Botswana Smoking and Abstinence Reinforcement Trial
BSMART
1 other identifier
interventional
750
1 country
15
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2023
Longer than P75 for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2022
CompletedFirst Posted
Study publicly available on registry
January 23, 2023
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
January 9, 2026
January 1, 2026
3.5 years
December 7, 2022
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Week 24
Secondary Outcomes (1)
Adherence to medication
Weeks 0, 1, 2, 4, 8, and 12
Study Arms (2)
SBIRT
ACTIVE COMPARATORTrained 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.
Standard of Care
NO INTERVENTIONTrained LHWs will provide a brief motivation counseling and a brochure about smoking cessation.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Less than 18 years of age
- Pregnant
- Unable or cognitively impaired to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- University of Maryland, Baltimore Countycollaborator
- University of Maryland, College Parkcollaborator
- University of Chicagocollaborator
Study Sites (15)
Itekeng Clinic
Francistown, Central District, Botswana
Masego Clinic
Francistown, Central District, Botswana
Nyangabgwe Referral Hospital
Francistown, Central District, Botswana
Airstrip Clinic
Mahalapye, Central District, Botswana
Mahalapye District Hospital
Mahalapye, Central District, Botswana
Morwa Clinic
Mochudi, Central District, Botswana
Palpye Primary Hospital
Palapye, Central District, Botswana
Sefhare Primary Hospital
Sefhare, Central District, Botswana
Tutume Primary Hospital
Tutume, Central District, Botswana
Thamaga Primary Hospital
Thamaga, Kweneng District, Botswana
Goodhope Primary Hospital
Good Hope, Botswana
Kanye Adventist Hospital
Kanye, Botswana
Kediretswe Clinic
Palapye, Botswana
Sekgoma District Hospital
Serowe, Botswana
Serowe Clinic
Serowe, Botswana
Related Publications (1)
Bada 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.
PMID: 38720363DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manhattan Charurat, PhD
University of Maryland, Baltimore
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Division of Epidemiology and Prevention
Study Record Dates
First Submitted
December 7, 2022
First Posted
January 23, 2023
Study Start
July 25, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share