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临床试验/NCT04821427
NCT04821427已完成不适用

Feasibility of an mHealth + Brief Intervention for Heavy Drinking African American and Latino MSM: A Pilot Study

Boston University Charles River Campus1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Modified Daily Drinking Questionnaire - Heavy Drinking Episodes

研究概览

简要总结

Randomized controlled pilot trial to test the feasibility and efficacy of a brief intervention with app-based messaging to reduce sexual risk behavior and heavy drinking among Black/African American and Hispanic/Latino MSM.

详细描述

This study seeks to develop and provide an initial test of a brief intervention to reduce alcohol use and sex risk behavior among Black and Latino men who have sex with men [BLMSM]. The study seeks to recruit BLMSM who are non-monogamous, not currently on pre-exposure prophylaxis [PrEP], have engaged in condomless anal intercourse over the past 6 months, who have engaged in heavy drinking defined as >14 drinks per week or at least 1 heavy drinking episode (5+ drinks on a single occasion) in the past month. All participants will complete baseline measures about past month behavior and if eligible will be assigned to the intervention condition or an assessment only condition. The intervention consists of a single brief video-conferencing intervention coupled with 4 weeks of mobile-messaging related to individualized goals about alcohol use and sexual behavior. Follow-up assessments are scheduled for 4 weeks after baseline (upon completion of the mobile-messaging component of the intervention) and 2 months after baseline. Primary outcomes are feasibility and acceptability of the intervention and mobile-messaging components. Secondary outcomes are changes in frequency of condomless anal intercourse and heavy drinking episodes.

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
None

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Black/African American or Latino/Hispanic
  • At least one heavy drinking episode in past month
  • At least one episode of condomless anal intercourse with another man in the past 6 months
  • Own a smartphone
  • English speaking

排除标准

  • Currently on PrEP
  • Monogamous/exclusive relationship
  • Past or current treatment for alcohol (past 3 years)
  • Current or past psychiatric treatment (past 3 months)
  • Diagnosis of Bipolar Disorder or Schizophrenia
  • Brief Michigan Alcoholism Screening Test score >5
  • Lifetime diagnosis of substance use disorder
  • ASSIST score of >/=27 for any individual substance

研究组 & 干预措施

Assessment Only

No Intervention

This is an assessment only condition. No intervention following completion of baseline surveys will be administered.

Brief mHealth Intervention + mobile messaging

Experimental

The intervention is a brief, motivational video-conferencing intervention followed by four weeks of app-based, interactive mobile messages

干预措施: Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking (Behavioral)

结局指标

主要结局

Modified Daily Drinking Questionnaire - Heavy Drinking Episodes

时间窗: Past 30 days

Number of heavy drinking episodes NIAAA criteria (5+ drinks)

Sexual Behavior - Extended Survey - Condomless Anal Intercourse

时间窗: Past 30 days

Frequency of condomless anal intercourse. This is an open ended question where the Participant reports the frequency of condomless anal intercourse over the past 30 days.

次要结局

  • Goal Systems Assessment Battery - Alcohol(Past 30 days)
  • Goal Systems Assessment Battery - Condom Use(Past 30 days)
  • Intervention Acceptability Ratings(2 months post-baseline)
  • Client Satisfaction Questionnaire(2 months post-baseline)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Sponsor
主要研究者

Kathryn Chavez

Clinical Psychology Doctoral Candidate, Department of Psychological and Brain Sciences

Boston University Charles River Campus

研究点 (1)

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