HIVP-NAVNCT04327921
A Peer Navigator Model to Improve Quit Attempts and Smoking Cessation Rates Among HIV-positive Smokers
A study testing Peer navigation social support for smoking cessation and Standard Condition in people with HIV, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Peer navigation social support for smoking cessation and Standard Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Miriam Immunology Center
Providence, Rhode Island, 02912
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Peer navigation social support for smoking cessation, Standard Condition
- Keywords
- HIV, HIV Virus, smoking, smoking cessation, peer navigator, social support, self efficacy, quit smoking, smoking treatment, quitting smoking
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer navigation social support for smoking cessationBehavioural
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 ConditionBehavioural
Standard guidelines will be used for brief advice for smoking cessation based on the 5A's.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability
Session attendance (recorded as a continuous variable ranging from 1 to 4 study sessions).
Measured: Week 24
Quit Attempts
A quit attempt is defined as a period of 24 hours of no cigarette smoking
Measured: 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.
Measured: Week 24
Treatment Satisfaction
CSQ-8 will be used to compare treatment satisfaction by study condition.
Measured: Week 24
Secondary outcomes (2)
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).
Measured: Week 12
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start14 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Cioe, Brown University
- Investigators
- Patricia A Cioe, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327921
- Sponsor's protocol ID
- 1R21CA243906-01
- Acronym
- P-NAV
- Status last verified
- Feb 2022
- First submitted
- 2 Mar 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39251402
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer Navigator Model to Improve Quit Attempts and Smoking Cessation Rates Among HIV-positive Smokers
- ClinicalTrials.gov ID
- NCT04327921
- Acronym / sponsor ID
- P-NAV / 1R21CA243906-01
- Conditions
- HIV
- Keywords
- HIV, HIV Virus, smoking, smoking cessation, peer navigator, social support, self efficacy, quit smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| peer navigation social support for smoking cessation | Experimental | Behavioral: Peer navigation social support for smoking cessation36 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. |
| Standard Condition | Active comparator | Behavioral: Standard Condition36 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer navigation social support for smoking cessationStandard 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. | Behavioural | peer navigation social support for smoking cessation |
| Standard ConditionStandard guidelines will be used for brief advice for smoking cessation based on the 5A's. | Behavioural | Standard Condition |
Primary outcome
Feasibility and Acceptability
Time frame: Week 24
Session attendance (recorded as a continuous variable ranging from 1 to 4 study sessions).
Quit Attempts
Time frame: Week 24
A quit attempt is defined as a period of 24 hours of no cigarette smoking
Point prevalence abstinence
Time frame: Week 24
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.
Treatment Satisfaction
Time frame: Week 24
CSQ-8 will be used to compare treatment satisfaction by study condition.
2 secondary outcomes
Change in social support for quitting from baseline to week 12
Time frame: Week 12
Change in self-efficacy for smoking cessation from baseline to week 12
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 39251402Cioe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A Cioe, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer navigation social support for smoking cessation and Standard Condition in people with HIV, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability (time frame: Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.