A Peer Navigator Model to Improve Quit Attempts and Smoking Cessation Rates Among HIV-positive Smokers
Public ClinicalTrials.gov record NCT04327921. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04327921
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Interventions
- Peer navigation social support for smoking cessation Behavioral
- Standard Condition Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 13, 2020
- Primary completion
- Dec 30, 2021
- Completion
- Dec 30, 2021
- Last update posted
- Mar 1, 2022
2020 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Miriam Immunology Center | Providence | Rhode Island | 02912 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04327921, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 1, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04327921 live on ClinicalTrials.gov.