Recruiting

Smoking Cessation

Sponsor:

New York University

Code:

NCT06598397

Conditions

Human Immunodeficiency Virus (HIV)

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Motivational Interviewing (MI) Counseling

Peer Mentoring

Skills-based Text Messaging

Combination NRT

Study Details

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.

Conditions

Human Immunodeficiency Virus (HIV)

Smoking Cessation

Study ID

NCT06598397

Start date

Oct 18, 2024

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Condition 1

Participants will receive the Core Component.

experimental: Condition 2

Participants will receive the Core Component and Combination-NRT intervention.

experimental: Condition 3

Participants will receive the Core Component and Text Messaging intervention.

experimental: Condition 4

Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.

experimental: Condition 5

Participants will receive the Core Component and Peer Mentoring intervention.

experimental: Condition 6

Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.

experimental: Condition 7

Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.

experimental: Condition 8

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.

experimental: Condition 9

Participants will receive the Core Component and Motivational Interviewing Counseling intervention.

experimental: Condition 10

Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.

experimental: Condition 11

Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.

experimental: Condition 12

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.

experimental: Condition 13

Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.

experimental: Condition 14

Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.

experimental: Condition 15

Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.

experimental: Condition 16

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.

Interventions

Motivational Interviewing (MI) Counseling

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

Peer 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.

Skills-based Text Messaging

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

Combination 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.

Primary outcome measure

  • Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care [ Time Frame: 32 weeks ]

Central Contacts and Locations

Central contacts

Jennifer Cantrell, DrPH, MPA

212-998-5797jennifer.cantrell@nyu.edu

Locations

New York University School of Global Public Health

Recruiting

New York, New York, United States, 10003

Contacts

Jennifer Cantrell, DrPH, MPA

212-998-5797jennifer.cantrell@nyu.edu

Rachel Warshaw, MPH

212-992-3948rw1738@nyu.edu

Principal Investigator:

Jennifer Cantrell, DrPH, MPA

More Information

Sponsor

New York University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • MOST
  • multiphase optimization strategy
  • implementation
  • HIV clinical care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by New York University on 2026-04-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.