Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02390908
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2015-03-06
Brief Title:
Improving HIV and Alcohol-Related Outcomes Among HIV Persons in Clinic Settings
Sponsor:
Hunter College of City University of New York
Organization:
Hunter College of City University of New York
Study Overview
Official Title:
Improving HIV and Alcohol-Related Outcomes Among HIV Persons in Clinic Settings
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
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:
PLUS
Brief 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 HIVviral 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
Detailed Description:
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 interventions 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
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 interventions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA022302 | NIH | None | httpsreporternihgovquickSearchR01AA022302 |