NCT00551720

Brief Summary

The purpose of this study is to develop and evaluate a brief, clinic-based smoking cessation treatment for an HIV+ population. We compared two treatments, a brief advice and follow-up plus nicotine patch treatment(Standard Care; SC) and brief advice and follow-up, nicotine patch, with the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation (Motivationally-Enhanced; ME), in a randomized controlled trial. We hypothesized that those HIV+ participants receiving the ME will demonstrate greater biochemically verified smoking abstinence rates at 6-month follow-up than those receiving the SC control treatment. All study participants were 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
444

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_3 hiv-infections

Geographic Reach
1 country

5 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

January 1, 1999

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2007

First QC Date

October 30, 2007

Last Update Submit

January 11, 2017

Conditions

HIV InfectionsSmoking Cessation

Keywords

HIVHIV positiveAIDSsmoking cessationsmokingsmoking counseling

Outcome Measures

Primary Outcomes (1)

  • smoking cessation

    6-months

Secondary Outcomes (1)

  • smoking cessation

    2- and 4-months

Study Arms (2)

Standard Care

EXPERIMENTAL
Behavioral: Standard Care

Motivational Enhancement

EXPERIMENTAL
Behavioral: Motivational Enhancement

Interventions

Standard CareBEHAVIORAL

Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch

Standard Care
Motivational EnhancementBEHAVIORAL

Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.

Motivational Enhancement

Eligibility Criteria

Age18 Years - 70 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
  • Be 18 years old or older
  • Be current (past 7 days) cigarette smoker
  • 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 with quitting 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 (5)

Stanley Street Treatment and Resources, Inc.

Fall River, Massachusetts, 02720, United States

Location

Greater New Bedford Community Center

New Bedford, Massachusetts, 02740, United States

Location

Hope Center for HIV Care, Memorial Hospital

Pawtucket, Rhode Island, 02906, United States

Location

Rhode Island Hospital HIV Clinic

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital Immunology Clinic

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

  • 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

  • Lloyd-Richardson EE, Stanton CA, Papandonatos GD, Shadel WG, Stein M, Tashima K, Flanigan T, Morrow K, Neighbors C, Niaura R. Motivation and patch treatment for HIV+ smokers: a randomized controlled trial. Addiction. 2009 Nov;104(11):1891-900. doi: 10.1111/j.1360-0443.2009.02623.x. Epub 2009 Aug 28.

    PMID: 19719796DERIVED

MeSH Terms

Conditions

HIV InfectionsSmoking CessationHIV SeropositivityAcquired Immunodeficiency SyndromeSmoking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHealth BehaviorBehaviorSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Raymond Niaura, PhD

    Brown University-Butler Hospital

    PRINCIPAL INVESTIGATOR

  • Elizabeth Lloyd-Richardson, PhD

    Brown University/The Miriam Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

January 1, 1999

Study Completion

December 1, 2004

Last Updated

January 12, 2017

Record last verified: 2007-10

Locations

US(5)