Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03935945
Status:
UNKNOWN
Last Update Posted:
2019-05-02
First Post:
2018-01-10
Brief Title:
Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic
Sponsor:
University of Houston
Organization:
University of Houston
Study Overview
Official Title:
Personalized Feedback to Reduce HIV Hazardous Drinking in Primary Care
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor coping reasons
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 andor 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 ones 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None