Botswana Smoking and Abstinence Reinforcement Trial (BSMART)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation; Hiv
• Intervention / Treatment: Behavioral: Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange); Drug: Varenicline

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).

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 4

Contacts and Locations

Study Locations

• Botswana
  • Central
    • Francistown, Central, Botswana
      • Itekeng Clinic
    • Francistown, Central, Botswana
      • Masego Clinic
    • Francistown, Central, Botswana
      • Nyangabgwe Referral Hospital
    • Sefhare, Central, Botswana
      • Sefhare Primary Hospital
    • Tutume, Central, Botswana
      • Tutume Primary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.; Drug: 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.
No Intervention: Standard of Care; Trained LHWs will provide a brief motivation counseling and a brochure about smoking cessation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 0, 1, 2, 4, 8, and 12

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: University of Kentucky; University of Maryland, College Park; University of Maryland, Baltimore County
• Investigators: Principal Investigator: Manhattan Charurat, PhD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: HP-00102995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No