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

NCT ID: NCT03082482

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2017-12-31

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).

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Self-help materials

Intervention Type: BEHAVIORAL

Self-help smoking cessation materials

nicotine patch

Intervention Type: DRUG

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.

Counseling

Intervention Type: BEHAVIORAL

Proactive phone counseling with a Certified Tobacco Treatment Counselor

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.

Group Type: EXPERIMENTAL

Self-help materials

Intervention Type: BEHAVIORAL

Self-help smoking cessation materials

nicotine patch

Intervention Type: DRUG

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.

Smartphone-delivered automated treatment

Intervention Type: OTHER

Tailored video clips, text and graphical messages delivered automatically each week to the participant.

Interventions

Self-help materials

Self-help smoking cessation materials

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Counseling

Proactive phone counseling with a Certified Tobacco Treatment Counselor

Intervention Type: BEHAVIORAL

Smartphone-delivered automated treatment

Tailored video clips, text and graphical messages delivered automatically each week to the participant.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damon Vidrine, DrPH

Role: PRINCIPAL_INVESTIGATOR

OUHSC

Locations

Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, United States

Countries

United States

References

Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

Reference Type: DERIVED

PMID: 32779730 (View on PubMed)

Other Identifiers

7278

Identifier Type: -

Identifier Source: org_study_id