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NCT01898195 · ClinicalTrials.gov registry record · NA

Improving Adherence to Smoking Cessation Medication Among PLWHA

A NA study of Tobacco Use Cessation, sponsored by NYU Langone Health.

Completed
Registry status
NA
Development phase
158
Enrollment target
1
Study location

NCT01898195 is a NA study of Tobacco Use Cessation that has completed, run by NYU Langone Health. The registered enrollment target is 158 participants, below the 880-participant average among 36 other Tobacco Use Cessation trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01898195, a NA study of Tobacco Use Cessation, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
NA
Development phase
158 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Varenicline
  • BEHAVIORAL Text Message
  • BEHAVIORAL Adherence Behavioral Therapy

Study Locations (1)

New York

  • Spencer Cox Center for Health - New York

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2013-03
Est. Completion 2014-12
Phase NA

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT01898195

The ClinicalTrials.gov registry entry for NCT01898195 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 880-participant average among 36 other Tobacco Use Cessation trials with a reported enrollment target (82% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tobacco Use Cessation appearing as the primary indexed condition, and to 3 interventions - of which Varenicline is the first listed.

NCT01898195 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01898195 about?

NCT01898195 is a clinical study titled "Improving Adherence to Smoking Cessation Medication Among PLWHA". 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. Ci...

What is the current status of trial NCT01898195?

This trial is currently completed. It is a NA study. The enrollment target is 158 participants. The study started on 2013-03. Estimated completion is 2014-12.

What conditions does trial NCT01898195 study?

This clinical trial studies the following conditions: Tobacco Use Cessation.

What interventions are being tested in trial NCT01898195?

The interventions under investigation include: Varenicline (DRUG), Text Message (BEHAVIORAL), Adherence Behavioral Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT01898195?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01898195 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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