HIV, Smoking Cessation
Conditions
Keywords
Nicotine Replacement, Smoking, HIV
Brief summary
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. To test researchers proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines + nicotine replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.
Detailed description
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. This will be accomplished by assessing: 1) pre-trial plasma levels, 2) doing genotyping, which to researchers knowledge has not been used in cessation studies among people living with HIV (PLWH), and 3) providing tailored feedback to the participants, based on the assumption that the higher the knowledge and perception of risk, the higher the interest in modifying a risky behavior(s). To test researchers proposed model based in proven smoking prevention and control methods 600 PLWH ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines will consist on brief advice + nicotine replacement therapy, versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy (NRT). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day. The knowledge gained here has the potential to provide a more complete bio-behavioral model to the intervention field. The proposed study if successful will provide a new tailored, replicable, and manual-based intervention for people living with HIV. It can also provide much need it information in regards to key mediators and moderators of smoking cessation interventions in this vulnerable population. Researchers long term goal is to reduce the burden of one of the most devastating causes of morbi-mortality in researchers time and improve their quality of life. The study could also pave the path to use a similar model to tailor smoking interventions for other populations (e.g., menthol users, older women, adolescents, older adults).
Interventions
OTHERCombination Therapy
Brief behavioral intervention The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
OTHERStandard Care Intervention
Brief Behavioral Intervention The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks
Sponsors
University of Miami
dr. maria miguez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV infected smokers * 18 years of age and older * Fluent in English or Spanish * Able to consent * Ready to quit smoking
Exclusion criteria
* Psychotic or disabling psychiatric disorders * Six months post-myocardial infarction or stroke * Diabetes requiring insulin * Treatment for vascular problems * Non-treated hypertension, * Severe liver or kidney disease * History of allergies to the nicotine patches * Severe eczema or psoriasis * Temporal-mandibular joint disease or dental appliances * Pregnant women or women that are breastfeeding * Subjects participating in other interventions/research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Smoking Cessation | 3 months | verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Outcomes | 6 months | The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves: * CD4 (counts and percentage). * HIV Viral load (logs). * Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute). * Anthropometric measures \[Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches\]. * In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) |
| Number of Participants With Verified Continuous Abstinence | 3 months | Verified continuous abstinence using a breathalyzer carbon monoxide \< 10ppm |
| Prevalence of Side Effects-safety | Baseline-6 months | Total number of self reported side effects from Baseline through 6 months. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited with flyers and by referrals.
Pre-assignment details
488 participants signed consent forms, a total 11 were excluded (6 did not meet smoking criteria, 3 were not compliant, and 2 had pre-existing medical conditions).
Participants by arm
| Arm | Count |
|---|---|
| Tailored Combination Therapy Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks. | 245 |
| Standard Care Intervention Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks | 243 |
| Total | 488 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12M Follow-Up | Lost to Follow-up | 11 | 5 |
| 1M Follow-Up | Lost to Follow-up | 21 | 18 |
| 3M Follow-Up | Lost to Follow-up | 17 | 11 |
| 6M Follow-Up | Lost to Follow-up | 11 | 9 |
| Intervention | Lost to Follow-up | 19 | 13 |
Baseline characteristics
| Characteristic | Tailored Combination Therapy | Standard Care Intervention | Total |
|---|---|---|---|
| Age, Continuous | 50.1 years | 51.1 years | 51.1 years |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 33 Participants | 21 Participants | 54 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black | 197 Participants | 202 Participants | 399 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 15 Participants | 20 Participants | 35 Participants |
| Region of Enrollment United States | 245 Participants | 243 Participants | 488 Participants |
| Sex: Female, Male Female | 98 Participants | 114 Participants | 212 Participants |
| Sex: Female, Male Male | 147 Participants | 129 Participants | 276 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 245 | 2 / 243 |
| other Total, other adverse events | 101 / 245 | 83 / 243 |
| serious Total, serious adverse events | 0 / 245 | 0 / 243 |
Outcome results
Primary
Rates of Smoking Cessation
verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).
Time frame: 6 months
Population: This is the total number of participants in each arm that quit smoking at 6 months. However due to the pandemic we could not verified with biomarkers
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Tailored Combination Therapy | Rates of Smoking Cessation | 40 Number of pts that quit |
| Standard Care Intervention | Rates of Smoking Cessation | 28 Number of pts that quit |
Primary
Rates of Smoking Cessation
verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).
Time frame: 12 months
Population: This is the total number of participants in each arm that quit smoking at 12 months.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Tailored Combination Therapy | Rates of Smoking Cessation | 32 Number of pts that quit |
| Standard Care Intervention | Rates of Smoking Cessation | 28 Number of pts that quit |
Primary
Rates of Smoking Cessation
verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).
Time frame: 3 months
Population: This is the total number of participants in each arm that quit smoking at 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Combination Therapy | Rates of Smoking Cessation | 57 Participants |
| Standard Care Intervention | Rates of Smoking Cessation | 46 Participants |
Secondary
Change in Clinical Outcomes
The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves: * CD4 (counts and percentage). * HIV Viral load (logs). * Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute). * Anthropometric measures \[Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches\]. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) \- In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.
Time frame: 12 months
Population: Quality of Life change at 12 months. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Combination Therapy | Change in Clinical Outcomes | 0.85 score on a scale/change | Standard Deviation 5.9 |
| Standard Care Intervention | Change in Clinical Outcomes | 0.82 score on a scale/change | Standard Deviation 5.4 |
Secondary
Change in Clinical Outcomes
The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves: * CD4 (counts and percentage). * HIV Viral load (logs). * Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute). * Anthropometric measures \[Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches\]. * In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
Time frame: 6 months
Population: Quality of Life change at 6 months.~Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Combination Therapy | Change in Clinical Outcomes | -1.9 score on a scale/change | Standard Deviation 8.8 |
| Standard Care Intervention | Change in Clinical Outcomes | 0.38 score on a scale/change | Standard Deviation 7.2 |
Secondary
Number of Participants With Verified Continuous Abstinence
verified continuous abstinence using a breathalyzer carbon monoxide \< 10ppm
Time frame: 6 months
Population: Verified abstinence at 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Combination Therapy | Number of Participants With Verified Continuous Abstinence | 49 Participants |
| Standard Care Intervention | Number of Participants With Verified Continuous Abstinence | 40 Participants |
Secondary
Number of Participants With Verified Continuous Abstinence
Verified continuous abstinence using a breathalyzer carbon monoxide \< 10ppm
Time frame: 3 months
Population: Verified abstinence at 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Combination Therapy | Number of Participants With Verified Continuous Abstinence | 57 Participants |
| Standard Care Intervention | Number of Participants With Verified Continuous Abstinence | 46 Participants |
Secondary
Number of Participants With Verified Continuous Abstinence
verified continuous abstinence using a breathalyzer carbon monoxide \< 10ppm
Time frame: 12 months
Population: Verified abstinence at 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Combination Therapy | Number of Participants With Verified Continuous Abstinence | 32 Participants |
| Standard Care Intervention | Number of Participants With Verified Continuous Abstinence | 28 Participants |
Secondary
Prevalence of Side Effects-safety
Total number of self reported side effects from 6 through 12 months.
Time frame: 6 through 12 months
Population: Total of number of participants in the Tailored \& Standard arms.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Combination Therapy | Prevalence of Side Effects-safety | 31 side effects |
| Standard Care Intervention | Prevalence of Side Effects-safety | 33 side effects |
Secondary
Prevalence of Side Effects-safety
Total number of self reported side effects from Baseline through 6 months.
Time frame: Baseline-6 months
Population: Total of number of participants in the Tailored \& Standard arms.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Combination Therapy | Prevalence of Side Effects-safety | 70 side effects |
| Standard Care Intervention | Prevalence of Side Effects-safety | 50 side effects |