BAPS in Botswana: The Thotloetso Trial — BOTS  

HIV Infections Clinical Trial

Official title: Testing the Combination of Behavioral Activation and Problem Solving as a Novel Behavioral Smoking Cessation Intervention for Smokers With HIV in Botswana

Status Recruiting

Clinical Trial Summary

The main purpose of this research study is to compare traditional behavioral smoking cessation therapy with a different type of behavioral therapy-known as behavioral activation problem solving (BAPS)-for smoking cessation. Standard smoking cessation counseling (SC) focuses on self-monitoring, identifying smoking triggers and how to manage them, relaxation and social support for non-smoking, and relapse prevention. BAPS focuses on recognizing he feelings you are having that lead to smoking and how to overcome those feelings and focus on activities that discourage you from smoking and avoid activities that encourage you to smoke. Both counseling types include gathering information about your personal smoking patterns, your likes, dislikes, and other personal characteristics about your lifestyle.

Half of participants who enroll in the study will receive standard smoking cessation counseling (SC) and half will receive BAPS counseling. We will compare the rates of quitting smoking across the two groups at the end of treatment (study week 10), and 12 weeks after the end of treatment (study week 26)

Clinical Trial Description

Eligible patients will be randomized to one of the treatment arms, which will involve 5 phone-delivered counseling sessions over a 9-week treatment phase. While enrolled in this research study, you will also be asked not to use any smoking cessation treatment (including medication or behavioral therapy) other than that which is provided to you within the context of this clinical study.

The session will either be run by a study coordinator or a counselor. The study coordinator gathers information about you so we can understand whether or not the program is working. The study coordinator will be the person conducting the assessments. The counselor works with you to help you stop smoking.

Study visits are described in more detail below.

Intake

• Complete the study informed consent with a research staff member. You will have the opportunity to have your questions answered before signing the study consent form. If you chose not to sign this form, no procedures will be performed

• Complete a breath carbon monoxide (CO) assessment to measure your smoke exposure. Carbon monoxide is a poisonous gas that comprises less than 1% of the air we breathe and is also produced through smoking a cigarette. Your CO levels provide an indication of how much cigarette smoke you have been exposed to.

• Complete paper and pencil assessments of your demographics, alcohol and smoking history, smoking and health behaviors, and mood.

Weeks 1,3,5,7, and 9

• Phone-delivered counseling session (SC or BAPS) that will last between 30-60 min to help prepare you for your upcoming quit attempt (Week 2, Target Quit Day)

• These sessions will focus on reinforcing your success and reviewing your quit plan or on reestablishing another quit date and restarting the smoking cessation process

Weeks 10 and 26

• Assessments only, the same ones administered during the intake session

• If you are quit (have not smoked in the past 7 days), you will be asked to come in to provide a CO breath sample ;

Related Conditions & MeSH terms

• HIV Infections
• Smoking
• Smoking Cessation

• NCT number: NCT04532970
• Study type: Interventional
• Source: University of Pennsylvania
• Contact: Robert Gross, MD
• Phone: 215-898-2437
• Email: grossr@pennmedicine.upenn.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2021
• Completion date: July 1, 2025