Multi-Level HIV Prevention for Pregnant Drug Abusers

National Institute on Drug Abuse (NIDA)0 个研究点目标入组 250 人开始时间: 2006年10月最近更新: 2017年1月11日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: National Institute on Drug Abuse (NIDA)
入组人数: 250
主要终点: Sexual risk behavior

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen relationship-based social competency skills of the original BST that were crucial in sustaining adherence to protective behavior.

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: Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

•18 years of age or older
•a recent history (within the past year) of using illicit substances
•12-32 weeks pregnant and not planning to terminate the pregnancy
•able to read English Informed Consent form; understand and provided written informed consent
•have competency in conversational English which is required to complete assessments and to participate in the intervention groups
•have a stable living arrangement and provide contact information
•currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention
•currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality
•report at least one episode of unprotected vaginal/anal sex since becoming pregnant
•answer "Yes" to this question: "Do you plan to be in the area for the next 12 months?"
•agree to a urine test at the time of each interview to detect the presence of drugs

排除标准

•under age 18 years

结局指标

主要结局

Sexual risk behavior

时间窗: 6 months post intervention

Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers

次要结局

Drug use risk behavior(6 months post intervention)

研究者

发起方

National Institute on Drug Abuse (NIDA)

申办方类型

Nih

责任方

Sponsor

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