Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic

NCT ID: NCT03935945

Last Updated: 2019-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Consumption

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Personalized Feedback Intervention (PFI)

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

Group Type EXPERIMENTAL

Personalized Feedback Intervention

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

* Unwillingness to participate
* Failure to provide consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baylor College of Medicine

OTHER

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clayton Neighbors

Moores Professor and Director of Social Psychology Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Thomas Street Health Center

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Clayton Neighbors, PhD

Role: CONTACT

713-743-2616

Joanne Angosta, BA

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thomas P Giordano, MD

Role: primary

713-798-8918

Tanisha T Bell, MPH

Role: backup

(713) 873-4526

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30034300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27497249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31777759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27546879 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

uhouston

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Promoting Employment in Persons Living With HIV/AIDS
NCT03959826 ACTIVE_NOT_RECRUITING NA