A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

Phase 3

Completed

• Conditions: AIDS; HIV Infections; Smoking
• Interventions: Behavioral: Standard care; Behavioral: Positively Smoke Free

• Registration Number: NCT01106638
• Lead Sponsor: Montefiore Medical Center

Brief Summary

The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• HIV-infection
• current cigarette smoker
• high motivation to quit

Exclusion Criteria

• Pregnancy
• breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Advice to quit, smoking cessation brochure, offer of nicotine patch
Intensive behavioral intervention	Positively Smoke Free	Eight session, behavioral intervention targeting HIV-infected smokers

Primary Outcome Measures

Name	Time	Method
Three month point-prevalence abstinence from cigarettes	3 months post-intervention

Secondary Outcome Measures

Name	Time	Method
Three month continuous abstinence from cigarettes	Three months post-intervention

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States