Brief Intervention to Reduce STDs in ER Drug Users

减少急诊吸毒者性传播疾病的简短干预措施

• 批准号: 7032332
• 负责人: Edward Bernstein Bernstein
• 金额: $ 48.36万
• 依托单位: BOSTON MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7032332
• 关键词: AIDS education /prevention; HIV infections; behavioral /social science research tag; chlamydial disease; clinical research; cocaine; communicable disease control; communicable disease diagnosis; counseling; drug abuse; drug detection; emergency care; gonorrhea; heroin; high risk behavior /lifestyle; hospitals; human subject; human therapy evaluation; interview; longitudinal human study; medically underserved population; motivation; opiate alkaloid; patient oriented research; safe sex /sex abstinence; sex behavior; sexually transmitted diseases; substance abuse related behavior

DESCRIPTION (provided by applicant): 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 BMC ED and UCC have provided substance abuse screening as standard of care. This program employs the Brief Negotiated Interview (BNI) to assess readiness to change and offer intervention alternatives and referrals to substance abusing patients. Drug users' high rates of STDs, 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 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 18-44 years who use heroin and/or crack/cocaine and are not in treatment. We will enroll and 1:1 randomize 3,340 patients to intervention (safe sex BNI) or control (standard counseling) over a 2.5-year period, with 6- month and 12-month follow-up. Enrollment will begin Month 9 of Year 1 and Follow-Up will be completed Month 3 of Year 5. The goal of the proposed project is to determine the effectiveness of safe sex BNI counseling to prevent STDs and HIV by comparing cumulative STD incidence and frequency of safe sex behavior between intervention and standard counseling (control) groups over a one year follow-up period. STD 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 by participant self-report at baseline, 6-month, and 12-month follow-up, 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. Stage of change will be assessed by the Readiness Ruler. Differences in cumulative incidence between intervention and control groups will be evaluated using Poisson regression with random effects modeling if needed. Differences in safe sex behavior between intervention and control groups will be evaluated using logistic regression. After assessing intervention effect in the base model, we will assess intervention effect controlling for age, gender, race, and baseline readiness to change and sexual and drug using behavior. We will conduct exploratory analyses for the potential interaction and mediating effects between intervention status and abstinence from drug use on incidence of STDs and self-reported behaviors. 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.

描述（由申请人提供）：医疗保健利用的障碍限制了吸毒者与初级卫生保健系统的互动，导致他们只能通过急诊科 (ED) 和紧急护理中心 (UCC) 获得间歇性的医疗保健。自 1994 年以来，BMC ED 和 UCC 提供药物滥用筛查作为护理标准。该计划采用简短协商访谈 (BNI) 来评估改变的准备情况，并为药物滥用患者提供干预替代方案和转介。吸毒者性传播疾病、艾滋病毒和丙型肝炎 (HCV) 的高发病率以及将急诊室和 UCC 作为通常的医疗保健来源的利用支持在 ED 和 UCC 环境中引入性行为干预。拟议的研究将现有的 BNI 理论和研究应用于新的行为背景。拟议的项目是一项合作努力，旨在调整 BNI，鼓励安全性行为，以预防年龄 18-44 岁的男性和女性 ED 和 UCC 患者中的淋病、衣原体和艾滋病毒，这些患者使用海洛因和/或快克/可卡因且不患有艾滋病。治疗。我们将在 2.5 年的时间内招募 3,340 名患者，并按 1:1 随机分配进行干预（安全性行为 BNI）或对照（标准咨询），并进行 6 个月和 12 个月的随访。登记将于第 1 年第 9 个月开始，随访将于第 5 年第 3 个月完成。拟议项目的目标是通过比较累计 STD 发病率和频率，确定安全性行为 BNI 咨询对于预防 STD 和 HIV 的有效性。干预组和标准咨询（对照组）组在一年的随访期内的安全性行为。 STD 和 HIV 将在基线、6 个月和 12 个月随访时通过特定实验室检测进行诊断。性行为和吸毒行为将由参与者在基线、6 个月和 12 个月随访时自我报告，并在入组和 12 个月随访时对头发样本进行阿片类和可卡因生化检测。性行为风险将根据使用安全套保护的阴道性交和肛交行为的比例以及最后一次性行为中使用安全套的比例（按性伴侣类型）来衡量。变更阶段将由准备标尺进行评估。如果需要，将使用带有随机效应模型的泊松回归来评估干预组和对照组之间累积发生率的差异。将使用逻辑回归评估干预组和对照组之间安全性行为的差异。在评估基本模型中的干预效果后，我们将评估控制年龄、性别、种族、改变基线准备度以及性行为和吸毒行为的干预效果。我们将对干预状态和戒毒之间对 STD 发生率和自我报告行为的潜在相互作用和中介效应进行探索性分析。对安全性行为进行有效、简短的干预，以减少 ED 和 UCC 环境中吸毒者的 STD 和 HIV，可能为难以接触的吸毒者提供可持续的干预机会。