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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00503230
First received: July 17, 2007
Last updated: May 2, 2013
Last verified: May 2013

July 17, 2007
May 2, 2013
October 2005
July 2011   (final data collection date for primary outcome measure)
Smoking Cessation [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Smoking Cessation [ Time Frame: 6 and 12 months ]
Complete list of historical versions of study NCT00503230 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Reducing Ethnic Health Disparities: Motivating HIV+ Latinos to Quit Smoking
Reducing Ethnic Health Disparities: Motivating HIV+ Latinos to Quit Smoking

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tobacco Dependence
  • HIV Infections
  • Behavioral: Standard Care Intervention (SCI)
    Standard Care Intervention (SCI)
  • Behavioral: Culturally Tailored Intervention (CTI)
    Culturally Tailored Intervention (CTI)
  • Active Comparator: Standard Care Intervention (SCI)
    Intervention: Behavioral: Standard Care Intervention (SCI)
  • Active Comparator: Culturally Tailored Intervention (CTI)
    Intervention: Behavioral: Culturally Tailored Intervention (CTI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00503230
R01DA018079, R01DA018079
Yes
Butler Hospital
Butler Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Cassandra Stanton, Ph.D. Butler Hospital/Brown University
Butler Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP