Botswana Smoking and Abstinence Reinforcement Trial

Phase 4

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

• Registration Number: NCT05694637
• Lead Sponsor: University of Maryland, Baltimore

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).

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-23
• Study Start: 2023-07-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2027-02-01
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 750

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SBIRT	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.
SBIRT	Varenicline	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.

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence	Week 24	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

Secondary Outcome Measures

Name	Time	Method
Adherence to medication	Weeks 0, 1, 2, 4, 8, and 12	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.

Trial Locations

Locations (10)

Tutume Primary Hospital; 🇧🇼 Tutume, Central, Botswana

Masego Clinic; 🇧🇼 Francistown, Central, Botswana

Sefhare Primary Hospital; 🇧🇼 Sefhare, Central, Botswana

Airstrip Clinic; 🇧🇼 Mahalapye, Central, Botswana

Palpye Primary Hospital; 🇧🇼 Palapye, Central, Botswana

Thamaga Primary Hospital; 🇧🇼 Thamaga, Kweneng, Botswana

Nyangabgwe Referral Hospital; 🇧🇼 Francistown, Central, Botswana

Itekeng Clinic; 🇧🇼 Francistown, Central, Botswana

Morwa Clinic; 🇧🇼 Mochudi, Central, Botswana

Mahalapye District Hospital; 🇧🇼 Mahalapye, Central, Botswana