Trial Outcomes & Findings for Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV (NCT NCT03289676)
NCT ID: NCT03289676
Last Updated: 2019-09-09
Results Overview
Women in both arms who reported having watched all four videos of the storytelling narrative intervention.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
53 participants
Primary outcome timeframe
3 months
Results posted on
2019-09-09
Participant Flow
Participant milestones
| Measure |
Quitting Smoking Film
This arm viewed a storytelling narrative film of six women living with HIV taking about their success in quitting smoking.
A total of 27 women were randomized into this arm and four women withdrew from the study right before receiving any of the allotted intervention.
Of the remaining 23 women, 18 women received at least 80% of the allotted intervention, and all 23 women completed the study without any more loss.
Outcome analysis was done separately with 27 women who were randomized into the arm and with 23 women who actually received any part of the allotted intervention.
|
HIV Infection (an Attnetion-control) Film
This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.
A total of 26 women were randomized into this arm and 20 women received at least 80% of the allotted intervention. One was lost during the follow-up period and 25 women completed the study.
Outcome analysis was done with 26 women who were randomized into the arm.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Quitting Smoking Film
This arm viewed a storytelling narrative film of six women living with HIV taking about their success in quitting smoking.
A total of 27 women were randomized into this arm and four women withdrew from the study right before receiving any of the allotted intervention.
Of the remaining 23 women, 18 women received at least 80% of the allotted intervention, and all 23 women completed the study without any more loss.
Outcome analysis was done separately with 27 women who were randomized into the arm and with 23 women who actually received any part of the allotted intervention.
|
HIV Infection (an Attnetion-control) Film
This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.
A total of 26 women were randomized into this arm and 20 women received at least 80% of the allotted intervention. One was lost during the follow-up period and 25 women completed the study.
Outcome analysis was done with 26 women who were randomized into the arm.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
Baseline characteristics by cohort
| Measure |
Quitting Smoking Video
n=27 Participants
This arm watched a film in which six women living with HIV talk about why they decided to quit smoking and how they did.
|
HIV Infection Video
n=26 Participants
This arm watched an attention-control film in which four women talk about their everyday lives before and after the diagnosis of HIV.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.81 Years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
50.92 Years
STANDARD_DEVIATION 6.76 • n=7 Participants
|
51.38 Years
STANDARD_DEVIATION 6.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence
|
6.19 units on a scale
STANDARD_DEVIATION 2.42 • n=5 Participants
|
4.73 units on a scale
STANDARD_DEVIATION 2.16 • n=7 Participants
|
5.47 units on a scale
STANDARD_DEVIATION 2.39 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsWomen in both arms who reported having watched all four videos of the storytelling narrative intervention.
Outcome measures
| Measure |
Quitting Smoking Video
n=23 Participants
This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.
|
HIV Infection Video
n=25 Participants
This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.
|
|---|---|---|
|
Adherence Rate
|
20 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 3 monthsParticipants in both arms who self-reported having not smoked a cigarette for 3 months from the quit day and also whose salivary cotinine test showed a negative result at 3-month follow-up.
Outcome measures
| Measure |
Quitting Smoking Video
n=27 Participants
This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.
|
HIV Infection Video
n=26 Participants
This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.
|
|---|---|---|
|
3-month Abstinence Rate
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThis scale assesses participants' confidence (self-efficacy) in resisting smoking temptation in nine specific situations. Each item score ranges from 1 (completely unconfident) to 5 (completely confident). The scale score is the sum of each item score and ranges from 9 to 45. Higher scores represent more confidence and better outcome.
Outcome measures
| Measure |
Quitting Smoking Video
n=23 Participants
This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.
|
HIV Infection Video
n=25 Participants
This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.
|
|---|---|---|
|
Self-efficacy in Resisting Smoking Temptation.
|
35.5 units on the scale
Standard Deviation 10.1
|
31.8 units on the scale
Standard Deviation 8.1
|
Adverse Events
Quitting Smoking Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Infection Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place