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出境医 / 临床实验 / Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic

Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Alcohol Consumption Behavioral: Personalized Feedback Intervention Not Applicable

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Personalized Feedback to Reduce HIV+ Hazardous Drinking in Primary Care
Actual Study Start Date : January 20, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : January 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Personalized Feedback Intervention (PFI)
Participants in the intervention group will receive a computerized personalized feedback intervention (PFI) lasting approximately 20-30 minutes.
 Behavioral: Personalized Feedback Intervention
Participants in the intervention group will receive a computerized personalized feedback intervention (PFI) lasting approximately 20-30 minutes. PFI highlights discrepancies between one's own drinking and typical drinking; reframes use in terms of personal, social, financial, and health consequences; and, offers strategies for reducing alcohol use. The feedback is non-confrontational in tone, seeks to increase motivation to reduce drinking and is based on the information provided during the baseline assessment
No Intervention: Attention-Control
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.
Outcome Measures
Primary Outcome Measures :
  1. Typical weekly drinking [ Time Frame: 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).

  2. Quantity of Alcohol Consumed in Single Occasion [ Time Frame: 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.

  3. Problematic Drinking [ Time Frame: 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.

  4. Consequences [ Time Frame: 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.


Secondary Outcome Measures :
  1. Sexual behavior [ Time Frame: Change from baseline to 3-month follow-up ]
    Sexual behavior will be assessed with questions about sex partners, unprotected sex, vaginal/anal sex, sex with alcohol will be assessed via the Sexual Behavior and Alcohol-Related Sexual Behavior questionnaire, a questionnaire previously used by Dr. Lewis that is well-validated and has been used in her prior NIH funded work. The Alcohol-Related Sexual Behavior questionnaire ranges from none to 25+ times for the amount of time that participants engaged in sex in the past 3 months.

  2. Alcohol-related sexual behavior [ Time Frame: Change from baseline to 3-month follow-up ]
    Sex with alcohol will be assessed via the Sexual Behavior and Alcohol-Related Sexual Behavior questionnaire, a questionnaire previously used by Dr. Lewis that is well-validated and has been used in her prior NIH funded work. The Alcohol-Related Sexual Behavior questionnaire ranges from none to 25+ times for alcohol use in conjunction with oral, vaginal, or anal sex.

  3. Medication Adherence [ Time Frame: Change from baseline to 3-month follow-up ]
    Medication adherence will be measured using self-report (ACTG questionnaire), which asks questions as to a patient's medication adherence from a scale of 0 (not at all) to 3 (extremely sure).

  4. Viral load measures [ Time Frame: Change from baseline to 3-month follow-up ]
    Viral load measures will be determined through chart review with permission from the research participant.

  5. Unannounced pill counts [ Time Frame: Change from baseline to 3-month follow-up ]
    Unannounced pill counts will provide an objective measure of adherence that is significantly associated with other measures of adherence including electronic monitors.

  6. Quality of Life [ Time Frame: Change from baseline to 3-month follow-up ]
    We will also assess HIV-related quality of life with the validated World Health Organization (WHO) HIV Quality of Life measure.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not meeting inclusion criteria
  • Unwillingness to participate
  • Failure to provide consent
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Clayton Neighbors, PhD 713-743-2616 cneighbors@uh.edu
Contact: Joanne Angosta, BA jangosta@central.uh.edu

Locations
Layout table for location information
United States, Texas
Thomas Street Health Center Recruiting
Houston, Texas, United States, 77009
Contact: Thomas P Giordano, MD    713-798-8918    tpg@bcm.edu   
Contact: Tanisha T Bell, MPH    (713) 873-4526    darko@bcm.edu   
Sponsors and Collaborators
University of Houston
Baylor College of Medicine
Tracking Information
First Submitted Date  ICMJE January 10, 2018
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE January 20, 2018
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Typical weekly drinking [ Time Frame: 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).
  • Quantity of Alcohol Consumed in Single Occasion [ Time Frame: 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.
  • Problematic Drinking [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Sexual behavior [ Time Frame: Change from baseline to 3-month follow-up ]
    Sexual behavior will be assessed with questions about sex partners, unprotected sex, vaginal/anal sex, sex with alcohol will be assessed via the Sexual Behavior and Alcohol-Related Sexual Behavior questionnaire, a questionnaire previously used by Dr. Lewis that is well-validated and has been used in her prior NIH funded work. The Alcohol-Related Sexual Behavior questionnaire ranges from none to 25+ times for the amount of time that participants engaged in sex in the past 3 months.
  • Alcohol-related sexual behavior [ Time Frame: Change from baseline to 3-month follow-up ]
    Sex with alcohol will be assessed via the Sexual Behavior and Alcohol-Related Sexual Behavior questionnaire, a questionnaire previously used by Dr. Lewis that is well-validated and has been used in her prior NIH funded work. The Alcohol-Related Sexual Behavior questionnaire ranges from none to 25+ times for alcohol use in conjunction with oral, vaginal, or anal sex.
  • Medication Adherence [ Time Frame: Change from baseline to 3-month follow-up ]
    Medication adherence will be measured using self-report (ACTG questionnaire), which asks questions as to a patient's medication adherence from a scale of 0 (not at all) to 3 (extremely sure).
  • Viral load measures [ Time Frame: Change from baseline to 3-month follow-up ]
    Viral load measures will be determined through chart review with permission from the research participant.
  • Unannounced pill counts [ Time Frame: Change from baseline to 3-month follow-up ]
    Unannounced pill counts will provide an objective measure of adherence that is significantly associated with other measures of adherence including electronic monitors.
  • Quality of Life [ Time Frame: Change from baseline to 3-month follow-up ]
    We will also assess HIV-related quality of life with the validated World Health Organization (WHO) HIV Quality of Life measure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic
Official Title  ICMJE Personalized Feedback to Reduce HIV+ Hazardous Drinking in Primary Care
Brief Summary

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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Alcohol Consumption
Intervention  ICMJE Behavioral: Personalized Feedback Intervention
Participants in the intervention group will receive a computerized personalized feedback intervention (PFI) lasting approximately 20-30 minutes. PFI highlights discrepancies between one's own drinking and typical drinking; reframes use in terms of personal, social, financial, and health consequences; and, offers strategies for reducing alcohol use. The feedback is non-confrontational in tone, seeks to increase motivation to reduce drinking and is based on the information provided during the baseline assessment
Study Arms  ICMJE
  • Experimental: Personalized Feedback Intervention (PFI)
    Participants in the intervention group will receive a computerized personalized feedback intervention (PFI) lasting approximately 20-30 minutes.
    Intervention: Behavioral: Personalized Feedback Intervention
  • No Intervention: Attention-Control
    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.
Publications *
  • Wong CCY, Paulus DJ, Lemaire C, Leonard A, Sharp C, Neighbors C, Brandt CP, Lu Q, Zvolensky MJ. Examining HIV-Related stigma in relation to pain interference and psychological inflexibility among persons living with HIV/AIDS: The role of anxiety sensitivity. J HIV AIDS Soc Serv. 2018;17(1):1-15. doi: 10.1080/15381501.2017.1370680. Epub 2017 Nov 30.
  • Paulus DJ, Jardin C, Bakhshaie J, Sharp C, Woods SP, Lemaire C, Leonard A, Neighbors C, Brandt CP, Zvolensky MJ. Anxiety sensitivity and hazardous drinking among persons living with HIV/AIDS: An examination of the role of emotion dysregulation. Addict Behav. 2016 Dec;63:141-8. doi: 10.1016/j.addbeh.2016.07.013. Epub 2016 Jul 21.
  • Wong CCY, Paulus DJ, Lemaire C, Leonard A, Sharp C, Neighbors C, Brandt CP, Zvolensky MJ. Emotion Dysregulation: An Explanatory Construct in the Relation Between HIV-Related Stigma and Hazardous Drinking among Persons Living with HIV/AIDS. Stigma Health. 2019 Aug;4(3):293-299. doi: 10.1037/sah0000113. Epub 2018 Jun 7.
  • Brandt CP, Jardin C, Sharp C, Lemaire C, Zvolensky MJ. Main and interactive effects of emotion dysregulation and HIV symptom severity on quality of life among persons living with HIV/AIDS. AIDS Care. 2017 Apr;29(4):498-506. doi: 10.1080/09540121.2016.1220484. Epub 2016 Aug 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not meeting inclusion criteria
  • Unwillingness to participate
  • Failure to provide consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935945
Other Study ID Numbers  ICMJE uhouston
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clayton Neighbors, University of Houston
Study Sponsor  ICMJE University of Houston
Collaborators  ICMJE Baylor College of Medicine
Investigators  ICMJE Not Provided
PRS Account University of Houston
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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