Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03342027
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2017-11-09
Brief Title:
Smoking Cessation Interventions for People Living With HIV in Nairobi Kenya
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Optimizing Smoking Cessation Interventions for People Living With HIV in Nairobi Kenya
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
Brief Summary:
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke The study will randomize 300 participants people living with HIV who smoke and who are receiving care in HIV clinics affiliated with the Center for International Health Education and Biosecurity in Nairobi Kenya to one of the following 4 conditions 1 bupropion Positively Smoke Free an 8 session tailored behavioral intervention for people living with HIV smokers 2 bupropion Standard of Care brief advice to quit 3 Placebo Positively Smoke Free and 4 Placebo Standard of Care
Detailed Description:
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke The will randomize 300 participants people living with HIV who smoke and who are receiving care at HIV clinics affiliated with the Center for International Health Education and Biosecurity in Nairobi Kenya to one of the following 4 conditions 1 bupropion Positively Smoke Free an 8 session tailored behavioral intervention for people living with HIV smokers 2 bupropion Standard of Care brief advice to quit 3 Placebo Positively Smoke Free and 4 Placebo Standard of Care The study will use a factorial design as it is a highly efficient method of assessing multiple treatments in a single trial with the possibility of saving both time and resources All participants will be assessed at baseline12 weeks and 36 weeks with the main outcome being 7-day abstinence defined as self-reported no smoking in the past 7 days CO7 ppm
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?:
False
Is an FDA AA801 Violation?:
None