CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 158 enrolled
Drug / intervention
Varenicline +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01898195
NCT01898195N/ACompleted

Improving Adherence to Smoking Cessation Medication Among PLWHA

NYU Langone Health·interventional·Posted Jul 12, 2013·Updated Aug 18, 2017

In Brief

A clinical study evaluating Varenicline, Text Message, and 1 other intervention for Tobacco Use Cessation. Completed, enrolled 158 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2013
Enrollment StartMar 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.0 years ago

Interventions

Vareniclinedrug

Varenicline will be provided for three months.

Text Messagebehavioral

Text messages will be developed twice daily for three months

Adherence Behavioral Therapybehavioral

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