Reducing Ethnic Health Disparities: Motivating HIV+ Latinos to Quit Smoking (AURORA)
Primary Purpose
Tobacco Dependence, HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Standard Care Intervention (SCI)
Culturally Tailored Intervention (CTI)
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Dependence focused on measuring tobacco, smoking, HIV, Latino
Eligibility Criteria
Inclusion Criteria:
- Be receiving care for HIV at one of the participating immunology clinics
- Self-identify as being Latino/Hispanic (defined as being 1st, 2nd or 3rd generation from any of the Spanish-speaking countries of North America, Central America, South America and the Caribbean).
- Be 18 years old or older.
- Be current smokers of cigarettes (past 7 days)
- Speak English or Spanish
Exclusion Criteria:
- Are pregnant or nursing
- Have uncontrolled hypertension
- Use other forms of tobacco like cigars or chewing tobacco or are using anything else to help them quit smoking
- Are allergic to the nicotine patch or have a skin condition like eczema or psoriasis that makes them unable to use the patch
Sites / Locations
- Lowell Community Health Center
- Greater New Bedford Community Center
- Dimock Community Health Center
- Family Health Center of Worcester
- Montefiore Medical Center
- Rhode Island Hospital HIV Clinic
- Butler Hospital
- The Miriam Hospital Immunology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard Care Intervention (SCI)
Culturally Tailored Intervention (CTI)
Arm Description
Outcomes
Primary Outcome Measures
Smoking Cessation
Secondary Outcome Measures
Full Information
NCT ID
NCT00503230
First Posted
July 17, 2007
Last Updated
May 2, 2013
Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00503230
Brief Title
Reducing Ethnic Health Disparities: Motivating HIV+ Latinos to Quit Smoking
Acronym
AURORA
Official Title
Reducing Ethnic Health Disparities: Motivating HIV+ Latinos to Quit Smoking
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to develop and evaluate a brief clinic-based culturally tailored smoking cessation treatment for a largely low-income, Latino, HIV+ population. We will compare this Culturally-Tailored Intervention (CTI) that incorporates a strong social support component and is targeted to the special needs and concerns of a Latino population to a Standard Care Intervention (SCI) control condition, in a randomized controlled trial. We hypothesize that those Latinos receiving the CTI will demonstrate greater biochemically verified smoking abstinence rates at 12-months post-baseline than those receiving the SCI control treatment. All study participants and their participating social supports will be offered use of the nicotine patch.
Detailed Description
Advances in the treatment of HIV-disease have shown dramatic effects on improving immune function in a significant proportion of people infected with HIV in the United States. For the first time since the beginning of the HIV epidemic, individuals with HIV are faced with the prospect of living longer, healthier lives. Cigarette smoking is highly prevalent among HIV+ individuals and, in addition to the negative health consequences commonly resulting from smoking, poses unique health risks to those with HIV. Our present research investigation, Positive PATHS (PATHS), the only NIH-funded smoking cessation study in HIV+ persons, is designed to evaluate a clinic-based motivational smoking cessation intervention among HIV+ smokers in Southern New England. Preliminary analysis of the PATHS investigation indicate that both a standard care intervention (brief advice and NRT) and a more extensive motivational counseling condition have similar biochemically verified smoking abstinence rates 6-months post intervention, with Latino participants responding better to the brief standard care condition. The goal of the current application is to expand upon the preliminary results of this study and target the standard care intervention to Latino HIV+ patients who were found to respond best to a brief directive approach. This expanded standard care approach will incorporate the use of culturally specific materials to provide brief advice to both the patient and a patient-identified social support person who will be trained in ways to support cessation efforts. Latinos are a population greatly affected by HIV and tobacco use, yet rarely discussed in existing research. Most tobacco research that includes Latinos has focused on prevention efforts. The few culturally specific cessation interventions that have been done have focused mostly on Mexicans in the Southwest and California1,2,3. Considering the diversity of the Latino population in the US, those interventions may not generalize to Latinos in the Northeast, who are mostly of Puerto Rican and Dominican origin. Research is limited in the area of HIV among Latinos and there are no studies to date that address the problem of tobacco use among HIV+ Latinos. We propose to address this disparity by focusing this particular research study on Latino men and women living with HIV/AIDS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, HIV Infections
Keywords
tobacco, smoking, HIV, Latino
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care Intervention (SCI)
Arm Type
Active Comparator
Arm Title
Culturally Tailored Intervention (CTI)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Standard Care Intervention (SCI)
Intervention Description
Standard Care Intervention (SCI)
Intervention Type
Behavioral
Intervention Name(s)
Culturally Tailored Intervention (CTI)
Intervention Description
Culturally Tailored Intervention (CTI)
Primary Outcome Measure Information:
Title
Smoking Cessation
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be receiving care for HIV at one of the participating immunology clinics
Self-identify as being Latino/Hispanic (defined as being 1st, 2nd or 3rd generation from any of the Spanish-speaking countries of North America, Central America, South America and the Caribbean).
Be 18 years old or older.
Be current smokers of cigarettes (past 7 days)
Speak English or Spanish
Exclusion Criteria:
Are pregnant or nursing
Have uncontrolled hypertension
Use other forms of tobacco like cigars or chewing tobacco or are using anything else to help them quit smoking
Are allergic to the nicotine patch or have a skin condition like eczema or psoriasis that makes them unable to use the patch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassandra Stanton, Ph.D.
Organizational Affiliation
Butler Hospital/Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lowell Community Health Center
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Facility Name
Greater New Bedford Community Center
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Dimock Community Health Center
City
Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Family Health Center of Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Rhode Island Hospital HIV Clinic
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
The Miriam Hospital Immunology Clinic
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reducing Ethnic Health Disparities: Motivating HIV+ Latinos to Quit Smoking
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