Human Immunodeficiency Virus (HIV), Smoking Cessation
Conditions
Keywords
MOST, multiphase optimization strategy, implementation, HIV clinical care
Brief summary
This study's long-term goal is to improve clinical outcomes among smokers living with HIV (SLWH) by providing smoking cessation interventions in HIV clinical care that will increase the chances of quitting smoking, limits costs and burden on staff and reach many smokers living with HIV.
Detailed description
This study will utilize Multiphase Optimization Strategy (MOST) to optimize a smoking cessation treatment for HIV clinical care by directly targeting patient barriers to quitting and clinical care barriers to reaching and effectively treating a broad heterogeneous population of smokers living with HIV. The four intervention components will be aimed at barriers to quitting among smokers living with HIV and include Motivational Interviewing; Peer Mentoring; Text-messaging; Combination Nicotine Replacement Therapy. These components have shown promise in research but are under-utilized to help smokers living with HIV quit and have not been tested in an optimization trial. This study will also incorporate data to evaluate the fidelity, acceptability and feasibility of the interventions in the HIV clinical care context in order to identify the most cost-effective, sustainable and scalable tobacco treatment package for the care environment.
Interventions
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
BEHAVIORALPeer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
BEHAVIORALSkills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
DRUGCombination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Sponsors
National Cancer Institute (NCI)
New York University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A full factorial randomized controlled trial using Multiphase Optimization STrategy (MOST) with 4 component interventions, each at 2 levels (off/on), for a total of 16 component conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Status as HIV+ * Age 18 or older * Currently smokes ≥ 5 CPD, on average, in past month * Positive for salivary cotinine * Able to understand the nature of the study and the consenting process * Is engaged in HIV clinical care * Living in larger NYC metropolitan area currently and for the next 6-8 months
Exclusion criteria
* Suffers from any medical condition or contraindication precluding use of nicotine replacement therapy * Current use of any tobacco cessation medications (varenicline, NRT patch, nicotine gum, lozenge, spray or inhaler, or bupropion) * Currently participating in a smoking cessation program * Pregnant or nursing and plans to be in next 6 months * Has schizophrenia/schizo-affective disorder * Does not have a functioning mobile phone that can receive text messages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care | 24-32 weeks | Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day PPA | 24-32 weeks | Self-reported 30-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative cotinine assessment |
| Self-reported 7-day PPA | 6-10 and 12-16 weeks | Self-reported 7-day cigarette PPA (point prevalence abstinence) |
| Quit attempts | 6-10, 12-16, and 24-32 weeks | Number of quit attempts (of at least 24 hours) in last 7 days and since last assessment |
Countries
United States
Contacts
Primary ContactJennifer Cantrell, DrPH, MPA
Outcome results
None listed