Clinical trial NCT03082482: Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV
Official title: Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV: Project AVAST - HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking Cessation
HIV
AIDS
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Smoking status by collecting an expired carbon monoxide breath sample
timeFrame: 3-Month Follow-Up
Secondary outcomes:
measure: Participant satisfaction with treatment using the Client Satisfaction Questionnaire
timeFrame: 3-Month Follow-Up
measure: Dropout rate
timeFrame: 3-Month Follow-Up
measure: Intervention delivery rate
timeFrame: 3-Month Follow-Up
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Tobacco Research Center
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Damon Vidrine, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.