- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03289676
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV (WISE)
Determining the Feasibility and Acceptability of a Combined Storytelling Narrative Communication and HIV-tailored Smoking Cessation Intervention for Women Living With HIV
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02125
- University Massachusetts Boston
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
women who:
- are able to speak English
- self-report HIV infection and submit a supplementary document if necessary
- are between the ages of 18 and 65
- have been smoking at least 5 cigarettes a day for the past 6 months
- own a mobile phone with an access to a video call application such as Skype, Imo, Tango, and Face Time
- are willing to quit smoking within the next 4 weeks from the baseline assessment; and
- 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:
- are not able to speak English
- are pregnant or lactating
- have an active skin disease or serious alcohol use problems (≥ 26 on the Alcohol Use Disorders Identification Test59)
- self-report currently receiving treatment for a serious mental illness (e.g., schizophrenia and bipolar disorder) or
- currently use any illegal substances excluding marijuana.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quitting Smoking Video
This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.
|
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.
Other Names:
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Active Comparator: HIV Infection Video
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence Rate
Time Frame: 3 months
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Women in both arms who reported having watched all four videos of the storytelling narrative intervention.
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3 months
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3-month Abstinence Rate
Time Frame: 3 months
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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.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy in Resisting Smoking Temptation.
Time Frame: 3 months
|
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.
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3 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sun S Kim, University of Massachusetts, Worcester
Publications and helpful links
General Publications
- Kim SS, DeMarco RF. The Intersectionality of HIV-Related Stigma and Tobacco Smoking Stigma With Depressive and Anxiety Symptoms Among Women Living With HIV in the United States: A Cross-sectional Study. J Assoc Nurses AIDS Care. 2022 Sep-Oct 01;33(5):523-533. doi: 10.1097/JNC.0000000000000323. Epub 2022 Jan 7.
- Kim SS, Cooley ME, Lee SA, DeMarco RF. Prediction of Smoking Abstinence in Women Living With Human Immunodeficiency Virus Infection. Nurs Res. 2020 May/Jun;69(3):167-175. doi: 10.1097/NNR.0000000000000421.
- Kim SS, Lee SA, Mejia J, Cooley ME, Demarco RF. Pilot Randomized Controlled Trial of a Digital Storytelling Intervention for Smoking Cessation in Women Living With HIV. Ann Behav Med. 2020 May 25;54(6):447-454. doi: 10.1093/abm/kaz062.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 2017147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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