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

HIV Clinical Trial

— P-NAV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327921
• Other study ID #: 1R21CA243906-01
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Aims - The specific aims are to examine: (1) the feasibility, acceptability, and initial efficacy of Peer Navigation for Social Support - Smoking in a 24-week randomized pilot study; (2) to compare the effect of Peer Navigation for Social Support, relative to standard care, on mechanisms thought to underlie smoking abstinence in HIV-positive smokers.

Methodology - The investigators will adapt an existing, highly effective peer navigation training program to increase engagement in care within the HIV clinic. The peer navigator for smoking cessation will be a former daily smoker who quit smoking 1-2 years ago and has remained smoke-free. The investigators will train the peer navigator, enroll 6 HIV-positive smokers to test the intervention, and finalize the protocol. The investigators will refine the protocol based on feedback from the peer navigator, the 6 participants, and the study nurses. Next, the investigators will conduct a pilot randomized trial (N = 72) to test the feasibility, acceptability, and initial efficacy of peer navigation in a randomized, 2-group, repeated measures design. The investigators will randomize 36 HIV-positive smokers to each condition: Peer Navigation or standard care. Assessments will be collected at baseline, and at 4-, 12-, and 24-weeks.

Participant Population - Participants for this study will include 78 participants recruited from Providence, Rhode Island.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• HIV
• HIV Seropositivity

Intervention

Behavioral:
• Peer navigation social support for smoking cessation
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.
• Standard Condition
Standard guidelines will be used for brief advice for smoking cessation based on the 5A's.

Locations

Country	Name	City	State
United States	Miriam Immunology Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Acceptability	Session attendance (recorded as a continuous variable ranging from 1 to 4 study sessions).	Week 24
Primary	Quit Attempts	A quit attempt is defined as a period of 24 hours of no cigarette smoking	Week 24
Primary	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
Primary	Treatment Satisfaction	CSQ-8 will be used to compare treatment satisfaction by study condition.	Week 24
Secondary	Change in social support for quitting from baseline to week 12	Assessed using the Partner Interaction Questionnaire, which assesses negative and positive support for quitting. Participants will be instructed to include all forms of support for quitting (including PN support if assigned to the PNSS-S condition).	Week 12
Secondary	Change in self-efficacy for smoking cessation from baseline to week 12	Contemplation Ladder, a one-item Likert-type scale (rating 1-10). In participants who set a quit date, adherence to pharmacotherapy will be measured via participant self-report and pharmacy refill report at each study session.	Week 12