NCT03935945

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

May 2, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

January 10, 2018

Last Update Submit

May 1, 2019

Conditions

Alcohol Consumption

Keywords

DrinkingAlcoholHIV+

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Sexual behavior

    Change from baseline to 3-month follow-up

  • Alcohol-related sexual behavior

    Change from baseline to 3-month follow-up

  • Medication Adherence

    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

  • +1 more secondary outcomes

Study Arms (2)

Personalized Feedback Intervention (PFI)

EXPERIMENTAL

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

Behavioral: Personalized Feedback Intervention

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.

Interventions

Personalized Feedback InterventionBEHAVIORAL

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

Personalized Feedback Intervention (PFI)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Unwillingness to participate
  • Failure to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Street Health Center

Houston, Texas, 77009, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30034300BACKGROUND

  • 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.

    PMID: 27497249BACKGROUND

  • 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.

    PMID: 31777759BACKGROUND

  • 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.

    PMID: 27546879BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Central Study Contacts

Clayton Neighbors, PhD

CONTACT

713-743-2616cneighbors@uh.edu

Joanne Angosta, BA

CONTACT

jangosta@central.uh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Moores Professor and Director of Social Psychology Program

Study Record Dates

First Submitted

January 10, 2018

First Posted

May 2, 2019

Study Start

January 20, 2018

Primary Completion

November 30, 2019

Study Completion

January 31, 2020

Last Updated

May 2, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)