Patch Study - Intervention for HIV Positive Smokers

HIV Clinical Trial

Official title:

Biobehavioral Intervention for Smokers Living With HIV (Human Immunodeficiency Virus)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982772
• Other study ID #: FloridaIU
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2021
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Smoking Cessation

Intervention

Other:
• 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.
• Standard 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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
dr. maria miguez	University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of Smoking Cessation	verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).	3 months
Primary	Rates of Smoking Cessation	verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).	6 months
Primary	Rates of Smoking Cessation	verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).	12 months
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)	6 months
Secondary	Number of Participants With Verified Continuous Abstinence	Verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm	3 months
Secondary	Prevalence of Side Effects-safety	Total number of self reported side effects from Baseline through 6 months.	Baseline-6 months
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.	12 months
Secondary	Number of Participants With Verified Continuous Abstinence	verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm	6 months
Secondary	Number of Participants With Verified Continuous Abstinence	verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm	12 months
Secondary	Prevalence of Side Effects-safety	Total number of self reported side effects from 6 through 12 months.	6 through 12 months