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

NCT ID: NCT00503230

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

Tobacco Dependence; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care Intervention (SCI)

Group Type: ACTIVE_COMPARATOR

Standard Care Intervention (SCI)

Intervention Type: BEHAVIORAL

Standard Care Intervention (SCI)

Culturally Tailored Intervention (CTI)

Group Type: ACTIVE_COMPARATOR

Culturally Tailored Intervention (CTI)

Intervention Type: BEHAVIORAL

Culturally Tailored Intervention (CTI)

Interventions

Standard Care Intervention (SCI)

Standard Care Intervention (SCI)

Intervention Type: BEHAVIORAL

Culturally Tailored Intervention (CTI)

Culturally Tailored Intervention (CTI)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cassandra Stanton, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital/Brown University

Locations

Lowell Community Health Center

Lowell, Massachusetts, United States

Greater New Bedford Community Center

New Bedford, Massachusetts, United States

Dimock Community Health Center

Roxbury, Massachusetts, United States

Family Health Center of Worcester

Worcester, Massachusetts, United States

Montefiore Medical Center

The Bronx, New York, United States

Rhode Island Hospital HIV Clinic

Providence, Rhode Island, United States

Butler Hospital

Providence, Rhode Island, United States

The Miriam Hospital Immunology Clinic

Providence, Rhode Island, United States

Countries

United States

References

Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

Reference Type: DERIVED

PMID: 39868569 (View on PubMed)

Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.

Reference Type: DERIVED

PMID: 39101506 (View on PubMed)

Other Identifiers

R01DA018079

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA018079

Identifier Type: NIH

Identifier Source: org_study_id

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