BAPS in Botswana: The Thotloetso Trial

NCT ID: NCT04532970

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2025-12-01

Brief 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)

Detailed 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

Conditions

HIV Infections; Smoking Cessation; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard

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. SC will be based on the 2008 PHS Clinical Practice Guideline (Fiore et al., 2008) and on SC in our ongoing two-site trials (R01DA025078; R01CA165001) This intervention arm will begin with a "pre-quit" session designed to help participants prepare for their Target Quit Day (TDQ). The TQD session will occur at week 1. The SC arm will focus on self-monitoring, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, relapse prevention, and homework. The pre-quit session prepares participants for their TQD by reviewing their experience with quitting, beliefs about smoking/quitting, perceived barriers to cessation, and creating a quit plan to identify smoking triggers and implement alternative strategies to manage those triggers without smoking.

Group Type: PLACEBO_COMPARATOR

Cessation Counseling

Intervention Type: BEHAVIORAL

Two different types of smoking cessation counseling

BAPS

Key components of BAPS include activity monitoring and rewarding activity scheduling, assessment of personal goals and values, assessment and altering of avoidance behavior and other maladaptive coping strategies, and contingency management. BAPS focuses on reducing stress pile-up and loss of pleasure that accompanies the cessation process and on identifying and establishing environmental/social changes to promote abstinence. BAPS addresses smoking as a behavior that prevents and restricts opportunities for contact with healthy rewarding behaviors. These changes are achieved through altering daily routines previously associated with smoking in ways that increase pleasure and mastery across life domains, reducing rumination, and increasing behavioral skills to prevent return to smoking as a means of avoiding stressors.

Group Type: EXPERIMENTAL

Cessation Counseling

Intervention Type: BEHAVIORAL

Two different types of smoking cessation counseling

Interventions

Cessation Counseling

Two different types of smoking cessation counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• >18 years old
• Smoking cigarettes daily for the past 30 days
• HIV+ with HIV viral load of <1000 copies/mL, obtained within the 6 months prior to enrollment
• Receiving HIV care at Infectious Diseases Care Clinics (IDCCs) in and around Gaborone
• Able to communicate in English OR Setswana and provide written informed consent
• Planning on residing in the geographic area for at least the next 7 months

Exclusion Criteria

• Cognitive deficits that impair their ability to provide informed consent
• Current untreated and unstable diagnosis of alcohol dependence (if past use and stable for >30 days, eligible)
• Psychosis
• Use of chewing tobacco, snuff or snus
• Recent , current, or planned use (next 7 months) of nicotine substitutes or smoking cessation treatments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Botswana

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Robert Gross

Professor of Medicine and Epidemiology Co-Director, Center for AIDS Research, Penn/CHOP/Wistar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Botswana

Gaborone, , Botswana

Site Status: RECRUITING

Countries

Botswana

Central Contacts

Robert Gross, MD

Role: CONTACT

grossr@pennmedicine.upenn.edu

215-898-2437

Robert Schnoll, PhD

Role: CONTACT

schnoll@pennmedicine.upenn.edu

215-746-7143

Facility Contacts

Billy Tsima, MD MSCE

Role: primary

tsimab@ub.ac.bw

Other Identifiers

R01DA045604

Identifier Type: NIH

Identifier Source: secondary_id

View Link

842937

Identifier Type: -

Identifier Source: org_study_id