Trial Outcomes & Findings for Smoking Cessation Intervention for Women Living With HIV (NCT NCT02898597)

NCT ID: NCT02898597

Last Updated: 2019-08-05

Results Overview

Self-reported abstinence since the quit day, which will be verified with a salivary cotinine test at both 3-month and 6-month follow-ups

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: 6-month follow-up
• Results posted on: 2019-08-05

Participant Flow

Participant milestones

Measure	Video Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling	Telephone Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling
Overall Study STARTED	25	24
Overall Study COMPLETED	21	12
Overall Study NOT COMPLETED	4	12

Reasons for withdrawal

Measure	Video Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling	Telephone Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling
Overall Study Protocol Violation	4	2
Overall Study Lost to Follow-up	0	9
Overall Study Death	0	1

Baseline Characteristics

Smoking Cessation Intervention for Women Living With HIV

Baseline characteristics by cohort

Measure	Video n=25 Participants This is the group that received the cognitive behavioral therapy for smoking cessation via video calls.	Voice n=24 Participants This is the group that received the cognitive behavioral therapy for smoking cessation via voice calls.	Total n=49 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
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	48.76 Years STANDARD_DEVIATION 9.05 • n=5 Participants	53.25 Years STANDARD_DEVIATION 6.49 • n=7 Participants	50.96 Years STANDARD_DEVIATION 8.14 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Nicotine Dependence	5.88 units on a scale STANDARD_DEVIATION 2.21 • n=5 Participants	5.16 units on a scale STANDARD_DEVIATION 1.86 • n=7 Participants	5.51 units on a scale STANDARD_DEVIATION 2.05 • n=5 Participants

PRIMARY outcome

Timeframe: 6-month follow-up

Population: Women living with HIV

Self-reported abstinence since the quit day, which will be verified with a salivary cotinine test at both 3-month and 6-month follow-ups

Outcome measures

Measure	Video n=21 Participants Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling	Telephone n=21 Participants Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling
Number of Participants With Abstinence	8 Participants	1 Participants

Adverse Events

Video

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telephone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Video n=25 participants at risk Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling	Telephone n=24 participants at risk Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling
Renal and urinary disorders Kidney failure	0.00% 0/25 • 6 months	4.2% 1/24 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sun Kim

University of Massachusetts Boston

Phone: 617-287-6831

Email: sun.kim@umb.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place