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

NCT03082482 | Completed

• 1 other identifier: 7278
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking Cessation

Keywords

Smoking Cessation; HIV; AIDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Participant satisfaction with treatment using the Client Satisfaction Questionnaire

  3-Month Follow-Up

• Dropout rate

  3-Month Follow-Up

• Intervention delivery rate

  3-Month Follow-Up

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

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; Drug: nicotine patch; Behavioral: Counseling

Automated Treatment

EXPERIMENTAL

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; Drug: nicotine patch; Other: Smartphone-delivered automated treatment

Interventions

Self-help materials BEHAVIORAL

Self-help smoking cessation materials

Automated Treatment; Standard Treatment

nicotine patch 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.

Automated Treatment; Standard Treatment

Counseling BEHAVIORAL

Proactive phone counseling with a Certified Tobacco Treatment Counselor

Standard Treatment

Smartphone-delivered automated treatment OTHER

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

Automated Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• 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.

  PMID: 32779730 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Acquired Immunodeficiency Syndrome

Interventions

Tobacco Use Cessation Devices; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Damon Vidrine, DrPH

  OUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: May 15, 2017
• Primary Completion: May 19, 2017
• Study Completion: December 31, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)