Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • HIV Infections
  • Smoking
  • Smoking Cessation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: We will use permuted block randomization with random block sizes between 6 and 9 and stratified by sex and depressive symptoms. The blocks will ensure near 1:1 balance throughout the study. The random block sizes will protect against selection bias by preventing staff from predicting which intervention any one individual will be assigned. We will stratify by sex to ensure balance of women in both arms since smoking is more common in men. We will stratify by depressive symptoms to ensure balance in testing whether the effect of BAPS is differential between those with and without greater degrees of distress. While a Mood Module of PRIME-MD score of >5 symptoms is commonly used as a threshold for depression (Spitzer et al., 1994), we are also targeting lower level symptoms with this intervention having found that lower levels are associated with health behaviors such as medication adherence (Gross et al., 2017).Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Eligible patients will be randomized to one of the treatment arms, which will involve 5 phone-delivered counseling sessions over a 9-week treatment phase. While enrolled in this research study, you will also be asked not to use any smoking cessation treatment (including medication or behavioral ther...

Eligible patients will be randomized to one of the treatment arms, which will involve 5 phone-delivered counseling sessions over a 9-week treatment phase. While enrolled in this research study, you will also be asked not to use any smoking cessation treatment (including medication or behavioral therapy) other than that which is provided to you within the context of this clinical study. The session will either be run by a study coordinator or a counselor. The study coordinator gathers information about you so we can understand whether or not the program is working. The study coordinator will be the person conducting the assessments. The counselor works with you to help you stop smoking. Study visits are described in more detail below. Intake Complete the study informed consent with a research staff member. You will have the opportunity to have your questions answered before signing the study consent form. If you chose not to sign this form, no procedures will be performed Complete a breath carbon monoxide (CO) assessment to measure your smoke exposure. Carbon monoxide is a poisonous gas that comprises less than 1% of the air we breathe and is also produced through smoking a cigarette. Your CO levels provide an indication of how much cigarette smoke you have been exposed to. Complete paper and pencil assessments of your demographics, alcohol and smoking history, smoking and health behaviors, and mood. Weeks 1,3,5,7, and 9 Phone-delivered counseling session (SC or BAPS) that will last between 30-60 min to help prepare you for your upcoming quit attempt (Week 2, Target Quit Day) These sessions will focus on reinforcing your success and reviewing your quit plan or on reestablishing another quit date and restarting the smoking cessation process Weeks 10 and 26 Assessments only, the same ones administered during the intake session If you are quit (have not smoked in the past 7 days), you will be asked to come in to provide a CO breath sample

Tracking Information

NCT #
NCT04532970
Collaborators
  • National Institute on Drug Abuse (NIDA)
  • University of Botswana
Investigators
Not Provided
About Us
Innovation
Privacy
Terms
Copyright
Get Well Soon © Copyright 2024