BAPS in Botswana: The Thotloetso Trial

NCT04532970 | Completed DMC

• 2 other identifiers: 14025R01DA045604
• Study Type: interventional
• Target: 651
• Locations: 1 country
• Sites: 1

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)

Conditions

HIV Infections; Smoking Cessation; Smoking

Keywords

Botswana; Smoking cessation; BAPS; Counseling; HIV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard

PLACEBO COMPARATOR

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

BAPS

EXPERIMENTAL

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

Interventions

Cessation Counseling BEHAVIORAL

Two different types of smoking cessation counseling

BAPS; Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Botswana: collaborator

Study Sites (1)

University of Botswana

Gaborone, Botswana

Location

MeSH Terms

Conditions

HIV Infections; Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology Co-Director, Center for AIDS Research, Penn/CHOP/Wistar

Model Details: We will use permuted block randomization with random block sizes between 6 and 9 and stratified by sex and depressive symptoms. The blocks will ensure near 1:1 balance throughout the study. The random block sizes will protect against selection bias by preventing staff from predicting which intervention any one individual will be assigned. We will stratify by sex to ensure balance of women in both arms since smoking is more common in men. We will stratify by depressive symptoms to ensure balance in testing whether the effect of BAPS is differential between those with and without greater degrees of distress. While a Mood Module of PRIME-MD score of \>5 symptoms is commonly used as a threshold for depression (Spitzer et al., 1994), we are also targeting lower level symptoms with this intervention having found that lower levels are associated with health behaviors such as medication adherence (Gross et al., 2017).

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 31, 2020
• Study Start: May 6, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

BO (1)