SmokingNCT02190643
Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers
A study testing Cessation counseling with adherence focus and Cessation counseling without adherence focus in people with Smoking, run by RAND at 1 site in United States.
Trial summary
The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive smokers focused on improving adherence to using the nicotine skin patch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Cessation counseling with adherence focus and Cessation counseling without adherence focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2016
- 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
- 18 years or older
- Latino
- HIV positive
- current, daily smoker
- ready to set quit date in next 30 days
- willing to try the nicotine patch
Who cannot join
- suffering from any medical condition which would prevent using the nicotine patch
- currently using other tobacco products or e-cigarettes
- currently receiving counseling or medication to quit or reduce smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
Bienestar Human Services Inc
Los Angeles, California, 90022
About this study
The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive smokers focused on improving adherence to using the nicotine skin patch.
- Conditions
- Smoking
- Being tested
- Cessation counseling with adherence focus, Cessation counseling without adherence focus
- Keywords
- Smoking, HIV, Latino, Cessation, Nicotine patch
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation counseling with adherence focusBehavioural
Cessation counseling without adherence focusBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Adherence condition | Experimental | Brief smoking cessation counseling session (based on 5 A's approach) that includes a module focused on improving adherence to using the nicotine patch, plus 8-week supply of nicotine patches. Receives: Behavioral: Cessation counseling with adherence focus |
| Standard condition | Active comparator | Brief smoking cessation counseling session (based on 5 A's approach) that does not include a module focused on improving nicotine patch adherence, plus 8-week supply of nicotine patches. Receives: Behavioral: Cessation counseling without adherence focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous abstinence
No smoking from the target quit date through the 3-month follow-up
Measured: 3 months post-quit date
biochemically-verified 7-day point prevalence abstinence
No smoking in the 7 prior days
Measured: 3 months post-quit date
Secondary outcomes (1)
Nicotine patch adherence
Measured: 3 months post-quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190643
- Sponsor's protocol ID
- R21DA035629
- Status last verified
- Apr 2016
- First submitted
- 11 Jul 2014
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers
- ClinicalTrials.gov ID
- NCT02190643
- Acronym / sponsor ID
- R21DA035629
- Conditions
- Smoking
- Keywords
- Smoking, HIV, Latino, Cessation, Nicotine patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jul 2014 (estimated)
- 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.
The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive smokers focused on improving adherence to using the nicotine skin patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence condition | Experimental | Behavioral: Cessation counseling with adherence focusBrief smoking cessation counseling session (based on 5 A's approach) that includes a module focused on improving adherence to using the nicotine patch, plus 8-week supply of nicotine patches. |
| Standard condition | Active comparator | Behavioral: Cessation counseling without adherence focusBrief smoking cessation counseling session (based on 5 A's approach) that does not include a module focused on improving nicotine patch adherence, plus 8-week supply of nicotine patches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Latino
- HIV positive
- current, daily smoker
- ready to set quit date in next 30 days
Key exclusion criteria (3 listed)
- suffering from any medical condition which would prevent using the nicotine patch
- currently using other tobacco products or e-cigarettes
- currently receiving counseling or medication to quit or reduce smoking
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 |
|---|---|---|
| Cessation counseling with adherence focus | Behavioural | Adherence condition |
| Cessation counseling without adherence focus | Behavioural | Standard condition |
Primary outcome
Continuous abstinence
Time frame: 3 months post-quit date
No smoking from the target quit date through the 3-month follow-up
biochemically-verified 7-day point prevalence abstinence
Time frame: 3 months post-quit date
No smoking in the 7 prior days
1 secondary outcome
Nicotine patch adherence
Time frame: 3 months post-quit date
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 6 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cessation counseling with adherence focus and Cessation counseling without adherence focus in people with Smoking, run by RAND 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 6 inclusion and 3 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 6 Apr 2016. 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?
Continuous abstinence (time frame: 3 months post-quit date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2016; AzTrials last refreshed its copy on 4 Nov 2026.