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Botswana Smoking and Abstinence Reinforcement Trial — BSMART  

Hiv Clinical Trial

Official title:
Botswana Smoking and Abstinence Reinforcement Trial

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05694637
Study type Interventional
Source University of Maryland, Baltimore
Contact
Status Enrolling by invitation
Phase Phase 4
Start date July 25, 2023
Completion date August 31, 2027
View Details
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