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临床试验/NCT01381653
NCT01381653已完成不适用

An Innovative HIV Prevention Intervention Using Social Networking Technology

Hunter College of City University of New York2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
feasibility and acceptability of intervention delivery

研究概览

简要总结

An existing face-to-face HIV prevention intervention (The Young Men's Health Project, YMHP; R01DA20366) will be iteratively adapted and pilot-tested to target difficult to engage high-risk young men who have sex with men (YMSM) via online social networking and aims to reduce both high-risk sexual behavior and drug use.

详细描述

This pilot study entails a two-phase process. During Phase I, 15 former YMHP participants (intervention decliners and those who only completed one session) will participate in focus groups to advise us on the feasibility and pragmatic specifications of an HIV prevention intervention received via the IM (instant messaging) function of Facebook. Focus group transcripts will be examined to isolate key recommendations for modifying the intervention's structure and procedures. Focus groups will be reconvened for additional feedback on the modified intervention, followed by further adjustment. During Phase II, 40 high-risk YMSM (ages 18-29 and Facebook users) will be enrolled in a pilot of the modified intervention. The intervention will span 4 weeks and contain 8 bi-weekly 30 minute Motivational Interviewing (MI) chat-window sessions consisting of a sequential progression of intervention approaches tailored to each participant's readiness to change their drug use and high risk sexual behavior. Data from Phase II will include pre-post intervention behavioral risk assessments, as well as individual interviews with all 40 intervention participants for a qualitative evaluation regarding the feasibility and acceptability of the intervention's structure, and process. Findings from these interviews (and counselor focus group) will inform the fine-tuning of the intervention in preparation for a subsequent randomized control trial (RCT).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • For the focus group portion of the study (N=20), we will invite former YMHP participants who declined the intervention or only completed one session, agreed to be contacted for future studies, indicated using Facebook, are still between the ages of 18-29 and live in NYC.
  • To qualify for the intervention portion of the study, participants must report
  • at least 5 days of drug use (of 1 or more of the following drugs: cocaine, methamphetamine (MA), or ecstasy (MDMA) in the prior three months;
  • high-risk sexual behavior (1 or more acts of unprotected insertive or receptive anal sex with a male partner of unknown or HIV+ serostatus), in the prior three months;
  • biologically male;
  • age 18 to 29;
  • reliable Internet access;
  • Facebook use at least four times per week;
  • able to write in English given that intervention participation involves writing;
  • NYC residency.

排除标准

  • Participants will be excluded for any of the following reasons:
  • Unstable, serious psychiatric symptoms;
  • Currently suicidal/homicidal;
  • Evidence of gross cognitive impairment;
  • Self-reported current enrollment in a drug or HIV-related intervention or research study.
  • We exclude those with serious cognitive or psychiatric impairments because this would compromise ability to participate, regardless of whether these impairments are attributed to drug use. Such impairments would make completion of assessments difficult.
  • Excluded participants will be referred to local community health and social services resources, for which we have established linkages to facilitate access to care regardless of ability to pay.

结局指标

主要结局

feasibility and acceptability of intervention delivery

时间窗: 1 month

Participants (N=40) who received eight 30-minute sessions of Motivational Interviewing (to reduce substance use and sexual risk) over instant messaging on Facebook will be interviewed to evaluate the intervention delivery and structure, including their perceived connection with the counselor and concerns with receiving an intervention online.

次要结局

未报告次要终点

研究者

发起方
Hunter College of City University of New York
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey T. Parsons

Professor

Hunter College of City University of New York

研究点 (2)

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