CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 174 enrolled
Drug / intervention
Immediate PLUS intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02390908
NCT02390908N/ACompleted

Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings

Hunter College of City University of New York·interventional·Posted Mar 18, 2015·Updated Apr 12, 2021

In Brief

A clinical study evaluating Immediate PLUS intervention and Wait-list PLUS intervention for HIV and 2 related conditions. Completed, enrolled 174 participants across 1 site.

Detailed Summary

Alcohol use is increasingly recognized as a key factor in morbidity and mortality among HIV-positive individuals and represents an important public health concern, given its associations with medication non-adherence, increases in viral load, poor immunologic outcomes (lower cluster of differentiation 4, or CD4, counts), drug resistance, lower health care utilization, comorbidities (HIV/viral hepatitis coinfection), and poor health outcomes overall. Adherence to HIV medications has a double public health benefit, both in terms of slowing disease progression and improving health outcomes among HIV-positive individuals and in helping to curb the sexual transmission of HIV. The objective of this study is to implement a multisite comparative effectiveness trial in real-world clinical settings with three intensities of treatment to test the clinical and cost effectiveness of an efficacious, theory-based behavioral intervention (PLUS) in improving adherence to antiretroviral therapy (ART) and alcohol-related outcomes among HIV-positive individuals who drink alcohol at harmful or hazardous levels. The study is being conducted in collaboration between the Center for HIV Educational Studies and Training (CHEST) at Hunter College at the City University of New York (CUNY) and the Spencer Cox Center for Health at the Institute for Advanced Medicine, Mount Sinai Health System.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 18, 2015
Enrollment StartAug 1, 2013
Primary CompletionMay 8, 2018
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.3 years ago

Interventions

Immediate PLUS interventionbehavioral

The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.

Wait-list PLUS interventionbehavioral

In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.