跳至主要内容
临床试验/NCT01379599
NCT01379599已完成3 期

Brief Intervention to Reduce STDs in ER Drug Users

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 1,030 人开始时间: 2004年11月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,030
试验地点
2
主要终点
unprotected sexual acts

研究概览

简要总结

The goal of the proposed project is to determine the effectiveness of a brief motivational intervention among Emergency Department (ED) patients who use cocaine and/or heroin to prevent Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV) by comparing cumulative incidence and frequency of safe sex behavior between intervention and standard voluntary counseling, testing and referral to substance abuse treatment (control) groups over a one year follow-up period.

详细描述

Barriers to health care utilization limit drug users' interaction with the primary health care system, resulting in episodic health care received through Emergency Departments (ED) and Urgent Care Centers (UCC). Since 1994, the Boston Medical Center ED and UCC have provided substance abuse screening as standard of care. This program employs the Brief Negotiated Interview (BNI) to assess patient's reasons for drug use, readiness to change and offer intervention alternatives and referrals to substance treatment and other resources. Drug users' high rates of STIs, HIV, and Hepatitis C (HCV) and utilization of EDs and UCCs as usual sources of health care support the introduction of sexual behavior intervention in the ED and UCC setting. The proposed study will apply existing Brief Negotiation Interview (BNI) theory and research to a new behavioral context. The proposed project is a collaborative effort to adapt the BNI to encourage safe sex behaviors to prevent gonorrhea, chlamydia, and HIV among male and female ED and UCC patients age 18-54 years who use heroin and/or crack/cocaine and are not in treatment. We will enroll and 1:1 randomize 1,030 patients to intervention (safe sex BNI) or control (voluntary counseling and testing and referral to substance abuse treatment) over a 2.5-year period, with 6-month and 12-month follow-up. STIs and HIV will be diagnosed by specific laboratory assay at baseline, 6-month, and 12-month follow-up. Sexual and drug using behavior will be determined by participant self-report at baseline, 6-month, and 12-month follow-up on a 30 day time-line follow-up calender, with biochemical testing of hair samples for opiates and cocaine at enrollment and 12-month follow-up. Sexual behavior risk will be measured in terms of proportion of vaginal and anal sex acts protected by condom use and condom use at last sexual act, by sexual partner type. Differences in safe sex behavior between intervention and control groups will be evaluated using General Estimating Equation (GEE) modeling. After assessing intervention effect in the base model, we will assess intervention effect controlling for age, gender, race, injection use, HIV status and sexual and drug using behavior. An effective, brief intervention for safe sex behaviors to reduce STDs and HIV among drug users in ED and UCC settings may provide a sustainable intervention opportunity for drug users who are otherwise difficult to access.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 54 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • registered ER patient
  • English and Spanish speakers
  • 30 day use of heroin and or cocaine
  • DAST score=>3

排除标准

  • severity of medical illness
  • suicidality
  • police custody
  • residential substance abuse treatment
  • ability to provide contact information

结局指标

主要结局

unprotected sexual acts

时间窗: 1 year

次要结局

  • sex acts while high on drugs(1 year)

研究者

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

Edward Bernstein

Professor of Emergency Medicine BU SOM; Professor of Community Health Sciences BUSPH

Boston Medical Center

研究点 (2)

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