N/A
N=294
Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings
HIV · Alcohol Use · Medication Adherence
Bottom Line
View on ClinicalTrials.gov: NCT02390908 ↗Enrolled (actual)
294
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Viral Load — 3.1; 1.8; 1.8; 2.6 Log-transformed copies per. milimeter — p=0.39
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Immediate PLUS intervention (Behavioral); Wait-list PLUS intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hunter College of City University of New York
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Load |
3.1; 1.8; 1.8; 2.6; 2.5 | 0.39 |
| PRIMARY CD4 Count |
632.4; 696.2; 390.5; 398.2; 409.1 | 0.95 |
| PRIMARY ART Medication Adherence |
85.5; 86.6; 83.4; 77.6 | 0.22 |
| PRIMARY Alcohol Use Severity |
10.38; 3.29; 9.05; 5.93 | 0.02 sig |
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.
Eligibility Criteria
Inclusion Criteria
- HIV-positive
- Currently receiving ART
- Current viral load (VL) ˃200 copies/ml
- Report drinking at hazardous levels, operationalized as exceeding 14 standard drinks per week for men or exceeding 7 standard drinks per week for women, or reported use of illicit drugs exclusive of marijuana or illicit use of prescription opioids within the past 3 months.
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT02390908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.