Clinical trial NCT04327921: A Peer Navigator Model to Improve Quit Attempts and Smoking Cessation Rates Among HIV-positive Smokers
Official title: A Peer Navigator Model to Improve Quit Attempts and Smoking Cessation Rates Among HIV-positive Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
HIV Virus
smoking
smoking cessation
peer navigator
social support
self efficacy
quit smoking
smoking treatment
quitting smoking
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and Acceptability
timeFrame: Week 24
measure: Quit Attempts
timeFrame: Week 24
measure: Point prevalence abstinence
timeFrame: Week 24
measure: Treatment Satisfaction
timeFrame: Week 24
Secondary outcomes:
measure: Change in social support for quitting from baseline to week 12
timeFrame: Week 12
measure: Change in self-efficacy for smoking cessation from baseline to week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Immunology Center
state: Rhode Island
Study officials:
affiliation: Brown University
name: Patricia A Cioe, PhD
role: PRINCIPAL_INVESTIGATOR
References: