Smoking CessationPhase 4BSMARTNCT05694637
Botswana Smoking and Abstinence Reinforcement Trial
A Phase 4 study testing Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange) and Varenicline in people with Smoking Cessation and Hiv, run by University of Maryland, Baltimore at 15 sites in Botswana.
Trial summary
Many people living with HIV in southern Africa, specifically Botswana use tobacco products. Using tobacco makes some of the effects of HIV worse and even causes excess deaths. The investigators plan to use an intervention called Screening, Brief Intervention and Referral to Treatment (SBIRT) to help people to quit… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Hiv
- What is being tested?
- Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange) and Varenicline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 15 sitesBotswana
- Study dates
- 25 Jul 2023to 31 Aug 2027
- Phase
- Phase 4
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV infected
- Self reported current daily smoker
- Age 18 and older
- Engaged in HIV care as defined by being on ART for at least 6 months
- Willing/able to provide informed consent in English or Setswana
Who cannot join
- Less than 18 years of age
- Pregnant
- Unable or cognitively impaired to provide consent
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Botswana15 sites
Itekeng Clinic
Francistown, Central District
Masego Clinic
Francistown, Central District
Nyangabgwe Referral Hospital
Francistown, Central District
Goodhope Primary Hospital
Good Hope
Kanye Adventist Hospital
Kanye
Airstrip Clinic
Mahalapye, Central District
Mahalapye District Hospital
Mahalapye, Central District
Morwa Clinic
Mochudi, Central District
Palpye Primary Hospital
Palapye, Central District
Kediretswe Clinic
Palapye
Sefhare Primary Hospital
Sefhare, Central District
Sekgoma District Hospital
Serowe
Serowe Clinic
Serowe
Thamaga Primary Hospital
Thamaga, Kweneng District
Tutume Primary Hospital
Tutume, Central District
About this study
Many people living with HIV in southern Africa, specifically Botswana use tobacco products. Using tobacco makes some of the effects of HIV worse and even causes excess deaths. The investigators plan to use an intervention called Screening, Brief Intervention and Referral to Treatment (SBIRT) to help people to quit smoking and also a drug called varenicline. Apart from helping people to stop smoking, the investigators will also test to see how task shifting can be used to help people stop smoking in a sustainable way. Finally, the investigators will estimate the cost of the intervention.
Read the detailed description
The investigators will utilize a stepped wedge cluster randomized trial to implement BSMART. BSMART will be sequentially rolled out to 15 participating HIV treatment and care facilities assigned in three steps. Each step will provide data for a 12- month control/pre-implementation, a 12-month implementation, and a 12-month maintenance period. The investigators will stratify Botswana's HIV treatment and care facilities into three levels of facilities. The investigative team will randomly assign each of the three levels of facilities to one of three study steps. Each step will comprise (i.e. have representation) from 3 levels of facilities, giving each level of facilities the same probability of beginning the intervention at any step).
- Conditions
- Smoking Cessation, Hiv
- Being tested
- Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange), Varenicline
- Medical subject headings
- Smoking Cessation, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange)Behavioural
Trained LHWs will oversee the screening and brief intervention procedures (i.e., the 5As). A culturally acceptable standardized form will be integrated into intake procedures within the HIV that will allow for the documentation and results of using the 5As. The first "A" will be the screening question where the LHW will "Ask" study participants about smoking. When a participant reports being a smoker, the LHW will proceed to the next 3 "A"s (Advise, Assess, Assist). These 3As will constitute the brief intervention. The LHW will utilize motivational enhancing discussion between the study participant with a focus on increasing insight and awareness regarding smoking and motivation toward behavioral change. For those participants who are motivated for treatment, a referral will be made to a clinic nurse practitioner for evaluation for treatment with varenicline.
VareniclineDrug
Referral to treatment with varenicline will be provided to those identified as needing more than a brief intervention. Participants will initiate medication treatment with varenicline for smoking cessation with a quit date scheduled for day 8 following first study dose of the medication. Participants will meet with the study clinician at baseline who will provide medical clearance and sign off on prescription orders. All medication will be provided to participants by the study team. Participants will receive a weekly supply of medication for the first four weeks to ensure proper dosing and monitor for adverse events. For the subsequent 8 weeks, participants will return every 4 weeks to receive the next month's supply of medication. Dosage adjustments will be permitted in an effort to control adverse effects throughout the trial. This will allow us to balance internal validity with good clinical practice. Varenicline will be dosed in accordance with package labeling.
| Study group | Role | What they receive |
|---|---|---|
| SBIRT | Active comparator | Trained LHWs will oversee the screening and brief intervention procedures (i.e., the 5As). A culturally acceptable standardized form will be integrated into intake procedures within the HIV that will allow for the documentation and results of using the 5As. The first "A" will be the screening question where the LHW will "Ask" study participants about smoking. When a participant reports being a smoker, the LHW will proceed to the next 3 "A"s (Advise, Assess, Assist). These 3As will constitute the brief intervention. The LHW will utilize motivational enhancing discussion between the study participant with a focus on increasing insight and awareness regarding smoking and motivation toward behavioral change. For those participants who are motivated for treatment, a referral will be made to a clinic nurse practitioner for evaluation for treatment with varenicline. Receives: Behavioral: Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange); Drug: Varenicline |
| Standard of Care | No intervention | Trained LHWs will provide a brief motivation counseling and a brochure about smoking cessation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Abstinence will be based on self-reported 7-day point prevalence abstinence confirmed by expired CO<6 ppm. Abstinence criteria must be met in study month 6 or at an earlier study week and maintained through study month 6 to be considered a responder. We will use CO Check+ (MD Spiro), a single-breath point-of-care tool designed specifically for use in smoking cessation programs and clinics
Measured: Week 24
Secondary outcomes (1)
Adherence to medication
For those who agree to be treated with Varenicline, pill and counseling adherence were assessed at Weeks 0, 1, 2, 4, 8, and 12. Pill adherence will be tracked by the following question at each medication visit: How many days in the last week did you take at least one of your study pills 39. Pill adherence will be defined by participant self-report of taking 6 or 7 pills at week 8 which coincided with their last receipt of Varenicline.
Measured: Weeks 0, 1, 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start25 Jul 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a stepped wedge cluster randomization trial
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore County, University of Maryland, College Park, University of Chicago
- Responsible party
- Principal investigator, Man Charurat, University of Maryland, Baltimore
- Investigators
- Manhattan Charurat, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694637
- Sponsor's protocol ID
- HP-00102995
- Acronym
- BSMART
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2022
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansfield ME, Bada F, Mokonopi SV, Blanco N, Ikgopoleng K, Okui L, DiClemente C, Tapera R, Mbongwe B, Magidson J, Himelhoch S, Charurat M. A qualitative investigation of tobacco use and cessation experiences among people living with HIV in Botswana. Discov Public Health. 2026;23(1):1483. doi: 10.1186/s12982-026-02813-1. Epub 2026 Sep 18.
PubMed 42763466Bada F, Mansfield ME, Okui L, Montebatsi M, DiClemente C, Tapera R, Ikgopoleng K, Mokonopi S, Magidson JF, Onukwugha E, Ndwapi N, Himelhoch S, Mbongwe B, Charurat M. Design and rationale of the Botswana Smoking Abstinence Reinforcement Trial: a protocol for a stepped-wedge cluster randomized trial. Implement Sci Commun. 2024 May 8;5(1):53. doi: 10.1186/s43058-024-00588-7.
PubMed 38720363