HIV/AIDSPhase 1WISENCT03289676
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
A Phase 1 study testing Storytelling Narrative Intervention in people with HIV/AIDS, run by University of Massachusetts, Boston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Storytelling Narrative Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 1 Nov 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Massachusetts Boston
Boston, Massachusetts, 02125
About this study
Official title: Determining the Feasibility and Acceptability of a Combined Storytelling Narrative Communication and HIV-tailored Smoking Cessation Intervention for Women Living With HIV
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Storytelling Narrative Intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling Narrative InterventionCombination product
Also called Cognitive Behavioral Counseling, Nicotine Replacement Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Quitting Smoking Video | Experimental | This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking. Receives: Combination Product: Storytelling Narrative Intervention |
| HIV Infection Video | Active comparator | 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. Receives: Combination Product: Storytelling Narrative Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rate
Women in both arms who reported having watched all four videos of the storytelling narrative intervention.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start6 Sep 2017
- Primary completion23 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Sun S Kim, University of Massachusetts, Boston
- Investigators
- Sun S Kim, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289676
- Sponsor's protocol ID
- 2017147
- Acronym
- WISE
- Status last verified
- Aug 2019
- First submitted
- 15 Sep 2017
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34999667Kim 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.
PubMed 31977840Kim 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.
PubMed 31863582
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility and Acceptability of a Combined Storytelling Narrative Communication and HIV-tailored Smoking Cessation Intervention for Women Living With HIV
- ClinicalTrials.gov ID
- NCT03289676
- Acronym / sponsor ID
- WISE / 2017147
- Conditions
- HIV/AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Quitting Smoking Video | Experimental | Combination Product: Storytelling Narrative InterventionThis arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking. |
| HIV Infection Video | Active comparator | Combination Product: Storytelling Narrative InterventionThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Storytelling Narrative InterventionAlso: Cognitive Behavioral Counseling, Nicotine Replacement TherapyIn 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. | Combination product | HIV Infection Video, Quitting Smoking Video |
Primary outcome
Adherence Rate
Time frame: 3 months
Women in both arms who reported having watched all four videos of the storytelling narrative intervention.
3-month Abstinence Rate
Time frame: 3 months
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.
1 secondary outcome
Self-efficacy in Resisting Smoking Temptation.
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34999667Kim 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.
- Derived from this study: PubMed 31977840Kim 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.
- Derived from this study: PubMed 31863582Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun S Kim principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Storytelling Narrative Intervention in people with HIV/AIDS, run by University of Massachusetts, Boston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03289676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.