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临床试验/NCT03323086
NCT03323086已完成不适用

Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年10月18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
50
试验地点
2
主要终点
Feasibility of Providing Intervention

研究概览

简要总结

This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).

详细描述

This study will assess the feasibility and acceptability, and obtain initial evidence of the efficacy, of the BI and technology extenders. At-risk women drinkers (N = 50) recruited from a reproductive health care clinic will be assessed, randomly assigned to the integrated BI or control (a Centers for Disease Control and Prevention-produced brochure with information about alcohol and women's health), and reassessed at 3 months to determine impact on alcohol use, condom use, and number of partners as well as hypothesized mediators.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 18-29 years
  • Meeting NIAAA definition of "at-risk" drinking (>3 drinks on any day in the last 3 months18 and/or >7 drinks per week)
  • Sexual risk behavior (i.e., last 3 months: vaginal/anal intercourse with >1 partner; vaginal/anal intercourse with a partner who has other partners; inconsistent condom use; new relationship (under 3 months))
  • English speaking
  • Absence of acute intoxication, depression, or suicidal ideation
  • No plans for relocation

排除标准

  • Under 18 years old or older than 29 years old
  • Non-English speaking
  • Suicidal Ideation
  • Relocating
  • Clinic provider advising against recruitment in the study
  • Unwilling or unable to provide consent

结局指标

主要结局

Feasibility of Providing Intervention

时间窗: Immediately following intervention session (post-intervention), up to 30 minutes

percentage of individuals who attended their intervention

次要结局

  • Alcohol Use Quantity(3-month Follow-up)
  • Alcohol Use Binge Frequency(3-month Follow-up)
  • Session Evaluation Questionnaire(Immediately following intervention session (post-intervention), up to 30 minutes)
  • Number of Sexual Partners(3-month Follow-up)
  • Condomless Sex(3-month Follow-up)

研究者

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

Michael P. Carey

Professor and Director, Centers for Behavioral and Preventive Medicine, The Miriam Hospital

The Miriam Hospital

研究点 (2)

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