Trial Outcomes & Findings for Improving Adherence to Smoking Cessation Medication Among PLWHA (NCT NCT01898195)
NCT ID: NCT01898195
Last Updated: 2017-08-18
Results Overview
number of participants who took at least 80% prescribed dose since last interview, based on pill count
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
158 participants
Primary outcome timeframe
4 Weeks
Results posted on
2017-08-18
Participant Flow
Participant milestones
| Measure |
Standard Care
Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months.
|
Standard Care + Text Message
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
|
Standard Care + Text Message + ABT
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period
|
|---|---|---|---|
|
Varenicline Adherence
STARTED
|
53
|
54
|
51
|
|
Varenicline Adherence
COMPLETED
|
18
|
16
|
15
|
|
Varenicline Adherence
NOT COMPLETED
|
35
|
38
|
36
|
|
Smoking Abstinence
STARTED
|
53
|
54
|
51
|
|
Smoking Abstinence
COMPLETED
|
18
|
16
|
15
|
|
Smoking Abstinence
NOT COMPLETED
|
35
|
38
|
36
|
Reasons for withdrawal
| Measure |
Standard Care
Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months.
|
Standard Care + Text Message
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
|
Standard Care + Text Message + ABT
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period
|
|---|---|---|---|
|
Smoking Abstinence
Did not have good measurements
|
35
|
38
|
36
|
Baseline Characteristics
Improving Adherence to Smoking Cessation Medication Among PLWHA
Baseline characteristics by cohort
| Measure |
Standard Care
n=53 Participants
Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months.
|
Standard Care + Text Message
n=54 Participants
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
|
Standard Care + Text Message + ABT
n=51 Participants
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
46.64 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
46 years
STANDARD_DEVIATION 9.96 • n=7 Participants
|
47.88 years
STANDARD_DEVIATION 8.69 • n=5 Participants
|
46.84 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
54 participants
n=7 Participants
|
51 participants
n=5 Participants
|
158 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 Weeksnumber of participants who took at least 80% prescribed dose since last interview, based on pill count
Outcome measures
| Measure |
Standard Care
n=50 Participants
Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months.
|
Standard Care + Text Message
n=53 Participants
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
|
Standard Care + Text Message + ABT
n=50 Participants
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period
|
|---|---|---|---|
|
End-of-intervention Varenicline Adherence
|
18 participants
|
16 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 7 Daysnumber of participants who achieved smoking abstinence based on self-reported 7-day point prevalence smoking abstinence verified by a carbon monoxide (CO) \< 8 ppm
Outcome measures
| Measure |
Standard Care
n=53 Participants
Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months.
|
Standard Care + Text Message
n=54 Participants
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
|
Standard Care + Text Message + ABT
n=51 Participants
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period
|
|---|---|---|---|
|
End-of-intervention Smoking Abstinence
|
3 participants
|
2 participants
|
8 participants
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Standard Care + Text Message
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Care + Text Message + ABT
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Care
n=53 participants at risk
Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months.
|
Standard Care + Text Message
n=54 participants at risk
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
|
Standard Care + Text Message + ABT
n=51 participants at risk
Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period
|
|---|---|---|---|
|
General disorders
Nausea
|
1.9%
1/53 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/51
|
|
Psychiatric disorders
Agitation
|
0.00%
0/53
|
1.9%
1/54 • Number of events 1
|
0.00%
0/51
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/53 • Number of events 1
|
0.00%
0/54
|
2.0%
1/51 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
5.7%
3/53 • Number of events 3
|
0.00%
0/54
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Changes in appetite
|
3.8%
2/53 • Number of events 2
|
0.00%
0/54
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Vivd dreams or nightmares
|
3.8%
2/53 • Number of events 2
|
0.00%
0/54
|
5.9%
3/51 • Number of events 3
|
|
General disorders
Problem with sleeping
|
5.7%
3/53 • Number of events 3
|
0.00%
0/54
|
3.9%
2/51 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
0.00%
0/53
|
1.9%
1/54 • Number of events 1
|
0.00%
0/51
|
|
Skin and subcutaneous tissue disorders
Skin Peeling
|
0.00%
0/53
|
1.9%
1/54 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/53
|
0.00%
0/54
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • Number of events 1
|
0.00%
0/54
|
0.00%
0/51
|
|
General disorders
Dry Mouth
|
1.9%
1/53 • Number of events 1
|
0.00%
0/54
|
0.00%
0/51
|
|
General disorders
Leg Pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/54
|
0.00%
0/51
|
Additional Information
Donna Shelley, MD, MPH/ Vice Chair for Research; Associate Professor of Population Health and Medici
Department of Population Health, New York University School of Medicine
Phone: 646-501-2526
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place