Clinical Trials Directory

Trials / Completed

CompletedNCT00503230

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
400 (actual)
Sponsor
Butler Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStandard Care Intervention (SCI)Standard Care Intervention (SCI)
BEHAVIORALCulturally Tailored Intervention (CTI)Culturally Tailored Intervention (CTI)

Timeline

Start date
2005-10-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2007-07-18
Last updated
2013-05-03

Locations

8 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00503230. Inclusion in this directory is not an endorsement.