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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Storytelling Narrative Intervention
Sponsored by
University of Massachusetts, Boston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University Massachusetts Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quitting Smoking Video

HIV Infection Video

Arm Description

This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 15, 2017
Last Updated
August 2, 2019
Sponsor
University of Massachusetts, Boston
Collaborators
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03289676
Brief Title
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
Acronym
WISE
Official Title
Determining the Feasibility and Acceptability of a Combined Storytelling Narrative Communication and HIV-tailored Smoking Cessation Intervention for Women Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Boston
Collaborators
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
: The proposed study has two phases. 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. 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.
Masking
Outcomes Assessor
Masking Description
The person who assesses follow-up assessments will be blind to treatment condition.
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quitting Smoking Video
Arm Type
Experimental
Arm Description
This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.
Arm Title
HIV Infection Video
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Storytelling Narrative Intervention
Other Intervention Name(s)
Cognitive Behavioral Counseling, Nicotine Replacement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence Rate
Description
Women in both arms who reported having watched all four videos of the storytelling narrative intervention.
Time Frame
3 months
Title
3-month Abstinence Rate
Description
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
Secondary Outcome Measure Information:
Title
Self-efficacy in Resisting Smoking Temptation.
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Who are biologically females.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun S Kim
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Massachusetts Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34999667
Citation
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.
Results Reference
derived
PubMed Identifier
31977840
Citation
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.
Results Reference
derived
PubMed Identifier
31863582
Citation
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.
Results Reference
derived

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

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