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Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV (AVAST-HIV)

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ClinicalTrials.gov Identifier: NCT03082482
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief 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).

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Self-help materials Drug: nicotine patch Behavioral: Counseling Other: Smartphone-delivered automated treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV: Project AVAST - HIV
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : May 19, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Treatment
Participants randomized to Standard Treatment will receive a smartphone with active service, brief advice to quit smoking (self-help materials), and 8-week supply of nicotine replacement therapy (patches), and provided 5 proactive phone counseling sessions by a trained Certified Tobacco Treatment Specialist.
Behavioral: Self-help materials
Self-help smoking cessation materials

Drug: nicotine patch
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.

Behavioral: Counseling
Proactive phone counseling with a Certified Tobacco Treatment Counselor

Experimental: Automated Treatment
Participants randomized to Automated Treatment will receive smartphone-delivered automated treatment that will provide tailored smoking cessation treatment by way of video clips, text and graphical messages. Participants will receive notifications on the study provided smartphone once a week for an 8-week treatment period. Content delivered will be specific to the participants smoking status and motivation to quit.
Behavioral: Self-help materials
Self-help smoking cessation materials

Drug: nicotine patch
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.

Other: Smartphone-delivered automated treatment
Tailored video clips, text and graphical messages delivered automatically each week to the participant.




Primary Outcome Measures :
  1. Smoking status by collecting an expired carbon monoxide breath sample [ Time Frame: 3-Month Follow-Up ]
    Biochemically verifying smoking status on all participants by collecting an expired carbon monoxide breath sample.


Secondary Outcome Measures :
  1. Participant satisfaction with treatment using the Client Satisfaction Questionnaire [ Time Frame: 3-Month Follow-Up ]
    The investigators will use the Client Satisfaction Questionnaire to evaluate participant satisfaction.

  2. Dropout rate [ Time Frame: 3-Month Follow-Up ]
    The investigators will assess the number of participants who dropped out of the study.

  3. Intervention delivery rate [ Time Frame: 3-Month Follow-Up ]
    The investigators will assess the number of sessions completed by participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >/= 18 years
  • Smoked >/= 100 cigarettes in a lifetime
  • English speaking
  • Currently smoking 5 or more cigarettes per day
  • Willing to make a quit attempt within 1 week of enrollment
  • HIV positive

Exclusion Criteria:

  • History of medical condition that precludes the use of nicotine replacement therapy
  • Current use of smoking cessation medications
  • Pregnant or nursing
  • Enrolled in another smoking cessation study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082482


Locations
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United States, Oklahoma
Oklahoma Tobacco Research Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Damon Vidrine, DrPH OUHSC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03082482    
Other Study ID Numbers: 7278
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
Smoking Cessation
HIV
AIDS
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action