Human Immunodeficiency VirusNCT00502827
Smoking Cessation for HIV/AIDS Patients
A study testing Cell Phone Intervention in people with Human Immunodeficiency Virus, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Cell Phone Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to Apr 2015
- 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
- HIV-positive
- 18 years of age or older
- Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
- English or Spanish speaking
- Able to provide written informed consent to participate
- Willing to set a quit date within 1 week of baseline assessment
Who cannot join
- Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
- Current participation in another smoking cessation program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas Street Clinic
Houston, Texas, 77009
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: An Innovative Telephone Intervention for HIV-Positive Smokers
The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.
Read the detailed description
If you agree to take part in this study, researchers will first do a test to learn what the CO level of your blood is. To do this test, you will be asked to blow into a cardboard tube. If the test finds that you are ineligible, you will not be able to continue on this study.
If you are found to be eligible, you will be enrolled in this study and asked to complete an interview that should last about 1 hour. During this interview, you will be asked basic questions, such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and stress. You will then be asked to complete a short test that involves completing some basic tasks, such as remembering several words and drawing a simple shape. This test, which will take about 2-5 minutes to complete, is used to measure attention and concentration.
You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being assigned to either group.
If you are assigned to Group 1, you will receive advice from your physician/provider to stop smoking and written materials designed to help you quit smoking.
If you are assigned to Group 2, you will receive the advice from your physician/provider to quit smoking and the written materials, but you also be given a cell phone and be called 11 times over the course of an 12 to 13 week period. During these calls, which will last about 10 minutes, you will be asked to talk about smoking and quitting smoking. Access to a hotline number that you can call to speak with a counselor about quitting smoking will also be given to you if you are assigned to group 2. Participants in Group 1 will not get the number to the hotline. There is a limited number of prepaid minutes on the phone, so participants who receive a cell phone should make an effort to save enough minutes to complete this study.
You will be asked to complete three more interviews about 3-, 6-, and 12-months after the first interview. During these interviews, you will again be asked questions about your smoking behavior, mood, quality of life, and stress. All three of these interviews will take about one hour to complete. Your participation in this study will be complete after the 12-month interview.
Lost, stolen, or broken cell phones will not be replaced, but participants will remain on study.
This is an investigational study. Up to 705 participants will take part in this research study. All participants will be enrolled at Thomas Street Clinic.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Cell Phone Intervention, Recommended Standard of Care
- Keywords
- Human Immunodeficiency Virus, HIV positive, HIV Positive Smokers, AIDS, Cell Phone Intervention, CPI, Smoking Cessation, Interview
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Seropositivity, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell Phone InterventionBehavioural
Also called CPI
Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking.
Recommended Standard of CareOther
Also called RSOC
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
| Study group | Role | What they receive |
|---|---|---|
| Recommended Standard of Care | Other | Recommended Standard of Care (RSOC) = Physician Advice + Written Materials Receives: Other: Recommended Standard of Care |
| RSOC + Cell Phone Intervention | Other | Recommended Standard of Care (RSOC) + Cell Phone Intervention Receives: Behavioral: Cell Phone Intervention; Other: Recommended Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
Measured: 1 year after quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJan 2004
- Primary completionApr 2015
- Study completionApr 2015
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 Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Damon Vidrine, MS, DRPH, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502827
- Sponsor's protocol ID
- 2003-0784
- Other IDs
- NCI-2012-02109
- Status last verified
- Feb 2016
- First submitted
- 16 Jul 2007
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
PubMed 39101506Buchberg MK, Gritz ER, Kypriotakis G, Arduino RC, Vidrine DJ. The role of BMI change on smoking abstinence in a sample of HIV-infected smokers. AIDS Care. 2016;28(5):603-7. doi: 10.1080/09540121.2015.1120854. Epub 2015 Dec 15.
PubMed 26666313
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Telephone Intervention for HIV-Positive Smokers
- ClinicalTrials.gov ID
- NCT00502827
- Acronym / sponsor ID
- 2003-0784
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, HIV positive, HIV Positive Smokers, AIDS, Cell Phone Intervention, CPI, Smoking Cessation, Interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2004
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 Jul 2007 (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 research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.
Detailed description
If you agree to take part in this study, researchers will first do a test to learn what the CO level of your blood is. To do this test, you will be asked to blow into a cardboard tube. If the test finds that you are ineligible, you will not be able to continue on this study.
If you are found to be eligible, you will be enrolled in this study and asked to complete an interview that should last about 1 hour. During this interview, you will be asked basic questions, such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and stress. You will then be asked to complete a short test that involves completing some basic tasks, such as remembering several words and drawing a simple shape. This test, which will take about 2-5 minutes to complete, is used to measure attention and concentration.
You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being assigned to either group.
If you are assigned to Group 1, you will receive advice from your physician/provider to stop smoking and written materials designed to help you quit smoking.
If you are assigned to Group 2, you will receive the advice from your physician/provider to quit smoking and the written materials, but you also be given a cell phone and be called 11 times over the course of an 12 to 13 week period. During these calls, which will last about 10 minutes, you will be asked to talk about smoking and quitting smoking. Access to a hotline number that you can call to speak with a counselor about quitting smoking will also be given to you if you are assigned to group 2. Participants in Group 1 will not get the number to the hotline. There is a limited number of prepaid minutes on the phone, so participants who receive a cell phone should make an effort to save enough minutes to complete this study.
You will be asked to complete three more interviews about 3-, 6-, and 12-months after the first interview. During these interviews, you will again be asked questions about your smoking behavior, mood, quality of life, and stress. All three of these interviews will take about one hour to complete. Your participation in this study will be complete after the 12-month interview.
Lost, stolen, or broken cell phones will not be replaced, but participants will remain on study.
This is an investigational study. Up to 705 participants will take part in this research study. All participants will be enrolled at Thomas Street Clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recommended Standard of Care | Other | Other: Recommended Standard of CareRecommended Standard of Care (RSOC) = Physician Advice + Written Materials |
| RSOC + Cell Phone Intervention | Other | Behavioral: Cell Phone Intervention, Other: Recommended Standard of CareRecommended Standard of Care (RSOC) + Cell Phone Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-positive
- 18 years of age or older
- Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
- English or Spanish speaking
- Able to provide written informed consent to participate
Key exclusion criteria (2 listed)
- Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
- Current participation in another smoking cessation program
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 |
|---|---|---|
| Cell Phone InterventionAlso: CPIStudy participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking. | Behavioural | RSOC + Cell Phone Intervention |
| Recommended Standard of CareAlso: RSOCAdvice from your physician to stop smoking and written materials designed to help you quit smoking. | Other | RSOC + Cell Phone Intervention, Recommended Standard of Care |
Primary outcome
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
Time frame: 1 year after 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 26 Feb 2016.
- Derived from this study: PubMed 39101506Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
- Derived from this study: PubMed 26666313Buchberg MK, Gritz ER, Kypriotakis G, Arduino RC, Vidrine DJ. The role of BMI change on smoking abstinence in a sample of HIV-infected smokers. AIDS Care. 2016;28(5):603-7. doi: 10.1080/09540121.2015.1120854. Epub 2015 Dec 15.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Damon Vidrine, MS, DRPH, BA principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell Phone Intervention in people with Human Immunodeficiency Virus, run by M.D. Anderson Cancer Center at 2 sites 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 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 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence (time frame: 1 year after quit date). 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 NCT00502827, 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 26 Feb 2016.