Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic

Alcohol Consumption Clinical Trial

Official title:

Personalized Feedback to Reduce HIV+ Hazardous Drinking in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03935945
• Other study ID #: uhouston
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2019
• Source: University of Houston
• Contact: Clayton Neighbors, PhD
• Phone: 713-743-2616
• Email: cneighbors[@]uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

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

Locations

Country	Name	City	State
United States	Thomas Street Health Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Wong, C. C. Y., Paulus, D. J., Lemaire, C., Leonard, A., Sharp, C., Neighbors, C., Brandt, C. P., & Zvolensky, M. J. (in press). Emotion dysregulation: An explanatory construct in the relation between HIV-related stigma and hazardous drinking among persons living with HIV/AIDS. Stigma and Health.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline to 3-month follow-up
Primary	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.	Change from baseline to 3-month follow-up
Primary	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.	Change from baseline to 3-month follow-up
Primary	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.	Change from baseline to 3-month follow-up
Secondary	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.	Change from baseline to 3-month follow-up
Secondary	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.	Change from baseline to 3-month follow-up
Secondary	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).	Change from baseline to 3-month follow-up
Secondary	Viral load measures	Viral load measures will be determined through chart review with permission from the research participant.	Change from baseline to 3-month follow-up
Secondary	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.	Change from baseline to 3-month follow-up
Secondary	Quality of Life	We will also assess HIV-related quality of life with the validated World Health Organization (WHO) HIV Quality of Life measure.	Change from baseline to 3-month follow-up