NCT01898195

Brief Summary

Smoking rates among individuals living with HIV/AIDS range between 47% and 65%, a prevalence that is roughly three times the rate of the general population. This elevated prevalence is alarming given the increased likelihood of numerous adverse health outcomes experienced by HIV-positive smokers. Cigarette smoking is associated with greater levels of HIV-related symptom burden and appears to decrease the effectiveness of HAART as assessed by both viral load and CD4 counts (Vidrine 2009, Marshall 2009, Vidrine 2007, Miguez-Burbane 2005). PLWHA who smoke are also at increased risk of infections and noninfectious pulmonary complications and both AIDS-associated and non-AIDS-associated malignancies compared to nonsmokers. This study will refine and pilot test a theory-driven smoking cessation intervention that enhances existing behavioral approaches by testing the impact of text message reminders to take varenicline and the feasibility and additional impact of including adherence-focused behavioral cessation counseling. The investigators propose to randomize 190 participants, recruited from three HIV/AIDS clinic, to a three arm pilot study that compares: 1) Standard Care (SC), 2) SC + text message reminders, and 3) SC + text message reminders + cell phone-delivered adherence-focused behavioral therapy (ABT). Participants in all three arms will receive varenicline for 12 weeks. The primary outcomes are adherence to varenicline and biochemically validated smoking abstinence at 12 weeks and 3-month follow-up from the time of study enrollment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

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

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 18, 2017

Completed
Last Updated

August 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

July 1, 2013

Results QC Date

August 5, 2016

Last Update Submit

July 19, 2017

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

  • End-of-intervention Varenicline Adherence

    number of participants who took at least 80% prescribed dose since last interview, based on pill count

    4 Weeks

Secondary Outcomes (1)

  • End-of-intervention Smoking Abstinence

    7 Days

Study Arms (3)

Standard Care

ACTIVE COMPARATOR

Participants in this arm will receive varenicline for smoking cessation.

Drug: Varenicline

Standard Care + Text message

EXPERIMENTAL

Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.

Drug: VareniclineBehavioral: Text Message

Standard Care + Text Message + ABT

EXPERIMENTAL

Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions

Drug: VareniclineBehavioral: Text MessageBehavioral: Adherence Behavioral Therapy

Interventions

VareniclineDRUG

Varenicline will be provided for three months.

Also known as: Chantix
Standard CareStandard Care + Text Message + ABTStandard Care + Text message
Text MessageBEHAVIORAL

Text messages will be developed twice daily for three months

Standard Care + Text Message + ABTStandard Care + Text message
Adherence Behavioral TherapyBEHAVIORAL

Seven Adherence Behavioral Therapy sessions will given over a three month period

Also known as: ABT
Standard Care + Text Message + ABT

Eligibility Criteria

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

You may qualify if:

  • Current patient at one of two SLR CCC clinics with a designated physician (had intake visit and enrolled into clinic)
  • Age 18 years or older;
  • Current or regular smoker (\>5 cigarettes per day);
  • Carbon Monoxide (CO) monitor reading of \>8 ppm;
  • Willingness to set a quit date;
  • Able to conduct activities in English;
  • Ability to provide informed consent;
  • Willingness to carry/use a cell phone; AND
  • Eligible to take varenicline as determined by the patient's primary care provider

You may not qualify if:

  • Unstable cardiovascular disease (e.g. uncontrolled blood pressure, unstable angina, or myocardial infarction in the past 4 weeks);
  • Current homicidal or suicidal ideation, history of suicidal ideation, or history of psychosis;
  • Has a serious or untreated psychiatric illness (major depression, bipolar or schizophrenia);
  • Severe renal impairment (defined as having a creatinine clearance \< 30mL/min);
  • Currently using smokeless tobacco;
  • Currently using FDA-approved smoking cessation medication or other smoking cessation treatment and or participating in another smoking cessation program;
  • Active drug use identified by a score of 6 or above on DAST-10 Drug Abuse Screening Test;
  • Alcohol dependence or risk drinking identified by a score of 5 or above for men and 4 or above for women on AUDIT-C Alcohol Use Disorders Identification Test
  • Pregnant or nursing; AND/OR
  • Has a cognitive impairment that would preclude giving consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spencer Cox Center for Health

New York, New York, 10011, 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

  • Shelley D, Tseng TY, Gonzalez M, Krebs P, Wong S, Furberg R, Sherman S, Schoenthaler A, Urbina A, Cleland CM. Correlates of Adherence to Varenicline Among HIV+ Smokers. Nicotine Tob Res. 2015 Aug;17(8):968-74. doi: 10.1093/ntr/ntv068.

    PMID: 26180221DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Results Point of Contact

Title
Donna Shelley, MD, MPH/ Vice Chair for Research; Associate Professor of Population Health and Medici
Organization
Department of Population Health, New York University School of Medicine
Donna.Shelley@nyumc.org
646-501-2526

Study Officials

  • Donna Shelley, MD MPH

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 1, 2013

First Posted

July 12, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 18, 2017

Results First Posted

August 18, 2017

Record last verified: 2017-07

Locations

US(1)