HIV Infections, Smoking, Smoking Cessation
Conditions
Keywords
Mindfulness Training, Contingency Management
Brief summary
The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.
Interventions
DRUGNicotine Replacement Therapy
6 weeks of Nicotine replacement patches
BEHAVIORALMindfulness Training Smoking Cessation Intervention
Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.
BEHAVIORALContingency Management Smoking Cessation Intervention
Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with HIV (based on self-report). * Be 18 years and older * Have smoked ≥ 5 cigarettes/day in the past year * Be interested in making a quit attempt in the next 30 days * Own a smartphone (apple/android), and plan to keep it active for the next 6 months * Able to consent * Have no plans to move in the next 6 months * Are not pregnant or planning to be pregnant in the following 6 months * Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
Exclusion criteria
* Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder) * Are currently being treated for a psychiatric condition. * Are currently being treated for smoking cessation, alcoholism, or illicit drug use * Are adults unable to consent * Are individuals who are not yet adults * Are pregnant women * Are prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting 7-day Point-prevalence Abstinence | 4 weeks (end of treatment), and 3 months | Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level cutoff of \< 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 3 months | Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled. |
| Treatment Specific Adherence Rates | 3 months | Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management). |
Countries
United States
Participant flow
Pre-assignment details
Phase 2 participants are participants that did not quit smoking in their respective Phase 1 group, who were then assigned to the opposite group in Phase 2. Phase 1 MT participants who did not quit smoking go to Phase 2 CM, Phase 1 CM participants who did not quit smoking go to Phase 2 MT. Those participants who quit smoking do not get randomized again.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Training (MT) and NRT (Phase 1) Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions. | 49 |
| Contingency Management (CM) and NRT (Phase 1) Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Contingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom. | 46 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Phase 1 Participants | Did not attend sessions after being randomized | 16 | 9 | 0 | 0 |
| Phase 1 Participants | Lost to Follow-up | 12 | 22 | 0 | 0 |
| Phase 2 Participants | Lost to Follow-up | 0 | 0 | 6 | 2 |
Baseline characteristics
| Characteristic | Mindfulness Training (MT) and NRT (Phase 1) | Contingency Management (CM) and NRT (Phase 1) | Total |
|---|---|---|---|
| Age, Continuous | 54.54 years STANDARD_DEVIATION 8.49 | 51.59 years STANDARD_DEVIATION 11.63 | 53.07 years STANDARD_DEVIATION 10.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 36 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/ Asian American / Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 35 Participants | 33 Participants | 68 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 25 Participants | 21 Participants | 46 Participants |
| Sex: Female, Male Male | 24 Participants | 25 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 46 | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 49 | 0 / 46 | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 49 | 0 / 46 | 0 / 12 | 0 / 10 |
Outcome results
Primary
Number of Participants Reporting 7-day Point-prevalence Abstinence
Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level cutoff of \< 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL.
Time frame: 4 weeks (end of treatment), and 3 months
Population: Only those who participated in their treatment (completed at least one session).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mindfulness Training (MT) and NRT (Phase 1) | Number of Participants Reporting 7-day Point-prevalence Abstinence | 4 weeks (end of treatment) | 8 participants |
| Mindfulness Training (MT) and NRT (Phase 1) | Number of Participants Reporting 7-day Point-prevalence Abstinence | 3 months | 12 participants |
| Contingency Management (CM) and NRT (Phase 1) | Number of Participants Reporting 7-day Point-prevalence Abstinence | 3 months | 9 participants |
| Contingency Management (CM) and NRT (Phase 1) | Number of Participants Reporting 7-day Point-prevalence Abstinence | 4 weeks (end of treatment) | 12 participants |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Number of Participants Reporting 7-day Point-prevalence Abstinence | 4 weeks (end of treatment) | 3 participants |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Number of Participants Reporting 7-day Point-prevalence Abstinence | 3 months | 1 participants |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Number of Participants Reporting 7-day Point-prevalence Abstinence | 4 weeks (end of treatment) | 2 participants |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Number of Participants Reporting 7-day Point-prevalence Abstinence | 3 months | 2 participants |
Secondary
Retention Rate
Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.
Time frame: 3 months
Population: All participants who enrolled and were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness Training (MT) and NRT (Phase 1) | Retention Rate | 42.83 percentage of patients |
| Contingency Management (CM) and NRT (Phase 1) | Retention Rate | 32.61 percentage of patients |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Retention Rate | 50.00 percentage of patients |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Retention Rate | 80.00 percentage of patients |
Secondary
Treatment Specific Adherence Rates
Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).
Time frame: 3 months
Population: Includes all participants who were randomized to a treatment arm. Note that Phase 1 and Phase 2 participants are not mutually exclusive (Phase 2 participants come from Phase 1). Mindfulness Training participants did one call per week of treatment, 4 calls in total. Contingency management did 3 calls per week of treatment for a total of 12 calls.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mindfulness Training (MT) and NRT (Phase 1) | Treatment Specific Adherence Rates | Half of the check-ins | 2 participants |
| Mindfulness Training (MT) and NRT (Phase 1) | Treatment Specific Adherence Rates | More than half the check-ins but did not complete all | 9 participants |
| Mindfulness Training (MT) and NRT (Phase 1) | Treatment Specific Adherence Rates | 0 check-ins | 18 participants |
| Mindfulness Training (MT) and NRT (Phase 1) | Treatment Specific Adherence Rates | Less than half the check-ins | 4 participants |
| Mindfulness Training (MT) and NRT (Phase 1) | Treatment Specific Adherence Rates | Completed all check-ins | 16 participants |
| Contingency Management (CM) and NRT (Phase 1) | Treatment Specific Adherence Rates | Half of the check-ins | 5 participants |
| Contingency Management (CM) and NRT (Phase 1) | Treatment Specific Adherence Rates | More than half the check-ins but did not complete all | 5 participants |
| Contingency Management (CM) and NRT (Phase 1) | Treatment Specific Adherence Rates | Less than half the check-ins | 21 participants |
| Contingency Management (CM) and NRT (Phase 1) | Treatment Specific Adherence Rates | 0 check-ins | 15 participants |
| Contingency Management (CM) and NRT (Phase 1) | Treatment Specific Adherence Rates | Completed all check-ins | 0 participants |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Treatment Specific Adherence Rates | Half of the check-ins | 0 participants |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Treatment Specific Adherence Rates | 0 check-ins | 1 participants |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Treatment Specific Adherence Rates | Less than half the check-ins | 9 participants |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Treatment Specific Adherence Rates | More than half the check-ins but did not complete all | 2 participants |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Treatment Specific Adherence Rates | Completed all check-ins | 0 participants |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Treatment Specific Adherence Rates | More than half the check-ins but did not complete all | 4 participants |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Treatment Specific Adherence Rates | Less than half the check-ins | 1 participants |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Treatment Specific Adherence Rates | 0 check-ins | 0 participants |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Treatment Specific Adherence Rates | Half of the check-ins | 1 participants |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Treatment Specific Adherence Rates | Completed all check-ins | 4 participants |