Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05694637
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-08-01
First Post:
2022-12-07
Brief Title:
Botswana Smoking and Abstinence Reinforcement Trial
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Botswana Smoking and Abstinence Reinforcement Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BSMART
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 controlpre-implementation a 12-month implementation and a 12-month maintenance period The investigators will stratify Botswanas 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 ie have representation from 3 levels of facilities giving each level of facilities the same probability of beginning the intervention at any step
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None