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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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
July 25, 2023
Primary Completion Date
February 1, 2027
Completion Date
August 31, 2027
Last Updated
January 9, 2026
750
ESTIMATED participants
Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange)
BEHAVIORAL
Varenicline
DRUG
Lead Sponsor
University of Maryland, Baltimore
Collaborators
NCT01875588
NCT07071623
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04929028