Trial Outcomes & Findings for Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care (NCT NCT03670316)
NCT ID: NCT03670316
Last Updated: 2026-05-22
Results Overview
Self-report of cigarette smoking in the last 7 days
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
371 participants
Primary outcome timeframe
6 months
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
Algorithm Treatment (AT)
Algorithm Treatment: The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits.
|
Enhanced Treatment as Usual (eTAU)
Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line.
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
186
|
|
Overall Study
Withdrawn
|
1
|
0
|
|
Overall Study
COMPLETED
|
134
|
131
|
|
Overall Study
NOT COMPLETED
|
51
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
Baseline characteristics by cohort
| Measure |
Algorithm Treatment (AT)
n=184 Participants
Algorithm Treatment: The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits.
|
Enhanced Treatment as Usual (eTAU)
n=186 Participants
Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line.
|
Total
n=370 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 10.46 • n=2 Participants
|
49.0 years
STANDARD_DEVIATION 11.83 • n=4 Participants
|
49.2 years
STANDARD_DEVIATION 11.16 • n=6 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=2 Participants
|
28 Participants
n=4 Participants
|
63 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=2 Participants
|
158 Participants
n=4 Participants
|
307 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
98 Participants
n=2 Participants
|
92 Participants
n=4 Participants
|
190 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=2 Participants
|
83 Participants
n=4 Participants
|
157 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=2 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=2 Participants
|
172 Participants
n=4 Participants
|
340 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=2 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 118 missing
Self-report of cigarette smoking in the last 7 days
Outcome measures
| Measure |
Algorithm Treatment (AT)
n=126 Participants
Algorithm Treatment: The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits.
|
Enhanced Treatment as Usual (eTAU)
n=126 Participants
Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line.
|
|---|---|---|
|
7-day Point-prevalence Abstinence
No
|
16 Participants
Interval 5.0 to 20.0
|
12 Participants
Interval 5.0 to 16.2
|
|
7-day Point-prevalence Abstinence
Yes
|
110 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of cigarettes reported being smoked per day
Outcome measures
| Measure |
Algorithm Treatment (AT)
n=129 Participants
Algorithm Treatment: The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits.
|
Enhanced Treatment as Usual (eTAU)
n=132 Participants
Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line.
|
|---|---|---|
|
Cigarettes Per Day
|
9 Cigarettes per day
Interval 5.0 to 20.0
|
10 Cigarettes per day
Interval 5.0 to 16.5
|
SECONDARY outcome
Timeframe: 6 monthsAttempt to not smoke for 24 hours
Outcome measures
| Measure |
Algorithm Treatment (AT)
n=129 Participants
Algorithm Treatment: The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits.
|
Enhanced Treatment as Usual (eTAU)
n=133 Participants
Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line.
|
|---|---|---|
|
Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months
Yes
|
61 participants
|
72 participants
|
|
Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months
No
|
68 participants
|
61 participants
|
SECONDARY outcome
Timeframe: 6 monthsThe count of participants who had a smoking cessation prescription written
Outcome measures
| Measure |
Algorithm Treatment (AT)
n=185 Participants
Algorithm Treatment: The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits.
|
Enhanced Treatment as Usual (eTAU)
n=184 Participants
Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line.
|
|---|---|---|
|
Number of Prescriptions Written by 6-months
|
109 Participants
|
33 Participants
|
Adverse Events
Enhanced Treatment as Usual (eTAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Algorithm Treatment (AT)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enhanced Treatment as Usual (eTAU)
n=186 participants at risk
Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line.
|
Algorithm Treatment (AT)
n=184 participants at risk
The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal distress
|
0.00%
0/186 • Adverse event data were collected from the time a participant provided informed consent and was randomized in the study through ~ 10 months post-randomization.
We collected systematic information on serious adverse events via a study collection form.
|
1.1%
2/184 • Number of events 2 • Adverse event data were collected from the time a participant provided informed consent and was randomized in the study through ~ 10 months post-randomization.
We collected systematic information on serious adverse events via a study collection form.
|
|
General disorders
Unspecified side effects of medication
|
0.00%
0/186 • Adverse event data were collected from the time a participant provided informed consent and was randomized in the study through ~ 10 months post-randomization.
We collected systematic information on serious adverse events via a study collection form.
|
1.6%
3/184 • Number of events 3 • Adverse event data were collected from the time a participant provided informed consent and was randomized in the study through ~ 10 months post-randomization.
We collected systematic information on serious adverse events via a study collection form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place