Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
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|ClinicalTrials.gov Identifier: NCT03670316|
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|HIV AIDS Smoking Cessation||Drug: Algorithm Treatment Other: Quitline only||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to either the Algorithm Treatment plus referral to a quitline (AT) or the quitline alone condition (eTAU).|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care|
|Actual Study Start Date :||August 17, 2020|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
Experimental: Algorithm Treatment plus referral to quitline (AT)
will be assigned a pharmacotherapy treatment regimen recommended to their provider.
Drug: Algorithm Treatment
Varenicline was selected as the first line of treatment for patients willing to take a medication twice per day and wanting cessation. Following varenicline, bupropion and then NRT are subsequent options. In terms of preference for NRT, nicotine patches would be the first option followed by lozenge, gum, inhaler, and nasal spray. The order of NRT within the algorithm is based upon patient familiarity and number of clinical trials supporting their use. Combination NRT (e.g., patch and lozenge) or adding NRT to varenicline or bupropion is offered to participants who have made an unsuccessful quit attempt with these medications in the past. If none of these medications are appropriate, then the participant is offered counseling only.
Active Comparator: Quitline (eTAU)
will be referred to quitlines, telephone-based tobacco cessation services.
Other: Quitline only
eTAU participants will complete the same algorithm questions but will not have this information sent to their provider, although their provider may elect to prescribe medication as part of standard of care. Participants will be referred to a quitline for behavioral support services for cessation.
- 7-day point-prevalence abstinence [ Time Frame: 6 months ]Number of cigarettes smoked over the past 7 days
- Cigarettes per day [ Time Frame: 6 months ]Number of cigarettes reported being smoked per day
- 24 hour quit attempts [ Time Frame: 6 months ]Attempt to not smoke for 24 hours
- Number of prescriptions written [ Time Frame: 6 months ]The number of prescriptions written for a participant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670316
|Contact: Karen L Cropsey, Psy.D.||firstname.lastname@example.org|
|Contact: Keith Chichester, B.A.||email@example.com|
|United States, Alabama|
|University of Alabama, Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35209|
|Contact: Mariel Parman, MPH 205-996-6377 firstname.lastname@example.org|
|Principal Investigator: Karen Cropsey, Psy.D.|