Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The proposed pilot study seeks to address the smoking treatment needs of people living with
      HIV/AIDS (PLWHA) by evaluating the feasibility and preliminary efficacy of a smartphone
      delivered automated video-assisted smoking treatment (AVAST). AVAST will enable smoking
      cessation treatment content to be presented with voice/audio, images, videos, and text in an
      interactive, structured format anytime and anywhere. This automated treatment approach is
      designed to enhance treatment engagement and facilitate abstinence from smoking among PLWHA.
      Participants will be recruited from the University of Oklahoma Health Sciences Center (OUHSC)
      clinics providing care to HIV+ individuals (e.g., the Infectious Diseases Institute).
    

Detailed description: 
      Substantial evidence indicates that the prevalence of cigarette smoking among persons living
      with HIV/AIDS (PLWHA) is far higher than the prevalence in the general US population.
      Moreover, strong associations between smoking and numerous adverse AIDS- and non-AIDS-related
      outcomes have been detailed. Thus, efficacious smoking cessation programs targeted to PLWHA
      are needed. Despite the need, relatively few smoking cessation intervention trials for PLWHA
      have been conducted, and the published results from these trials have not been overly
      positive. The currently available literature indicates that HIV+ smokers appear to be
      motivated to quit, as evidenced by high enrollment rates. Also, it appears that more
      intensive interventions result in significantly higher quit rates (vs. minimal interventions)
      at short term and intermediate follow-ups. However, smoking relapse rates are very high, and
      treatment effects are not well sustained. This study seeks to address this treatment need by
      evaluating the feasibility and preliminary efficacy of a smartphone-delivered automated
      video-assisted smoking treatment (AVAST).

      Participants (n=20) will be randomized to one of two treatment conditions: 1) Standard
      Treatment (ST; n=10) or Automated Treatment (AT; n=10). In the ST condition, research staff
      will provide participants with in- person brief advice to quit and enroll them in a proactive
      telephone counseling program for smoking cessation. This ST approach mirrors the Ask Advise
      Connect (AAC) approach that our team has previously developed and implemented in numerous
      clinic settings. ST will be evaluated against AT, the fully automated AVAST approach. In the
      AT condition, smokers will be provided with in-person brief advice to quit and be enrolled in
      a fully automated and interactive smartphone-based treatment program that comprises
      interactive text messaging, images and audio/video clips. Participants in both treatment
      conditions will be provided with nicotine replacement therapy (NRT) in the form of
      transdermal patches. The goal of this pilot project is to establish the preliminary efficacy
      and feasibility of AT. Data collected in the pilot will then be used to support the
      submission of a NIH R01 application, and to determine if AT performs no worse than the more
      resource intensive ST approach. If lack of inferiority is established in the larger project,
      the AT approach will be readily scalable; easily implemented by community-based clinics and
      organizations; and offer an efficient way to allocate limited public health resources to
      tobacco control interventions.
    

Intervention name(s): Self-help materials; nicotine patch; Counseling; Smartphone-delivered automated treatment
Intervention type(s): Behavioral; Drug; Behavioral; Other
Intervention description(s): Self-help smoking cessation materials; Participants who smoke >10 cigarettes per day will receive 4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches. Participants who smoke <10 cigarettes per day will receive 6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches.; Proactive phone counseling with a Certified Tobacco Treatment Counselor; Tailored video clips, text and graphical messages delivered automatically each week to the participant.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; HIV; AIDS