SmokingPhase 3NCT01106638
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
A Phase 3 study testing Positively Smoke Free in people with Smoking and HIV Infections, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, HIV Infections, AIDS
- What is being tested?
- Positively Smoke Free
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Apr 2011
- Phase
- Phase 3
- 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
- HIV-infection
- current cigarette smoker
- high motivation to quit
Who cannot join
- Pregnancy
- breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.
- Conditions
- Smoking, HIV Infections, AIDS
- Being tested
- Positively Smoke Free, Standard care
- Keywords
- HIV, AIDS, Smoking, Tobacco, Cessation, Tobacco use in persons living with HIV/AIDS
- Medical subject headings
- Smoking, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positively Smoke FreeBehavioural
An eight session, group therapy intervention targeting smokers living with HIV/AIDS
Standard careBehavioural
Advice to quit, smoking cessation brochure, and offer of nicotine patches
| Study group | Role | What they receive |
|---|---|---|
| Intensive behavioral intervention | Experimental | Eight session, behavioral intervention targeting HIV-infected smokers Receives: Behavioral: Positively Smoke Free |
| Standard care | Active comparator | Advice to quit, smoking cessation brochure, offer of nicotine patch Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three month point-prevalence abstinence from cigarettes
Measured: 3 months post-intervention
Secondary outcomes (1)
Three month continuous abstinence from cigarettes
Measured: Three months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Yale University
- Responsible party
- Principal investigator, Jonathan Shuter, Montefiore Medical Center
- Investigators
- Jonathan Shuter, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106638
- Sponsor's protocol ID
- R21DA023362
- Status last verified
- Apr 2018
- First submitted
- 19 Apr 2010
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Shuter J, Pearlman BK, Stanton CA, Moadel AB, Kim RS, Weinberger AH. Gender Differences among Smokers Living with HIV. J Int Assoc Provid AIDS Care. 2016 Sep;15(5):412-7. doi: 10.1177/2325957416649439. Epub 2016 May 23.
PubMed 27215559Moadel AB, Bernstein SL, Mermelstein RJ, Arnsten JH, Dolce EH, Shuter J. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):208-15. doi: 10.1097/QAI.0b013e3182645679.
PubMed 22732470
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
- ClinicalTrials.gov ID
- NCT01106638
- Acronym / sponsor ID
- R21DA023362
- Conditions
- Smoking, HIV Infections, AIDS
- Keywords
- HIV, AIDS, Smoking, Tobacco, Cessation, Tobacco use in persons living with HIV/AIDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Yale University
- Study start
- Dec 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Apr 2010 (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 purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive behavioral intervention | Experimental | Behavioral: Positively Smoke FreeEight session, behavioral intervention targeting HIV-infected smokers |
| Standard care | Active comparator | Behavioral: Standard careAdvice to quit, smoking cessation brochure, offer of nicotine patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infection
- current cigarette smoker
- high motivation to quit
Key exclusion criteria (2 listed)
- Pregnancy
- breastfeeding
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 |
|---|---|---|
| Positively Smoke FreeAn eight session, group therapy intervention targeting smokers living with HIV/AIDS | Behavioural | Intensive behavioral intervention |
| Standard careAdvice to quit, smoking cessation brochure, and offer of nicotine patches | Behavioural | Standard care |
Primary outcome
Three month point-prevalence abstinence from cigarettes
Time frame: 3 months post-intervention
1 secondary outcome
Three month continuous abstinence from cigarettes
Time frame: Three months post-intervention
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 27 Apr 2018.
- Derived from this study: PubMed 27215559Shuter J, Pearlman BK, Stanton CA, Moadel AB, Kim RS, Weinberger AH. Gender Differences among Smokers Living with HIV. J Int Assoc Provid AIDS Care. 2016 Sep;15(5):412-7. doi: 10.1177/2325957416649439. Epub 2016 May 23.
- Derived from this study: PubMed 22732470Moadel AB, Bernstein SL, Mermelstein RJ, Arnsten JH, Dolce EH, Shuter J. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):208-15. doi: 10.1097/QAI.0b013e3182645679.
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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.
Jonathan Shuter, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Positively Smoke Free in people with Smoking and HIV Infections, run by Montefiore Medical Center 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 3 inclusion and 2 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 27 Apr 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Three month point-prevalence abstinence from cigarettes (time frame: 3 months post-intervention). 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 NCT01106638, which also lists 2 linked publications.
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 27 Apr 2018.