Health TrialsbyHealthPanel

Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

ConditionsHuman Immunodeficiency Virus (HIV)Smoking Cessation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNew York University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Status as HIV+

Age 18 or older

Currently smokes ≥ 5 CPD, on average, in past month

Positive for salivary cotinine

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Motivational Interviewing (MI) Counseling

    Behavioral

    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.

  • Peer Mentoring

    Behavioral

    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.

  • Skills-based Text Messaging

    Behavioral

    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.

  • Combination NRT

    Drug

    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.

Treatment groups

500 Participants
are divided into 16 treatment groups

16

Treatment groups

See each treatment group below.

Group A: Condition 1No intervention 0 interventions
Group B: Condition 2Experimental treatment 1 intervention
Group C: Condition 3Experimental treatment 1 intervention
Group D: Condition 4Experimental treatment 2 interventions
Group E: Condition 5Experimental treatment 1 intervention
Group F: Condition 6Experimental treatment 2 interventions
Group G: Condition 7Experimental treatment 2 interventions
Group H: Condition 8Experimental treatment 3 interventions
Group I: Condition 9Experimental treatment 1 intervention
Group J: Condition 10Experimental treatment 2 interventions
Group K: Condition 11Experimental treatment 2 interventions
Group L: Condition 12Experimental treatment 3 interventions
Group M: Condition 13Experimental treatment 2 interventions
Group N: Condition 14Experimental treatment 3 interventions
Group O: Condition 15Experimental treatment 3 interventions
Group P: Condition 16Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care

Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine

Time frame
32 weeks

Secondary outcomes

1

Self-reported 30-day PPA

Self-reported 30-day cigarette PPA (point prevalence abstinence)

Time frame
32 weeks
2

Self-reported 7-day PPA

Self-reported 7-day cigarette PPA (point prevalence abstinence) with carbon monoxide verification (\<=6 ppm)

Time frame
8 and 16 weeks
3

Self-reported 30-day PPA

Self-reported 30-day cigarette PPA (point prevalence abstinence)

Time frame
8 and 16 weeks
4

Quit attempts

Number of quit attempts (of at least 24 hours) in last 7 days and since last assessment

Time frame
8, 16, and 32 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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