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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT plus NRT Group-Phase 1 | Experimental | 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. |
|
| CM plus NRT Group-Phase1 | Experimental | 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. |
|
| MT plus NRT with additional CM Group-Phase2 | Experimental | Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks. |
|
| CM plus NRT with additional MT Group-Phase2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Therapy | Drug | 6 weeks of Nicotine replacement patches |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks (end of treatment), and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Treatment Specific Adherence Rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taghrid A. Asfar, MD, MSPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks. 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. 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. |
| FG003 | Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 Participants |
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| Phase 2 Participants |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only those who participated in their treatment (completed at least one session). | Posted | Number | participants | 4 weeks (end of treatment), and 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Taghrid Asfar | University of Miami | +1 (901) 371-7229 | tasfar@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2025 | May 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
|
| Mindfulness Training Smoking Cessation Intervention | Behavioral | 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. |
|
| Contingency Management Smoking Cessation Intervention | Behavioral | 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. |
|
Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).
| 3 months |
| Did not attend sessions after being randomized |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks. 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. 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. |
| OG003 | Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks. 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. 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. |
|
|
| 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. | All participants who enrolled and were randomized. | Posted | Number | percentage of patients | 3 months |
|
|
|
| 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). | 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. | Posted | Number | participants | 3 months |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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. | 0 | 46 | 0 | 46 | 0 | 46 |
| EG002 | Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks. 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. 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks. 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. 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D007239 |
| Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Less than half the check-ins |
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| Half of the check-ins |
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| More than half the check-ins but did not complete all |
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| Completed all check-ins |
|