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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 | No Intervention | Participants will receive the Core Component. | |
| Condition 2 | Experimental | Participants will receive the Core Component and Combination-NRT intervention. |
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| Condition 3 | Experimental | Participants will receive the Core Component and Text Messaging intervention. |
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| Condition 4 | Experimental | Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions. |
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| Condition 5 | Experimental | Participants will receive the Core Component and Peer Mentoring intervention. |
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| Condition 6 | Experimental | Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported 30-day PPA | Self-reported 30-day cigarette PPA (point prevalence abstinence) | 32 weeks |
| Self-reported 7-day PPA | Self-reported 7-day cigarette PPA (point prevalence abstinence) with carbon monoxide verification (<=6 ppm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Cantrell, DrPH, MPA | Contact | 212-998-5797 | jennifer.cantrell@nyu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Global Public Health | Recruiting | New York | New York | 10003 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2026 | Feb 26, 2026 |
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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.
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| Condition 7 | Experimental | Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions. |
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| Condition 8 | Experimental | Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions. |
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| Condition 9 | Experimental | Participants will receive the Core Component and Motivational Interviewing Counseling intervention. |
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| Condition 10 | Experimental | Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions. |
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| Condition 11 | Experimental | Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions. |
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| Condition 12 | Experimental | Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions. |
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| Condition 13 | Experimental | Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions. |
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| Condition 14 | Experimental | Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions. |
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| Condition 15 | Experimental | Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions. |
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| Condition 16 | Experimental | Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions. |
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| 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. |
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| Skills-based Text Messaging | Behavioral | NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov. |
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| 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. |
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| 8 and 16 weeks |
| Self-reported 30-day PPA | Self-reported 30-day cigarette PPA (point prevalence abstinence) | 8 and 16 weeks |
| Quit attempts | Number of quit attempts (of at least 24 hours) in last 7 days and since last assessment | 8, 16, and 32 weeks |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003153 | Community Health Services |
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