A Peer Navigator Model to Improve Quit Attempts and Smoking Cessation Rates Among HIV-positive Smokers

NCT04327921 | Completed DMC

• 1 other identifier: 1R21CA243906-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Effective antiretroviral therapy has led to an increased lifespan for persons living with HIV (PLWH), when diagnosed early and engaged in care. This transition to HIV as a chronic illness has resulted in cancer being a leading cause of morbidity and mortality in PLWH. The increased risk of cancer is due in part to a high prevalence of risk factors for cancer - most notably tobacco use. Smoking prevalence is substantially higher in PLWH (40%) compared with the general population (15%) and is associated with increased rates of lung cancers, and other malignancies. Furthermore, combined data from three national surveys showed that the proportion of deaths attributed to AIDS-defining cancers decreased from 2000 to 2010, while the proportion of deaths attributed to non-AIDS-related cancers increased significantly over the same period of time. Smoking cessation studies in PLWH have demonstrated disappointing outcomes, with low quit rates, poor adherence to therapy, and a lack of sustained abstinence. In an HIV and smoking review, it was suggested that research develop focused interventions that targets: 1) adherence to smoking cessation medications, 2) self-confidence for quitting, and 3) social support for smoking cessation. The investigators are proposing is specifically designed to address these 3 targets by using peer navigators to facilitate access to effective smoking treatments and to support abstinence. This study is highly innovative in its application of peer navigators to improve HIV-positive smokers' access to and utilization of existing resources to improve smoking cessation outcomes. The proposed study will provide initial evidence of whether targeting mechanisms of behavior change (self-efficacy and social support) during a quit attempt using peer navigators is effective at improving outcomes. If demonstrated to be successful, it has significant implications for the transformation of current clinical approaches to smoking cessation in HIV clinics. This approach could then be widely implemented to improve outcomes in this group of smokers.

Conditions

HIV

Keywords

HIV; HIV Virus; smoking; smoking cessation; peer navigator; social support; self efficacy; quit smoking; smoking treatment; quitting smoking

Outcome Measures

Primary Outcomes (4)

• Feasibility and Acceptability

  Session attendance (recorded as a continuous variable ranging from 1 to 4 study sessions).

  Week 24

• Quit Attempts

  A quit attempt is defined as a period of 24 hours of no cigarette smoking

  Week 24

• Point prevalence abstinence

  Biochemically verified 7-day point-prevalence abstinence. Point-prevalence abstinence will be verified by saliva cotinine radioimmune assay analysis (cutoff value of \< 15 ng/ml) for stated abstinence of 7 days or longer in those not currently using NRT or other nicotine-containing products. Self-report will always be overridden by objective verification of abstinence in the final analyses. Breath samples for CO will be obtained at each study visit.

  Week 24

• Treatment Satisfaction

  CSQ-8 will be used to compare treatment satisfaction by study condition.

  Week 24

Secondary Outcomes (2)

• Change in social support for quitting from baseline to week 12

  Week 12

• Change in self-efficacy for smoking cessation from baseline to week 12

  Week 12

Study Arms (2)

peer navigation social support for smoking cessation

EXPERIMENTAL

36 HIV-positive smokers will have a 30-minute session with the study nurse to discuss smoking cessation. They will also discuss the importance of social support for quitting and the role of a Peer Navigator. Those participants who set a quit date will choose medication/s in collaboration with the nurse and/or physician. The Peer Navigator will be introduced and will reinforce adherence to medication. The Peer Navigator will ensure that the patient picks up the medication, and will help to manage side effects via physician/nurse consultation. The Peer Navigator will provide social support for quitting via weekly phone calls for 12 weeks.

Behavioral: Peer navigation social support for smoking cessation

Standard Condition

ACTIVE COMPARATOR

36 HIV-positive smokers will receive standard care. Participants will meet for a 30-minute session with a study nurse. They will receive counseling based on the 5A's. The nurse will ask about current smoking habits, advise the participant to quit, assess readiness to quit, and assist by providing resources (community programs, Quit line phone number). The nurse will calculate Lung Age which will serve as a motivation tool to encourage smokers to quit. Those willing to set a quit date will be instructed to call their physician for cessation medication and will provided with the National Cancer Institute self-help pamphlet. Those participants not willing to set a quit date will be instructed to contact their physician when they are ready.

Behavioral: Standard Condition

Interventions

Peer navigation social support for smoking cessation BEHAVIORAL

Standard guidelines will be used for brief advice for smoking cessation based on the 5A's. Also, motivational interviewing/guidance will also be used to determine whether enhanced treatment (using a Peer Navigator to navigate smoking cessation, obtain medication and treatment, improve adherence to treatment, and provide social support for quitting) will increase participant's quit attempts and smoking cessation rates.

peer navigation social support for smoking cessation

Standard Condition BEHAVIORAL

Standard guidelines will be used for brief advice for smoking cessation based on the 5A's.

Standard Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with HIV
• at least 18 years of age
• smoke at least 5 cigarettes per day for longer than one year
• have an exhaled carbon monoxide (CO) level greater than 5 at baseline

You may not qualify if:

• currently using pharmacotherapy for smoking cessation
• an unstable medical or psychiatric condition (defined as a medical or psychiatric hospitalization in the 30 days prior to enrollment)
• experiencing psychotic symptoms
• past-month suicidal ideation or past-year suicide attempt
• pregnant or nursing
• Blood pressure reading greater than 160/100
• Heart Rate less than 45 or greater than 115
• family/household member already enrolled

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Miriam Immunology Center

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

• Cioe PA, Pinkston M, Stang GS, Tashima KT, Kahler CW. Peer Navigation for Smoking Cessation in People With HIV Who Smoke: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2025 Feb 24;27(3):517-524. doi: 10.1093/ntr/ntae214.

  PMID: 39251402 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Patricia A Cioe, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant will not be aware of study condition of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Once the baseline interview is complete, the principal investigator, who is not involved in conducting assessments, will randomize eligible participants to one of two study conditions. Urn randomization will be used to ensure the groups are balanced on gender and Fagerström Test of Nicotine Dependence (FTND) score. The Research Assistant will not be informed of treatment condition assignment. All participants will be scheduled for a week 1 session with a study nurse within one week of the baseline appointment. The nurse will use a detailed counseling manual to ensure standardization of treatment delivery.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 31, 2020
• Study Start: January 14, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)