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

Smoking Cessation Clinical Trial

— AVAST-HIV  

Official title:

Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV: Project AVAST - HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082482
• Other study ID #: 7278
• Status: Completed
• Phase: N/A
• First received: March 13, 2017
• Last updated: April 10, 2018
• Start date: May 15, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

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

Locations

Country	Name	City	State
United States	Oklahoma Tobacco Research Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking status by collecting an expired carbon monoxide breath sample	Biochemically verifying smoking status on all participants by collecting an expired carbon monoxide breath sample.	3-Month Follow-Up
Secondary	Participant satisfaction with treatment using the Client Satisfaction Questionnaire	The investigators will use the Client Satisfaction Questionnaire to evaluate participant satisfaction.	3-Month Follow-Up
Secondary	Dropout rate	The investigators will assess the number of participants who dropped out of the study.	3-Month Follow-Up
Secondary	Intervention delivery rate	The investigators will assess the number of sessions completed by participants.	3-Month Follow-Up