Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS
NCT ID: NCT04218708
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2021-06-17
2024-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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counseling + nicotine replacement therapies NRT
A research assistant (RA) trained in motivational interviewing and qualitative methods will support the PI to deliver counseling sessions and conduct interviews. Briefly, during each visit, with help of the RA, participants will provide exhaled CO and saliva cotinine test, and complete surveys in REDCAP using a tablet, allowing programmed logic checks and skip patterns to minimize burden. The RA will also deliver brief motivational counseling tailored to the participant's readiness to quit and arm in the study (NRT). Participants will also receive their NRT to last them to the following visit based on their baseline smoking.
Nicotine patch and gum
Nicotine patch and gum will be given to subjects in the Nicotine replacement therapy cohort every visit after providing exhaled CO/Saliva cotinine test.
Minnesota Nicotine Withdrawal Scale (MNWS)
The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).
ASSIST (the Alcohol, Smoking and Substance Involvement Screening)
The ASSIST is the Alcohol, Smoking and Substance Involvement Screening Test. It is a brief screening questionnaire to find out about people's use of psychoactive substances (alcohol, smoking and substance involvement).
Counseling
At each study visit, participants will receive counseling protocol that will be based on effective counseling manuals. The PI will train the research assistant who will assist the PI in tailoring the manual to the target group: counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects known to contribute to smoking among PLWHA (e.g., tips on dealing with depression and feeling stigmatized particularly in relation to HIV).
Counseling + Standardized Research E-cigarettes (SREC)
Participants in the SREC arm to practice using the SREC and give them instructions to return with their SREC and used refill tanks on every visit. A research assistant (RA) trained in motivational interviewing and qualitative methods will support the PI to deliver counseling sessions and conduct interviews. Briefly, during each visit, with help of the RA, participants will provide exhaled CO and saliva cotinine test, and complete surveys in REDCAP using a tablet, allowing programmed logic checks and skip patterns to minimize burden. The RA will also deliver brief motivational counseling tailored to the participant's readiness to quit and arm in the study (SREC). Participants will also receive their SREC to last them to the following visit based on their baseline smoking.
Minnesota Nicotine Withdrawal Scale (MNWS)
The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).
ASSIST (the Alcohol, Smoking and Substance Involvement Screening)
The ASSIST is the Alcohol, Smoking and Substance Involvement Screening Test. It is a brief screening questionnaire to find out about people's use of psychoactive substances (alcohol, smoking and substance involvement).
Counseling
At each study visit, participants will receive counseling protocol that will be based on effective counseling manuals. The PI will train the research assistant who will assist the PI in tailoring the manual to the target group: counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects known to contribute to smoking among PLWHA (e.g., tips on dealing with depression and feeling stigmatized particularly in relation to HIV).
NIDA Standardized Research E-cigarettes (SREC)
NIDA SREC has a case with a liquid tank. The e-liquid is supplied in sealed disposable cartridges that deliver \>300 puffs / cartridge. The SREC uses a battery recharged via a micro USB port. A single charge is designed to outlast the capacity of an e-liquid cartridge. The e-liquid is "tobacco" flavored and contains nicotine.
Interventions
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Nicotine patch and gum
Nicotine patch and gum will be given to subjects in the Nicotine replacement therapy cohort every visit after providing exhaled CO/Saliva cotinine test.
Minnesota Nicotine Withdrawal Scale (MNWS)
The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).
ASSIST (the Alcohol, Smoking and Substance Involvement Screening)
The ASSIST is the Alcohol, Smoking and Substance Involvement Screening Test. It is a brief screening questionnaire to find out about people's use of psychoactive substances (alcohol, smoking and substance involvement).
Counseling
At each study visit, participants will receive counseling protocol that will be based on effective counseling manuals. The PI will train the research assistant who will assist the PI in tailoring the manual to the target group: counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects known to contribute to smoking among PLWHA (e.g., tips on dealing with depression and feeling stigmatized particularly in relation to HIV).
NIDA Standardized Research E-cigarettes (SREC)
NIDA SREC has a case with a liquid tank. The e-liquid is supplied in sealed disposable cartridges that deliver \>300 puffs / cartridge. The SREC uses a battery recharged via a micro USB port. A single charge is designed to outlast the capacity of an e-liquid cartridge. The e-liquid is "tobacco" flavored and contains nicotine.
Eligibility Criteria
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Inclusion Criteria
* Smokes at least 10 cigarettes per day on days they smoke CC.
* Motivated to quit smoking (at least a 5 on a 10-point Likert scale).
* Must be able to provide consent
* Agree to be randomized and followed-up with,
* Reside in New York City
* Be willing to use an e-cigarette or NRT for 12 weeks.
Exclusion Criteria
* State diagnosis of any medical condition (angina/heart disease) precluding use of nicotine patch or gum, or by self-report in screening questionnaire
* Reporting using NRTs or e-cigarettes or within the last 30 days
* Have untreated/are undergoing current treatment for psychiatric illness or cognitive impairment at time of initial screening as determined by the subjects' primary care doctor or a licensed study team member in screening
* Report a history of severe or untreated cardiopulmonary disease such as asthma or emphysema.
18 Years
65 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Omar El Shahawy, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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19-01179
Identifier Type: -
Identifier Source: org_study_id