Human Immunodeficiency Virus (HIV)Phase 4NCT06598397
Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care
A Phase 4 study testing Motivational Interviewing (MI) Counseling, Peer Mentoring and Skills-based Text Messaging in people with Human Immunodeficiency Virus (HIV) and Smoking Cessation, run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Smoking Cessation
- What is being tested?
- Motivational Interviewing (MI) Counseling, Peer Mentoring and Skills-based Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York University School of Global Public Health
New York, New York, 10003
Jennifer Cantrell, DrPH, MPA, 212-998-5797, jennifer.cantrell@nyu.edu
Rachel Warshaw, MPH, 212-992-3948 ext. 23948, rw1738@nyu.edu
About this study
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.
Read the 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.
- Being tested
- Motivational Interviewing (MI) Counseling, Peer Mentoring, Skills-based Text Messaging, Combination NRT
- Keywords
- MOST, multiphase optimization strategy, implementation, HIV clinical care
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI) CounselingBehavioural
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Peer MentoringBehavioural
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 MessagingBehavioural
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Combination NRTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | No intervention | Participants will receive the Core Component. |
| Condition 2 | Experimental | Participants will receive the Core Component and Combination-NRT intervention. Receives: Drug: Combination NRT |
| Condition 3 | Experimental | Participants will receive the Core Component and Text Messaging intervention. Receives: Behavioral: Skills-based Text Messaging |
| Condition 4 | Experimental | Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions. Receives: Behavioral: Skills-based Text Messaging; Drug: Combination NRT |
| Condition 5 | Experimental | Participants will receive the Core Component and Peer Mentoring intervention. Receives: Behavioral: Peer Mentoring |
| Condition 6 | Experimental | Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions. Receives: Behavioral: Peer Mentoring; Drug: Combination NRT |
| Condition 7 | Experimental | Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions. Receives: Behavioral: Peer Mentoring; Behavioral: Skills-based Text Messaging |
| Condition 8 | Experimental | Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions. Receives: Behavioral: Peer Mentoring; Behavioral: Skills-based Text Messaging; Drug: Combination NRT |
| Condition 9 | Experimental | Participants will receive the Core Component and Motivational Interviewing Counseling intervention. Receives: Behavioral: Motivational Interviewing (MI) Counseling |
| Condition 10 | Experimental | Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions. Receives: Behavioral: Motivational Interviewing (MI) Counseling; Drug: Combination NRT |
| Condition 11 | Experimental | Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions. Receives: Behavioral: Motivational Interviewing (MI) Counseling; Behavioral: Skills-based Text Messaging |
| Condition 12 | Experimental | Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions. Receives: Behavioral: Motivational Interviewing (MI) Counseling; Behavioral: Skills-based Text Messaging; Drug: Combination NRT |
| Condition 13 | Experimental | Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions. Receives: Behavioral: Motivational Interviewing (MI) Counseling; Behavioral: Peer Mentoring |
| Condition 14 | Experimental | Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions. Receives: Behavioral: Motivational Interviewing (MI) Counseling; Behavioral: Peer Mentoring; Drug: Combination NRT |
| Condition 15 | Experimental | Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions. Receives: Behavioral: Motivational Interviewing (MI) Counseling; Behavioral: Peer Mentoring; Behavioral: Skills-based Text Messaging |
| Condition 16 | Experimental | Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions. Receives: Behavioral: Motivational Interviewing (MI) Counseling; Behavioral: Peer Mentoring; Behavioral: Skills-based Text Messaging; Drug: Combination NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 32 weeks
Secondary outcomes (4)
Self-reported 30-day PPA
Self-reported 30-day cigarette PPA (point prevalence abstinence)
Measured: 32 weeks
Self-reported 7-day PPA
Self-reported 7-day cigarette PPA (point prevalence abstinence) with carbon monoxide verification (<=6 ppm)
Measured: 8 and 16 weeks
Self-reported 30-day PPA
Self-reported 30-day cigarette PPA (point prevalence abstinence)
Measured: 8 and 16 weeks
Quit attempts
Number of quit attempts (of at least 24 hours) in last 7 days and since last assessment
Measured: 8, 16, and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Oct 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598397
- Sponsor's protocol ID
- CA268932
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care
- ClinicalTrials.gov ID
- NCT06598397
- Acronym / sponsor ID
- CA268932
- Keywords
- MOST, multiphase optimization strategy, implementation, HIV clinical care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
- 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.
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | No intervention | –Participants will receive the Core Component. |
| Condition 2 | Experimental | Drug: Combination NRTParticipants will receive the Core Component and Combination-NRT intervention. |
| Condition 3 | Experimental | Behavioral: Skills-based Text MessagingParticipants will receive the Core Component and Text Messaging intervention. |
| Condition 4 | Experimental | Behavioral: Skills-based Text Messaging, Drug: Combination NRTParticipants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions. |
| Condition 5 | Experimental | Behavioral: Peer MentoringParticipants will receive the Core Component and Peer Mentoring intervention. |
| Condition 6 | Experimental | Behavioral: Peer Mentoring, Drug: Combination NRTParticipants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions. |
| Condition 7 | Experimental | Behavioral: Peer Mentoring, Behavioral: Skills-based Text MessagingParticipants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions. |
| Condition 8 | Experimental | Behavioral: Peer Mentoring, Behavioral: Skills-based Text Messaging, Drug: Combination NRTParticipants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions. |
| Condition 9 | Experimental | Behavioral: Motivational Interviewing (MI) CounselingParticipants will receive the Core Component and Motivational Interviewing Counseling intervention. |
| Condition 10 | Experimental | Behavioral: Motivational Interviewing (MI) Counseling, Drug: Combination NRTParticipants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions. |
| Condition 11 | Experimental | Behavioral: Motivational Interviewing (MI) Counseling, Behavioral: Skills-based Text MessagingParticipants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions. |
| Condition 12 | Experimental | Behavioral: Motivational Interviewing (MI) Counseling, Behavioral: Skills-based Text Messaging, Drug: Combination NRTParticipants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions. |
| Condition 13 | Experimental | Behavioral: Motivational Interviewing (MI) Counseling, Behavioral: Peer MentoringParticipants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions. |
| Condition 14 | Experimental | Behavioral: Motivational Interviewing (MI) Counseling, Behavioral: Peer Mentoring, Drug: Combination NRTParticipants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions. |
| Condition 15 | Experimental | Behavioral: Motivational Interviewing (MI) Counseling, Behavioral: Peer Mentoring, Behavioral: Skills-based Text MessagingParticipants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions. |
| Condition 16 | Experimental | Behavioral: Motivational Interviewing (MI) Counseling, Behavioral: Peer Mentoring, Behavioral: Skills-based Text Messaging, Drug: Combination NRTParticipants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing (MI) CounselingSix sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment. | Behavioural | Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 9 |
| Peer MentoringEight 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. | Behavioural | Condition 13, Condition 14, Condition 15, Condition 16, Condition 5, Condition 6, Condition 7, Condition 8 |
| Skills-based Text MessagingNCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov. | Behavioural | Condition 11, Condition 12, Condition 15, Condition 16, Condition 3, Condition 4, Condition 7, Condition 8 |
| Combination NRTIf 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. | Drug | Condition 10, Condition 12, Condition 14, Condition 16, Condition 2, Condition 4, Condition 6, Condition 8 |
Primary outcome
Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care
Time frame: 32 weeks
Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine
4 secondary outcomes
Self-reported 30-day PPA
Time frame: 32 weeks
Self-reported 7-day PPA
Time frame: 8 and 16 weeks
Self-reported 30-day PPA
Time frame: 8 and 16 weeks
Quit attempts
Time frame: 8, 16, and 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motivational Interviewing (MI) Counseling, Peer Mentoring and Skills-based Text Messaging in people with Human Immunodeficiency Virus (HIV) and Smoking Cessation, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Cantrell, DrPH, MPA (212-998-5797, jennifer.cantrell@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.