of sex for money or drugs within the past 30 days
  • 40 drug users who are not sex workers or MSM (at least 2 males and 2 females of each race/ethnicity) - eligibility includes use of methamphetamine, crack or powder cocaine, or heroin in the past 30 days and unprotected intercourse and/or syringe sharing in the past 30 days.
  • Additional eligibility criteria include the following:
  • be 18 years of age or older
  • self-identify as male or female
  • self-identify as African American, non-Hispanic white or Hispanic
  • not currently be in or seeking substance use treatment
  • speak and understand written English proficiently
  • be a resident of Wake, Durham, Orange, Johnston or Chatham counties, with no plans to move in the next 3 months

排除标准

  • 未提供

结局指标

主要结局

Sex risk

时间窗: 3 months

Compared with participants assigned to the control condition, participants assigned to the tailored intervention will report lower rates of unprotected sex at 3-month follow-up.

次要结局

  • Injection risk(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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