Recruiting

Personalized Feedback Intervention

Sponsor:

University of Houston

Code:

NCT03935945

Conditions

Alcohol Consumption

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Personalized Feedback Intervention

Study Details

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.

Conditions

Alcohol Consumption

Study ID

NCT03935945

Start date

Jan 20, 2018

Status verified date

May, 2019

Completion date

Jan 31, 2020

Anticipated

Primary completion date

Nov 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Personalized Feedback Intervention (PFI)

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

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.

Interventions

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

Primary outcome measure

  • Typical weekly drinking [ Time Frame: Change from baseline to 3-month follow-up ]
  • Quantity of Alcohol Consumed in Single Occasion [ Time Frame: Change from baseline to 3-month follow-up ]
  • Problematic Drinking [ Time Frame: Change from baseline to 3-month follow-up ]
  • Consequences [ Time Frame: Change from baseline to 3-month follow-up ]

Central Contacts and Locations

Central contacts

Clayton Neighbors, PhD

713-743-2616cneighbors@uh.edu

Joanne Angosta, BA

jangosta@central.uh.edu

Locations

Thomas Street Health Center

Recruiting

Houston, Texas, United States, 77009

Contacts

Thomas P Giordano, MD

713-798-8918tpg@bcm.edu

Tanisha T Bell, MPH

(713) 873-4526darko@bcm.edu

More Information

Sponsor

University of Houston

Last update posted

May 2, 2019

Last verified

May, 2019

Keywords

  • Drinking
  • Alcohol
  • HIV+

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Houston on 2019-05-02.