Botswana Smoking and Abstinence Reinforcement Trial

NCT ID: NCT05694637

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2027-08-31

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.

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

Hiv; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SBIRT

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.

Group Type: ACTIVE_COMPARATOR

Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange)

Intervention Type: BEHAVIORAL

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.

Varenicline

Intervention Type: DRUG

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.

Standard of Care

Trained LHWs will provide a brief motivation counseling and a brochure about smoking cessation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange)

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.

Intervention Type: BEHAVIORAL

Varenicline

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Less than 18 years of age
• Pregnant
• Unable or cognitively impaired to provide consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore County

OTHER

Sponsor Role: collaborator

University of Maryland, College Park

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Man Charurat

Director, Division of Epidemiology and Prevention

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manhattan Charurat, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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

Countries

Botswana

References

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.

Reference Type: DERIVED

PMID: 38720363 (View on PubMed)

Other Identifiers

HP-00102995

Identifier Type: -

Identifier Source: org_study_id