跳至主要内容
临床试验/NCT03935945
NCT03935945Unknown不适用

Personalized Feedback to Reduce HIV+ Hazardous Drinking in Primary Care

University of Houston2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Problematic Drinking

研究概览

简要总结

The objective of the proposed research is test the feasibility of a brief computer-based personalized feedback intervention to reduce heavy alcohol use among HIV+ individuals. There is a critical need to develop accessible, empirically-supported, low-threshold interventions for HIV+ hazardous alcohol users. The proposed research will develop and evaluate the feasibility, acceptability, and potential efficacy of a novel evidence- and computer-based Personalized Feedback Intervention (PFI) among HIV+ hazardous alcohol users in a high volume Houston HIV clinic.

H1: The PFI group will show increases in self-efficacy, intention to reduce or quit drinking, and decreases in actual drinking, relative to the control group.

H2: Reduced drinking will be associated with less risky sexual behavior, better antiretroviral therapy (ART) medication adherence, and improved HIV quality of life.

H3: Changes in normative perceptions, alcohol use attitudes, self-efficacy for alcohol abstinence, intentions to use, alcohol outcome expectancies, and protective behavioral strategies will mediate intervention effects on drinking behavior. Even if the investigators do not find significant effects on our main outcomes, these will also serve as useful proximal dependent variables that will provide important information regarding the feasibility of this intervention approach in this population.

H4: Intervention effects on drinking outcomes will be stronger for those who report drinking more for social and/or coping reasons.

详细描述

The objective of the proposed research is test the feasibility of a brief computer-based personalized feedback intervention to reduce heavy alcohol use among HIV+ individuals. Rates of hazardous alcohol use among HIV+ individuals are approximately two times that found in the general population. Hazardous alcohol use contributes to problems with HIV medication adherence, risky sexual behavior, and psychological problems, as well as physical complications (rapid disease progression, medication toxicities, organ failure, and poor viremic control), which may lead to increased risk of transmission and premature death. Yet, HIV+ hazardous alcohol users remain a hard-to-reach and underserved group. There is therefore a critical need to test alternative approaches to the implementation of effective interventions to reduce HIV disease transmission and progression in HIV+ hazardous alcohol users. One novel and promising intervention approach is the use of personalized feedback, which has consistently been found to be efficacious for reducing hazardous alcohol use across a number of populations. Personalized feedback highlights discrepancies between one's own drinking and typical drinking; reframes use in terms of personal, social, financial, health, and other consequences; and offers strategies for reducing use and alcohol-related negative consequences. The proposed research will develop and evaluate the feasibility, acceptability, and potential efficacy of a novel evidence- and computer-based Personalized Feedback Intervention (PFI) among HIV+ hazardous alcohol users in a high volume Houston HIV clinic. The investigators will recruit 150 HIV+ hazardous alcohol users randomly assigned to receive either PFI or attention-control feedback (e.g., diet, exercise). The investigators expect to demonstrate feasibility and acceptability of the PFI. Outcomes include drinking change processes and behavior, alcohol-related risky sexual behavior, and HIV-related outcomes. An underlying premise, which will be evaluated through the aims, is that the difficulty in reaching hazardous alcohol users who are HIV+ can be addressed with an approach that will not be burdensome to the individuals or to clinic staff. All assessments and procedures will take place in the clinic on tablets or laptop computers. Follow-up assessments will occur at 3 months post-baseline. This research builds on the collaborative work of an experienced team of investigators with complementary expertise supporting all aspects of the proposed research.

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
Single (Participant)

入排标准

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

入选标准

  • HIV+ as confirmed by medical records
  • AUDIT scores for the last 30 days to be ≤7 for women and ≤8 for men
  • Between the ages of 18 and 50
  • Not currently pregnant
  • Reading level on Word Reading component of Wide Range Achievement Test (WRAT-4) at or above a 5th grade level and proficient in English (although English does not have to be the first language, they must be fluent enough to understand study materials and measures)
  • Not currently in alcohol treatment
  • Do not have a current psychiatric diagnosis that would preclude them from being in our study as determined by the MINI (MINI INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW) neuropsychiatric interview

排除标准

  • Not meeting inclusion criteria
  • Unwillingness to participate
  • Failure to provide consent

研究组 & 干预措施

Personalized Feedback Intervention (PFI)

Experimental

Participants in the intervention group will receive a computerized personalized feedback intervention (PFI) lasting approximately 20-30 minutes.

干预措施: Personalized Feedback Intervention (Behavioral)

Attention-Control

No Intervention

Attention control information will be comparable in focus on health-related behaviors (e.g., nutrition, exercise). We will use behaviors in the attention control feedback that are not associated with study outcomes. Attention control feedback will have text and graphs that are similar in appearance and length (i.e., 20-30 minutes) to intervention feedback.

结局指标

主要结局

Problematic Drinking

时间窗: Change from baseline to 3-month follow-up

This outcome looks at the amount of alcohol consumed and any alcohol-related consequences as a result of participant drinking. This outcome will be measured by the change in responses of the Alcohol Use Disorders Identification Test (AUDIT) between baseline and 3-month follow-up.

Consequences

时间窗: Change from baseline to 3-month follow-up

This outcome looks at any consequences related to drinking. This outcome will be measured by the change in responses of the Drinker Inventory of Consequences (DRINC) between baseline and 3-month follow-up.

Quantity of Alcohol Consumed in Single Occasion

时间窗: Change from baseline to 3-month follow-up

This involves the number of drinks consumed in a single occasion in the past month. This outcome will be measured by the change in responses of Quantity-Frequency-Peak Alcohol Use Index (QF) between baseline and 3-month follow-up.

Typical weekly drinking

时间窗: Change from baseline to 3-month follow-up

Typical weekly drinking will be measured with the Daily Drinking Questionnaire (DDQ), which asks how much a person drinks on a typical day of each week, for the past 3 months. Drinks will be measured by standard drinks. The scale ranges from 0 drinks to 25 drinks per day (leading to a maximum for 175 weekly drinks).

次要结局

  • Alcohol-related sexual behavior(Change from baseline to 3-month follow-up)
  • Quality of Life(Change from baseline to 3-month follow-up)
  • Sexual behavior(Change from baseline to 3-month follow-up)
  • Viral load measures(Change from baseline to 3-month follow-up)
  • Unannounced pill counts(Change from baseline to 3-month follow-up)
  • Medication Adherence(Change from baseline to 3-month follow-up)

研究者

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

Clayton Neighbors

Moores Professor and Director of Social Psychology Program

University of Houston

研究点 (2)

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