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Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic

Primary Purpose

Alcohol Consumption

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Feedback Intervention
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Consumption focused on measuring Drinking, Alcohol, HIV+

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Street Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Personalized Feedback Intervention (PFI)

Attention-Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Typical weekly drinking
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
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
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
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

Sexual behavior
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
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
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
Viral load measures will be determined through chart review with permission from the research participant.
Unannounced pill counts
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
We will also assess HIV-related quality of life with the validated World Health Organization (WHO) HIV Quality of Life measure.

Full Information

First Posted
January 10, 2018
Last Updated
May 1, 2019
Sponsor
University of Houston
Collaborators
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03935945
Brief Title
Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic
Official Title
Personalized Feedback to Reduce HIV+ Hazardous Drinking in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
Drinking, Alcohol, HIV+

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Feedback Intervention (PFI)
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive a computerized personalized feedback intervention (PFI) lasting approximately 20-30 minutes.
Arm Title
Attention-Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Feedback Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Typical weekly drinking
Description
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).
Time Frame
Change from baseline to 3-month follow-up
Title
Quantity of Alcohol Consumed in Single Occasion
Description
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.
Time Frame
Change from baseline to 3-month follow-up
Title
Problematic Drinking
Description
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.
Time Frame
Change from baseline to 3-month follow-up
Title
Consequences
Description
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.
Time Frame
Change from baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
Sexual behavior
Description
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.
Time Frame
Change from baseline to 3-month follow-up
Title
Alcohol-related sexual behavior
Description
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.
Time Frame
Change from baseline to 3-month follow-up
Title
Medication Adherence
Description
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).
Time Frame
Change from baseline to 3-month follow-up
Title
Viral load measures
Description
Viral load measures will be determined through chart review with permission from the research participant.
Time Frame
Change from baseline to 3-month follow-up
Title
Unannounced pill counts
Description
Unannounced pill counts will provide an objective measure of adherence that is significantly associated with other measures of adherence including electronic monitors.
Time Frame
Change from baseline to 3-month follow-up
Title
Quality of Life
Description
We will also assess HIV-related quality of life with the validated World Health Organization (WHO) HIV Quality of Life measure.
Time Frame
Change from baseline to 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clayton Neighbors, PhD
Phone
713-743-2616
Email
cneighbors@uh.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne Angosta, BA
Email
jangosta@central.uh.edu
Facility Information:
Facility Name
Thomas Street Health Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas P Giordano, MD
Phone
713-798-8918
Email
tpg@bcm.edu
First Name & Middle Initial & Last Name & Degree
Tanisha T Bell, MPH
Phone
(713) 873-4526
Email
darko@bcm.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30034300
Citation
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.
Results Reference
background
PubMed Identifier
27497249
Citation
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.
Results Reference
background
PubMed Identifier
31777759
Citation
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.
Results Reference
background
PubMed Identifier
27546879
Citation
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.
Results Reference
background

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Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic

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