HIV InfectionsBOTSNCT04532970
BAPS in Botswana: The Thotloetso Trial
A study testing Cessation Counseling in people with HIV Infections and Smoking Cessation, run by Abramson Cancer Center at Penn Medicine at 1 site in Botswana.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Smoking Cessation, Smoking
- What is being tested?
- Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 651 participants
- Where
- 1 siteBotswana
- Study dates
- 6 May 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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
- Being tested
- Cessation Counseling
- Keywords
- Botswana, Smoking cessation, BAPS, Counseling, HIV
- Medical subject headings
- HIV Infections, Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation CounselingBehavioural
Two different types of smoking cessation counseling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
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)
Measured: At week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start6 May 2021
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Botswana
- Responsible party
- Principal investigator, Robert Gross, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532970
- Sponsor's protocol ID
- 14025
- Other IDs
- R01DA045604
- Acronym
- BOTS
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2020
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Investigators may request access to the dataset after ethics approval by stakeholders in Botswana.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Combination of Behavioral Activation and Problem Solving as a Novel Behavioral Smoking Cessation Intervention for Smokers With HIV in Botswana
- ClinicalTrials.gov ID
- NCT04532970
- Acronym / sponsor ID
- BOTS / 14025
- Conditions
- HIV Infections, Smoking Cessation, Smoking
- Keywords
- Botswana, Smoking cessation, BAPS, Counseling, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Botswana
- Study start
- 6 May 2021 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Standard | Placebo comparator | Behavioral: Cessation CounselingEligible 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. |
| BAPS | Experimental | Behavioral: Cessation CounselingKey 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cessation CounselingTwo different types of smoking cessation counseling | Behavioural | BAPS, Standard |
Primary outcome
Smoking Cessation
Time frame: At week 26
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Investigators may request access to the dataset after ethics approval by stakeholders in Botswana.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cessation Counseling in people with HIV Infections and Smoking Cessation, run by Abramson Cancer Center at Penn Medicine at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: At week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.