Trial Outcomes & Findings for A Smoking Cessation Trial in HIV-infected Patients in South Africa (NCT NCT01484340)
NCT ID: NCT01484340
Last Updated: 2019-10-04
Results Overview
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
560 participants
Primary outcome timeframe
6 months from baseline
Results posted on
2019-10-04
Participant Flow
Participant milestones
| Measure |
Counseling Only
Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).
Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
Nicotine Replacement Therapy +Counseling
Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).
Nicotine: The nicotine patch be given in three phases:
* 2 weeks of patches at enrollment
* 6 weeks of patches at two-week follow-up visit
* 2 weeks of patches at two-month follow-up visit
Intensive Counseling: same as in "Counseling only" arm
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
|---|---|---|
|
Overall Study
STARTED
|
281
|
279
|
|
Overall Study
COMPLETED
|
281
|
279
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Smoking Cessation Trial in HIV-infected Patients in South Africa
Baseline characteristics by cohort
| Measure |
Counseling Only
n=281 Participants
Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).
Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
Nicotine Replacement Therapy +Counseling
n=279 Participants
Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).
Nicotine: The nicotine patch be given in three phases:
* 2 weeks of patches at enrollment
* 6 weeks of patches at two-week follow-up visit
* 2 weeks of patches at two-month follow-up visit
Intensive Counseling: same as in "Counseling only" arm
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
Total
n=560 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
39 years
n=7 Participants
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
213 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African/Black
|
281 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
557 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Colored
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Indian/Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not documented
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
281 participants
n=5 Participants
|
279 participants
n=7 Participants
|
560 participants
n=5 Participants
|
|
Number of cigarettes smoked per day
|
10 cigarettes per day
n=5 Participants
|
9 cigarettes per day
n=7 Participants
|
10 cigarettes per day
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months from baselinePopulation: As treated analysis: Patients without biochemical verification at any visit were excluded from the denominator. Counseling only arm: 53 patients excluded. Nicotine Replacement Therapy +counseling arm: 54 patients excluded.
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.
Outcome measures
| Measure |
Counseling Only
n=228 Participants
Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).
Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
Nicotine Replacement Therapy +Counseling
n=225 Participants
Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).
Nicotine: The nicotine patch be given in three phases:
* 2 weeks of patches at enrollment
* 6 weeks of patches at two-week follow-up visit
* 2 weeks of patches at two-month follow-up visit
Intensive Counseling: same as in "Counseling only" arm
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
|---|---|---|
|
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
|
11 COppm
Interval 5.0 to 19.0
|
11 COppm
Interval 6.0 to 18.0
|
PRIMARY outcome
Timeframe: 6 months from baselinePopulation: As treated analysis: Patients without biochemical verification at any visit were excluded from the denominator. Counseling only arm: 53 patients excluded. Nicotine Replacement Therapy +counseling arm: 54 patients excluded.
A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A reading of \< 0.4 μg/ml cotinine equivalent will indicate abstinence.
Outcome measures
| Measure |
Counseling Only
n=228 Participants
Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).
Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
Nicotine Replacement Therapy +Counseling
n=225 Participants
Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).
Nicotine: The nicotine patch be given in three phases:
* 2 weeks of patches at enrollment
* 6 weeks of patches at two-week follow-up visit
* 2 weeks of patches at two-month follow-up visit
Intensive Counseling: same as in "Counseling only" arm
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
|---|---|---|
|
Smoking Status Using a Point of Care Test for Measuring Cotinine
|
1.7 μg/ml cotinine equivalent
Interval 0.5 to 4.7
|
1.5 μg/ml cotinine equivalent
Interval 0.3 to 5.3
|
SECONDARY outcome
Timeframe: 2 months from baselinePopulation: As treated analysis: Patients without biochemical verification at any visit were excluded from the denominator. Counseling only arm: 64 patients excluded. Nicotine Replacement Therapy +counseling arm: 60 patients excluded.
A point of care test for measuring CO will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.
Outcome measures
| Measure |
Counseling Only
n=217 Participants
Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).
Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
Nicotine Replacement Therapy +Counseling
n=219 Participants
Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).
Nicotine: The nicotine patch be given in three phases:
* 2 weeks of patches at enrollment
* 6 weeks of patches at two-week follow-up visit
* 2 weeks of patches at two-month follow-up visit
Intensive Counseling: same as in "Counseling only" arm
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
|---|---|---|
|
Smoking Status (COppm)
|
9 COppm
Interval 4.0 to 17.0
|
11 COppm
Interval 5.0 to 18.0
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: As treated analysis: Patients without biochemical verification at any visit were excluded from the denominator. Counseling only arm: 72 patients excluded. Nicotine Replacement Therapy +counseling arm: 74 patients excluded.
A point of care test for measuring CO will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.
Outcome measures
| Measure |
Counseling Only
n=209 Participants
Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).
Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
Nicotine Replacement Therapy +Counseling
n=205 Participants
Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).
Nicotine: The nicotine patch be given in three phases:
* 2 weeks of patches at enrollment
* 6 weeks of patches at two-week follow-up visit
* 2 weeks of patches at two-month follow-up visit
Intensive Counseling: same as in "Counseling only" arm
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
|---|---|---|
|
Smoking Status (COppm)
|
10 COppm
Interval 5.0 to 17.0
|
10 COppm
Interval 5.0 to 17.0
|
Adverse Events
Counseling Only
Serious events: 4 serious events
Other events: 0 other events
Deaths: 3 deaths
Nicotine Replacement Therapy +Counseling
Serious events: 5 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Counseling Only
n=281 participants at risk
Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).
Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
Nicotine Replacement Therapy +Counseling
n=279 participants at risk
Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).
Nicotine: The nicotine patch be given in three phases:
* 2 weeks of patches at enrollment
* 6 weeks of patches at two-week follow-up visit
* 2 weeks of patches at two-month follow-up visit
Intensive Counseling: same as in "Counseling only" arm
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
|
|---|---|---|
|
Renal and urinary disorders
Acute renal failure
|
0.36%
1/281 • Number of events 1
|
0.36%
1/279 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
0.36%
1/281 • Number of events 1
|
0.72%
2/279 • Number of events 2
|
|
General disorders
Hospitalization
|
0.36%
1/281 • Number of events 1
|
0.36%
1/279 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphoma
|
0.00%
0/281
|
0.36%
1/279 • Number of events 1
|
|
General disorders
Age with dehydration
|
0.36%
1/281 • Number of events 1
|
0.00%
0/279
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jonathan E. Golub
Johns Hopkins University School of Medicine
Phone: 443-287-2969
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place