Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Storytelling Narrative Intervention
Intervention type(s): Combination Product
Intervention description(s): 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 intervention name(s): Cognitive Behavioral Counseling; Nicotine Replacement Therapy
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Primary purpose: Treatment