Reducing Ethnic Health Disparities: Motivating HIV+ Latinos to Quit Smoking (AURORA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00503230
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : May 3, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Butler Hospital

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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence HIV Infections Behavioral: Standard Care Intervention (SCI) Behavioral: Culturally Tailored Intervention (CTI) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Ethnic Health Disparities: Motivating HIV+ Latinos to Quit Smoking
Study Start Date : October 2005
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Smoking

Arm Intervention/treatment
Active Comparator: Standard Care Intervention (SCI) Behavioral: Standard Care Intervention (SCI)
Standard Care Intervention (SCI)

Active Comparator: Culturally Tailored Intervention (CTI) Behavioral: Culturally Tailored Intervention (CTI)
Culturally Tailored Intervention (CTI)

Primary Outcome Measures :
  1. Smoking Cessation [ Time Frame: 6 and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00503230

United States, Massachusetts
Lowell Community Health Center
Lowell, Massachusetts, United States, 01854
Greater New Bedford Community Center
New Bedford, Massachusetts, United States, 02740
Dimock Community Health Center
Roxbury, Massachusetts, United States, 02129
Family Health Center of Worcester
Worcester, Massachusetts, United States, 01610
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Rhode Island
Rhode Island Hospital HIV Clinic
Providence, Rhode Island, United States, 02903
Butler Hospital
Providence, Rhode Island, United States, 02906
The Miriam Hospital Immunology Clinic
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Cassandra Stanton, Ph.D. Butler Hospital/Brown University

Responsible Party: Butler Hospital Identifier: NCT00503230     History of Changes
Other Study ID Numbers: R01DA018079 ( U.S. NIH Grant/Contract )
R01DA018079 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Butler Hospital:

Additional relevant MeSH terms:
HIV Infections
Tobacco Use Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders