Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/28/2018 |
| Start Date: | August 1, 2013 |
| End Date: | May 8, 2018 |
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 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 ART-adherence 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, CUNY and the Spencer Cox Center for Health at the Institute for
Advanced Medicine, Mount Sinai Health System.
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 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 ART-adherence 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, CUNY and the Spencer Cox Center for Health at the Institute for
Advanced Medicine, Mount Sinai Health System.
Alcohol consumption at harmful or hazardous levels among HIV-positive persons exacerbates
health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) has
been the single most important treatment for people living with HIV to optimize viral
suppression and slow disease progression. Adherence to ART has considerable public health
implications, particularly given that optimal adherence decreases morbidity and mortality,
decreases the potential for the development of drug resistant strains of HIV, and reduces HIV
infectiousness.
Project PLUS (Positive Living through Understanding and Support) was the first (and to our
knowledge only) theory-based behavioral intervention, which integrates motivational
interviewing and cognitive-behavioral skills training, to demonstrate significant
improvements in viral load, CD4 cell count, and self-reported adherence among a racially and
ethnically diverse sample of HIV-positive women and men enrolled in a randomized controlled
trial, and the first intervention for hazardous drinkers to demonstrate any significant
effects. A clinic-based replication is the crucial next step in studying the intervention's
effectiveness in the real world when delivered by HIV clinic providers to their patients.
In collaboration with medical providers at the Spencer Cox Center for Health at the Institute
for Advanced Medicine, Mount Sinai Health System, the largest provider of HIV medical care in
the New York City area, our goals are to better understand alcohol-related outcomes among
HIV-positive persons over the lifespan and to conduct a multisite comparative effectiveness
trial with three intensities of treatment—the PLUS intervention, an enhanced treatment as
usual (eTAU) condition, and treatment as usual (TAU) condition—to test the clinical and
cost-effectiveness of the PLUS intervention in reducing alcohol use and improving ART
adherence, viral load, and CD4 counts among HIV-positive hazardous drinkers. This study has
the potential to exert a sustained and powerful impact on the effectiveness of ART
interventions for HIV-positive persons with problematic drinking.
health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) has
been the single most important treatment for people living with HIV to optimize viral
suppression and slow disease progression. Adherence to ART has considerable public health
implications, particularly given that optimal adherence decreases morbidity and mortality,
decreases the potential for the development of drug resistant strains of HIV, and reduces HIV
infectiousness.
Project PLUS (Positive Living through Understanding and Support) was the first (and to our
knowledge only) theory-based behavioral intervention, which integrates motivational
interviewing and cognitive-behavioral skills training, to demonstrate significant
improvements in viral load, CD4 cell count, and self-reported adherence among a racially and
ethnically diverse sample of HIV-positive women and men enrolled in a randomized controlled
trial, and the first intervention for hazardous drinkers to demonstrate any significant
effects. A clinic-based replication is the crucial next step in studying the intervention's
effectiveness in the real world when delivered by HIV clinic providers to their patients.
In collaboration with medical providers at the Spencer Cox Center for Health at the Institute
for Advanced Medicine, Mount Sinai Health System, the largest provider of HIV medical care in
the New York City area, our goals are to better understand alcohol-related outcomes among
HIV-positive persons over the lifespan and to conduct a multisite comparative effectiveness
trial with three intensities of treatment—the PLUS intervention, an enhanced treatment as
usual (eTAU) condition, and treatment as usual (TAU) condition—to test the clinical and
cost-effectiveness of the PLUS intervention in reducing alcohol use and improving ART
adherence, viral load, and CD4 counts among HIV-positive hazardous drinkers. This study has
the potential to exert a sustained and powerful impact on the effectiveness of ART
interventions for HIV-positive persons with problematic drinking.
Inclusion Criteria:
- HIV-positive
- Currently receiving ART
- Current 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
Exclusion Criteria:
We found this trial at
1
site
New York, New York 10001
Phone: 212-206-7919
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