NCT00502827

Brief Summary

The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
706

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

11.3 years

First QC Date

July 16, 2007

Last Update Submit

February 25, 2016

Conditions

Keywords

Human Immunodeficiency VirusHIV positiveHIV Positive SmokersAIDSCell Phone InterventionCPISmoking CessationInterview

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence

    1 year after quit date

Study Arms (2)

Recommended Standard of Care

OTHER

Recommended Standard of Care (RSOC) = Physician Advice + Written Materials

Other: Recommended Standard of Care

RSOC + Cell Phone Intervention

OTHER

Recommended Standard of Care (RSOC) + Cell Phone Intervention

Behavioral: Cell Phone InterventionOther: Recommended Standard of Care

Interventions

Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking.

Also known as: CPI
RSOC + Cell Phone Intervention

Advice from your physician to stop smoking and written materials designed to help you quit smoking.

Also known as: RSOC
RSOC + Cell Phone InterventionRecommended Standard of Care

Eligibility Criteria

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

You may qualify if:

  • HIV-positive
  • years of age or older
  • Current, regular smoker (\> 5 cigarettes per day for the past 30 days, breath CO of \> 7ppm)
  • English or Spanish speaking
  • Able to provide written informed consent to participate
  • Willing to set a quit date within 1 week of baseline assessment

You may not qualify if:

  • Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
  • Current participation in another smoking cessation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thomas Street Clinic

Houston, Texas, 77009, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, 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.

  • Buchberg MK, Gritz ER, Kypriotakis G, Arduino RC, Vidrine DJ. The role of BMI change on smoking abstinence in a sample of HIV-infected smokers. AIDS Care. 2016;28(5):603-7. doi: 10.1080/09540121.2015.1120854. Epub 2015 Dec 15.

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV SeropositivitySmoking Cessation

Interventions

cyclopropapyrroloindole

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHealth BehaviorBehavior

Study Officials

  • Damon Vidrine, MS, DRPH, BA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

January 1, 2004

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations