NCT00503230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

5.8 years

First QC Date

July 17, 2007

Last Update Submit

May 2, 2013

Conditions

Tobacco DependenceHIV Infections

Keywords

tobaccosmokingHIVLatino

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation

    6 and 12 months

Study Arms (2)

Standard Care Intervention (SCI)

ACTIVE COMPARATOR
Behavioral: Standard Care Intervention (SCI)

Culturally Tailored Intervention (CTI)

ACTIVE COMPARATOR
Behavioral: Culturally Tailored Intervention (CTI)

Interventions

Standard Care Intervention (SCI)BEHAVIORAL

Standard Care Intervention (SCI)

Standard Care Intervention (SCI)
Culturally Tailored Intervention (CTI)BEHAVIORAL

Culturally Tailored Intervention (CTI)

Culturally Tailored Intervention (CTI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Lowell Community Health Center

Lowell, Massachusetts, 01854, United States

Location

Greater New Bedford Community Center

New Bedford, Massachusetts, 02740, United States

Location

Dimock Community Health Center

Roxbury, Massachusetts, 02129, United States

Location

Family Health Center of Worcester

Worcester, Massachusetts, 01610, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Rhode Island Hospital HIV Clinic

Providence, Rhode Island, 02903, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

The Miriam Hospital Immunology Clinic

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

  • 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.

    PMID: 39868569DERIVED

  • 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.

    PMID: 39101506DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderHIV InfectionsSmoking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Officials

  • Cassandra Stanton, Ph.D.

    Butler Hospital/Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

October 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

US(8)