An interventional study of Cessation Counseling in HIV Infections, Smoking Cessation and Smoking, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in Botswana. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment
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)
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
Weeks 1,3,5,7, and 9
Weeks 10 and 26
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 651 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 460 studies on the registry; 87 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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)
Time frame: At week 26
Trained Research Assistants approached patients attending HIV clinics and asked if they currently smoke cigarettes. People who smoke were asked to complete a survey and provide identification. The participant's most recent plasma HIV RNA was ascertained from their medical record, or if unavailable, blood was obtained for assessment at a commercial laboratory. If they met study criteria, the participant was offered enrollment and written informed consent was obtained.
| Milestone | BAPS | Standard |
|---|---|---|
| Started | 328 | 323 |
| Completed | 273 | 266 |
| Not completed | 55 | 57 |
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)
| Participants | BAPS | Standard |
|---|---|---|
| Smoking Cessation | 122 | 125 |
Collected over Week 26. Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BAPS | 0/328 (0%) | 11/328 (3.4%) | 0/328 (0%) |
| Standard | 0/323 (0%) | 9/323 (2.8%) | 0/323 (0%) |
| Event | BAPS | Standard |
|---|---|---|
| miscarriagePregnancy, puerperium and perinatal conditions | 1/328 | 1/323 |
| short of breath, felt faintRespiratory, thoracic and mediastinal disorders | 0/328 | 1/323 |
| broken legInjury, poisoning and procedural complications | 0/328 | 1/323 |
| pneumoniaInfections and infestations | 0/328 | 1/323 |
| flu like symptomsInfections and infestations | 0/328 | 1/323 |
| drug overdoseInjury, poisoning and procedural complications | 0/328 | 1/323 |
| suicide attempt via pillsInjury, poisoning and procedural complications | 0/328 | 1/323 |
| nausea, vomiting, diarrheaGastrointestinal disorders | 0/328 | 1/323 |
| high virologic loadInfections and infestations | 1/328 | 1/323 |
| cough blood, dizziness, nauseaGastrointestinal disorders | 1/328 | 0/323 |
| Age, Continuous(years) | BAPS | Standard | Total |
|---|---|---|---|
| Median | 44 (38 to 49) | 44 (39 to 49) | 44 (38 to 49) |
| Sex: Female, Male(Participants) | BAPS | Standard | Total |
|---|---|---|---|
| Female | 57 | 53 | 110 |
| Male | 271 | 270 | 541 |
| Race and Ethnicity Not Collected(Participants) | BAPS | Standard | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| high depression(participants) | BAPS | Standard | Total |
|---|---|---|---|
| Number | 196 | 190 | 386 |
| hazardous alcohol use(participants) | BAPS | Standard | Total |
|---|---|---|---|
| Number | 56 | 74 | 130 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Investigators may request access to the dataset after ethics approval by stakeholders in Botswana.
Ran from May 2021 to primary completion in Dec 2025, 54 months.
Results were first posted in Oct 2026, 10 months after primary completion.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 54 months is above that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abramson Cancer Center at Penn Medicine →