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

HIV Infections Clinical Trial

— AURORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503230
• Other study ID #: R01DA018079
• Secondary ID: R01DA018079
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2007
• Last updated: May 2, 2013
• Start date: October 2005
• Est. completion date: July 2011

Study information

• Verified date: May 2013
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Tobacco Dependence

Intervention

Behavioral:
• Standard Care Intervention (SCI)
Standard Care Intervention (SCI)
• Culturally Tailored Intervention (CTI)
Culturally Tailored Intervention (CTI)

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Lowell Community Health Center	Lowell	Massachusetts
United States	Greater New Bedford Community Center	New Bedford	Massachusetts
United States	Butler Hospital	Providence	Rhode Island
United States	Rhode Island Hospital HIV Clinic	Providence	Rhode Island
United States	The Miriam Hospital Immunology Clinic	Providence	Rhode Island
United States	Dimock Community Health Center	Roxbury	Massachusetts
United States	Family Health Center of Worcester	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation		6 and 12 months	No