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临床试验/NCT02391233
NCT02391233已完成不适用

Multimedia HIV/STI Prevention for Black Drug-Involved Women on Probation

Columbia University2 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2015年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
354
试验地点
2
主要终点
Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.

研究概览

简要总结

The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as Black) women drug users in probation sites in New York City (NYC), compared to streamlined HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post intervention. The primary outcomes will be to reduce cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex acts.

详细描述

This randomized controlled trial will be conducted with 420 drug-involved Black women at 5 probation sites located in communities in NYC heavily affected by HIV and STIs. Eligible women will be randomly assigned to: (1) WORTH consisting of an individual evidence-based Streamlined HIV Testing session followed by a 4-session group-based multimedia HIV intervention (WORTH) or (2) an individual Streamlined HIV Testing session alone (Streamlined HIV Testing), which will serve as the comparison condition. Both conditions will be delivered by Fortune providers at the 5 sites. Self-reported data on behavioral outcomes will be collected from participants via audio computer-assisted self-interview (ACASI). Primary STI outcomes will be measured via biological assay for infection by Neisseria gonorrhea, trichomonas, and Chlamydia trachomatis, the most common STIs found among women in NYC. Women who meet eligibility criteria will undergo a pre-intervention assessment. This assessment will last approximately 60 minutes, consisting of demographic information, history of criminal justice involvement, drug and alcohol use and dependence, sexual and drug-related HIV behaviors, HIV treatment and care, intimate partner violence, depression and posttraumatic Stress Disorder (PTSD) , service utilization, and social support. Research assistants (RAs) will schedule repeated assessments with participants that will take place at baseline and at 3, 6, and 12 months post-intervention. Each participant will be asked to obtain one vaginal specimen for STI testing by inserting a sterile Dacron-tipped swab about 2.5 inches or as far as comfortable into the vagina, rotating it for 15 to 30 seconds, and removing it. The vaginal swabs are placed into separate specimen transport packaging.

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 (Investigator)

入排标准

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

入选标准

  • She is 18 or older.
  • She is currently supervised by a criminal justice entity, such as a community court or probation.
  • She reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days
  • She reports any illicit drug use or binge drinking in the past 6 months

排除标准

  • Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
  • The woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional HIV risk behaviors in the past 90 days:
  • Having sex with more than one partner
  • Having sex with a partner known or suspected to be HIV positive or an injection drug user (IDU)
  • Sharing injection drug use needles or equipment
  • The woman is actively trying to get pregnant/have a baby.
  • Inability to complete informed consent process due to a psychiatric or cognitive impairment.
  • The participant was born male.

结局指标

主要结局

Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.

时间窗: Baseline and 12 months post-intervention

Change in the number of unprotected sex acts

时间窗: Baseline and 12 months post-intervention

次要结局

  • Comparative change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.(12-month)
  • Change in the number of unprotected sex acts as moderated by sociodemographics and professional training, attitudes, and self-efficacy of probation officers, administrators, and probation providers from Fortune Society(6-month)
  • Change in the number of unprotected sex acts as moderated by participant race, age and other socio-demographics and psychosocial client characteristics infection rates, drug use and projected number of HIV cases averted at the 12-month follow-up.(12-month)
  • Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas as moderated by participant race, age and other socio-demographics and psychosocial client characteristics(12-months)
  • Change in cumulative incidence of biologically confirmed STIs as moderated by sociodemographics and professional training, attitudes, and self-efficacy of probation officers, administrators, and probation providers from Fortune Society(6-month)
  • Comparative change in the number of unprotected sex acts(12-month)

研究者

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

Louisa Gilbert

Co-Director, Social Intervention Group, Columbia University School of Social Work, New York / Associate Professor, Columbia University School of Social Work, New York

Columbia University

研究点 (2)

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