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Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV

Determining the Feasibility and Acceptability of a Combined Storytelling Narrative Communication and HIV-tailored Smoking Cessation Intervention for Women Living With HIV

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03289676
Acronym
WISE
Enrollment
53
Registered
2017-09-21
Start date
2017-09-06
Completion date
2018-11-01
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Brief summary

HIV has transformed into a chronic illness due to the advent of effective treatments in the absence of a cure. As a result, the prevalence of non-AIDS defining cancers (NADCs), including lung cancer, has increased three-fold among people living with HIV. NADCs now account for 50% of all cancers among the people. Smoking is one of the major contributing factors to lung cancer and smoking prevalence is substantially higher in this population than the general U.S. population. Smoking prevalence does not differ by gender among people living with HIV. Women of color, particularly African American women represent the majority of women living with HIV (WLHIV) followed by Latinas. WLHIV smoke at a rate almost 3 times higher than that for the general U.S. female population (e.g., 42% vs. 16%). The proposed study has two phases: 1) the development of a storytelling narrative communication (SNC) intervention that will be added to an established HIV-tailored smoking cessation intervention and 2) a two-arm randomized controlled trial (RCT) of the HIV-tailored intervention plus the SNC Intervention compared with the HIV-tailored intervention only. The investigators will develop narrative videos with three to five WLHIV who will be talking about their personal struggles with smoking and success in quitting. Preliminary study revealed that the established HIV-tailored intervention was effective only for short-term (≤ 2 months) abstinence. Many relapsed to smoking between the 2nd and 6th month of quitting. The investigators propose that the SNC intervention will be an effective strategy to sustain their quit efforts for long-term abstinence (≥ 6 months). A total of 60 WLHIV will be recruited and randomly assigned to either the experimental arm (a combination of HIV-tailored and SNC interventions) or the control arm (HIV-tailored intervention only). Specific aims of the study are to 1) Identify SNC intervention components that are rated high in transport and identification for use as an enhancement to an HIV-tailored smoking cessation intervention; 2) Determine the feasibility and acceptability of the SNC intervention for WLHIV by assessing the rate of recruitment and retention for feasibility and the degree of transport and identification for acceptability; and 3) Establish an effect size of HIV-tailored and SNC interventions for smoking cessation in comparison with the HIV-tailored smoking cessation intervention only for WLHIV, for subsequent grant applications.

Detailed description

The proposed study employs a mixed-methods research design. The investigators will first develop narrative videos in collaboration with community organizations of WLHIV in Boston. Second, the investigators will conduct a two-arm RCT assigning participants at a ratio of 1:1 to either one of the two arms (Experimental: HIV-tailored plus SNC interventions vs. Control: HIV-tailored intervention). Both arms have eight weekly sessions of a 30-minute HIV-tailored cessation intervention (cognitive behavioral therapy plus nicotine patches). The experimental arm will receive three 5-7 minute SNC videos, each per month between the first and third month of quitting, whereas the control arm will receive three 5-minute attention control videos at the same monthly interval. A total of 60 WLHIV will be recruited via online and offline advertisements and personal networks of community organizations and health care providers who work for people with HIV. To participate in the study, the following criteria must be met: women who 1) are able to speak English; 2) self-report HIV infection and submit a supplementary document if necessary; 3) are between the ages of 18 and 65; 4) have been smoking at least 5 cigarettes a day for the past 6 months; 5) own a mobile phone with an access to a video call application such as Skype, Imo, Tango, and Face Time; 6) are willing to quit smoking within the next 4 weeks from the baseline assessment; and 7) agree to use an approved form of birth control (e.g., oral medications, condoms, and intrauterine devices) during the study period. Individuals will be excluded if they: 1) are not able to speak English; 2) are pregnant or lactating; 3) have an active skin disease or serious alcohol use problems (≥ 26 on the Alcohol Use Disorders Identification Test), 4) self-report currently receiving treatment for a serious mental illness (e.g., schizophrenia and bipolar disorder); or 5) currently use any illegal substances excluding marijuana. The investigators will recruit participants with frequent announcements of the study in Craigslist and paid online advertisements. The majority of intake interviews will be conducted via telephone, which will take 30 minutes at most. To prevent attrition, the investigators will execute several strategies, including tracking subjects at least every other month and providing incentives for follow-up testing. Counselors will proactively call participants prior to each therapy session and confirm the appointment a few hours before the session. A research assistant (RA) who will be blinded to the intervention condition will conduct all follow-up assessments via telephone calls and videoconferencing for saliva cotinine tests.

Interventions

COMBINATION_PRODUCTStorytelling 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.

Sponsors

Dana-Farber Cancer Institute
CollaboratorOTHER
University of Massachusetts, Boston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The person who assesses follow-up assessments will be blind to treatment condition.

Intervention model description

: The proposed study has two phases. 1. Phase 1. Development of Narrative Video: We will first develop narrative videos in collaboration with community organizations of WLHIV in Boston. The video will be filmed in person at the University of Massachusetts Boston. 2. Phase 2. A Randomized Controlled Trial (RCT) of a Story Telling Narrative Communication Intervention: We will conduct a two-arm RCT assigning participants at a ratio of 1:1 to either one of the two arms (Experimental: HIV-tailored plus SNC interventions vs. Control: HIV-tailored plus attention-control interventions). Both arms will have eight weekly sessions of a 30-minute HIV-tailored cessation intervention (cognitive behavioral therapy plus nicotine patches). All research-related procedures will be conducted remotely.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

women who: 1. are able to speak English 2. self-report HIV infection and submit a supplementary document if necessary 3. are between the ages of 18 and 65 4. have been smoking at least 5 cigarettes a day for the past 6 months 5. own a mobile phone with an access to a video call application such as Skype, Imo, Tango, and Face Time 6. are willing to quit smoking within the next 4 weeks from the baseline assessment; and 7. agree to use an approved form of birth control (e.g., oral medications, condoms, and intrauterine devices) during the study period.

Exclusion criteria

Women who: 1. are not able to speak English 2. are pregnant or lactating 3. have an active skin disease or serious alcohol use problems (≥ 26 on the Alcohol Use Disorders Identification Test59) 4. self-report currently receiving treatment for a serious mental illness (e.g., schizophrenia and bipolar disorder) or 5. currently use any illegal substances excluding marijuana.

Design outcomes

Primary

MeasureTime frameDescription
Adherence Rate3 monthsWomen in both arms who reported having watched all four videos of the storytelling narrative intervention.
3-month Abstinence Rate3 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.

Secondary

MeasureTime frameDescription
Self-efficacy in Resisting Smoking Temptation.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Quitting Smoking Video
This arm watched a film in which six women living with HIV talk about why they decided to quit smoking and how they did.
27
HIV Infection Video
This arm watched an attention-control film in which four women talk about their everyday lives before and after the diagnosis of HIV.
26
Total53

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up01
Overall StudyProtocol Violation20
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicQuitting Smoking VideoHIV Infection VideoTotal
Age, Continuous51.81 Years
STANDARD_DEVIATION 7.02
50.92 Years
STANDARD_DEVIATION 6.76
51.38 Years
STANDARD_DEVIATION 6.84
Fagerstrom Test for Nicotine Dependence6.19 units on a scale
STANDARD_DEVIATION 2.42
4.73 units on a scale
STANDARD_DEVIATION 2.16
5.47 units on a scale
STANDARD_DEVIATION 2.39
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
22 Participants24 Participants46 Participants
Race (NIH/OMB)
More than one race
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
1 Participants2 Participants3 Participants
Sex: Female, Male
Female
27 Participants26 Participants53 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 26
other
Total, other adverse events
0 / 270 / 26
serious
Total, serious adverse events
0 / 270 / 26

Outcome results

Primary

3-month Abstinence Rate

Participants 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.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quitting Smoking Video3-month Abstinence Rate10 Participants
HIV Infection Video3-month Abstinence Rate4 Participants
Primary

Adherence Rate

Women in both arms who reported having watched all four videos of the storytelling narrative intervention.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quitting Smoking VideoAdherence Rate20 Participants
HIV Infection VideoAdherence Rate17 Participants
p-value: 0.29Fisher Exact
Secondary

Self-efficacy in Resisting Smoking Temptation.

This 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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Quitting Smoking VideoSelf-efficacy in Resisting Smoking Temptation.35.5 units on the scaleStandard Deviation 10.1
HIV Infection VideoSelf-efficacy in Resisting Smoking Temptation.31.8 units on the scaleStandard Deviation 8.1
p-value: 0.02995% CI: [1, 1.24]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026