BAPS in Botswana: The Thotloetso Trial (BOTS)

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

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)

Study Overview

• Status: Completed
• Conditions: HIV Infections; Smoking; Smoking Cessation
• Intervention / Treatment: Behavioral: Cessation Counseling

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

• Study Type: Interventional
• Enrollment (Actual): 651
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Botswana
  • Gaborone, Botswana
    • University of Botswana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: Cessation Counseling; Two different types of smoking cessation counseling
Experimental: 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.	Behavioral: Cessation Counseling; Two different types of smoking cessation counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	be 7-day point prevalence abstinence at week 26 (24-weeks post-TQD; self-reported abstinence for 7 days prior to the assessment and breath CO ≤8 ppm)	At week 26, EOT

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: National Institute on Drug Abuse (NIDA); University of Botswana

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Counseling; HIV; Smoking cessation; Botswana; BAPS
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Behavior; Health Behavior; HIV Infections; Smoking; Smoking Cessation
• Other Study ID Numbers: 14025; R01DA045604 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Investigators may request access to the dataset after ethics approval by stakeholders in Botswana.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No