Smoking CessationAVAST-HIVNCT03082482
Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV
A study testing Self-help materials, nicotine patch and Counseling in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Self-help materials, nicotine patch and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >/= 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Tobacco Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV: Project AVAST - HIV
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).
Read the 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
- Being tested
- Self-help materials, nicotine patch, Counseling, Smartphone-delivered automated treatment
- Keywords
- Smoking Cessation, HIV, AIDS
- Medical subject headings
- Smoking Cessation, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help materialsBehavioural
Self-help smoking cessation materials
nicotine patchDrug
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.
CounselingBehavioural
Proactive phone counseling with a Certified Tobacco Treatment Counselor
Smartphone-delivered automated treatmentOther
Tailored video clips, text and graphical messages delivered automatically each week to the participant.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-help materials; Drug: nicotine patch; Other: Smartphone-delivered automated treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-Month Follow-Up
Secondary outcomes (3)
Participant satisfaction with treatment using the Client Satisfaction Questionnaire
The investigators will use the Client Satisfaction Questionnaire to evaluate participant satisfaction.
Measured: 3-Month Follow-Up
Dropout rate
The investigators will assess the number of participants who dropped out of the study.
Measured: 3-Month Follow-Up
Intervention delivery rate
The investigators will assess the number of sessions completed by participants.
Measured: 3-Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start15 May 2017
- Primary completion19 May 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damon Vidrine, DrPH, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082482
- Sponsor's protocol ID
- 7278
- Acronym
- AVAST-HIV
- Status last verified
- Apr 2018
- First submitted
- 13 Mar 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32779730
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-delivered Automated Video-assisted Smoking Treatment for People Living With HIV: Project AVAST - HIV
- ClinicalTrials.gov ID
- NCT03082482
- Acronym / sponsor ID
- AVAST-HIV / 7278
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, HIV, AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Behavioral: Self-help materials, Drug: nicotine patch, Behavioral: CounselingParticipants 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. |
| Automated Treatment | Experimental | Behavioral: Self-help materials, Drug: nicotine patch, Other: Smartphone-delivered automated treatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >/= 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help materialsSelf-help smoking cessation materials | Behavioural | Automated Treatment, Standard Treatment |
| nicotine patchParticipants 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. | Drug | Automated Treatment, Standard Treatment |
| CounselingProactive phone counseling with a Certified Tobacco Treatment Counselor | Behavioural | Standard Treatment |
| Smartphone-delivered automated treatmentTailored video clips, text and graphical messages delivered automatically each week to the participant. | Other | Automated Treatment |
Primary outcome
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.
3 secondary outcomes
Participant satisfaction with treatment using the Client Satisfaction Questionnaire
Time frame: 3-Month Follow-Up
Dropout rate
Time frame: 3-Month Follow-Up
Intervention delivery rate
Time frame: 3-Month Follow-Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Derived from this study: PubMed 32779730Palmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damon Vidrine, DrPH principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help materials, nicotine patch and Counseling in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking status by collecting an expired carbon monoxide breath sample (time frame: 3-Month Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.