Smoking CessationJHUNCT01484340
A Smoking Cessation Trial in HIV-infected Patients in South Africa
A study testing Nicotine and Intensive Counseling in people with Smoking Cessation and HIV, run by Johns Hopkins University at 3 sites in South Africa.
Trial summary
The purpose of this study is to conduct a randomized controlled trial (RCT) of intensive anti-smoking counseling plus nicotine replacement therapy versus intensive anti-smoking counseling alone among HIV-infected patients in South Africa, and to concurrently measure the prevalence of smoking among HIV-infected… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, HIV
- What is being tested?
- Nicotine and Intensive Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 28 Mar 2014to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Current, daily smoker (biochemically verified via a positive result on the SmokeScreen® test from GFC Diagnostics Ltd., as described in the outcomes)
- Be willing to set a quit date within 2 weeks after baseline assessment
- Agree to participate in study and anticipated to be attending Tshepong Wellness Clinic, Jouberton Community Health Center, or Grace Mokhomo Community Health Center (due to HIV infection) for at least 6 months
Who cannot join
- Pregnant or nursing
- Currently using smokeless tobacco (including electronic cigarettes, NRT or other cessation treatment)
- Tuberculosis confirmed case
- Weight <45 kg or BMI <20
- Suffering from any unstable medical condition which could preclude use of the nicotine patch:
- unstable angina
Show all 9Show fewer
- uncontrolled hypertension
- active skin disease (e.g. psoriasis)
- history of skin allergy
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Grace Mokhomo Community Health Center
Klerksdorp, North West
Jouberton Community Health Center
Klerksdorp, North West
Tshepong Wellness Clinic
Klerksdorp, North West
About this study
The purpose of this study is to conduct a randomized controlled trial (RCT) of intensive anti-smoking counseling plus nicotine replacement therapy versus intensive anti-smoking counseling alone among HIV-infected patients in South Africa, and to concurrently measure the prevalence of smoking among HIV-infected patients in South Africa.
Read the detailed description
Tobacco use is estimated to be responsible for over 5 million deaths globally every year and HIV/AIDS kills 2 million worldwide, with persons living in the developing world especially at risk. However, the association between tobacco use and HIV is not clearly understood. The introduction of highly active antiretroviral therapy (HAART) has led to longer duration of survival following HIV-infection in the developed world, and now that HAART is being rolled out in the developing world, survival will increase in these highly endemic regions as well. Given this increase in survival, more people will die of non-HIV related illnesses for which smoking plays an important causal role. Smoking cessation for HIV-infected persons has been studied in the US though these studies have had small numbers and limited follow-up. US based studies suggest that approaches that combine nicotine replacement therapy (NRT) and counseling interventions are most successful. Optimal approaches in resource-limited settings have not been determined.
This study will compare intensive counseling plus NRT versus intensive counseling only, comparing smoking cessation at 2, 6 and 12 months. At 6 months, patients who are still current smokers will be given a second opportunity to receive their group assigned intervention, either intensive counseling plus NRT or intensive counseling alone. We will relate smoking exposure and cessation to HIV progression as measured by immunologic and viral markers, risk of respiratory infections, including tuberculosis, and AIDS-related malignancies. The RCT will be performed at the Tshepong HIV Wellness Clinic in Klerksdorp, South Africa, associated with the Reproductive Health \& HIV Research Unit of the University of the Witwatersrand, South Africa.
- Conditions
- Smoking Cessation, HIV
- Being tested
- Nicotine, Intensive Counseling
- Keywords
- smoking, administration, cutaneous
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called Nicorette
The nicotine patch be given in three phases:
- 2 weeks of patches at enrollment
- 6 weeks of patches at two-week follow-up visit
- 2 weeks of patches at two-month follow-up visit
This schedule will cover the entire 10-week course of therapy as per label instructions: 6 weeks at 21mg; 2 weeks at 14mg; and 2 weeks at 7mg.
Intensive CounselingBehavioural
The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
Visit schedule:
- Baseline
- 2-week follow-up (Quit Day)
- 1-month follow-up
- 2-month follow-up
- 3-month follow-up
- 6-month follow-up
Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
Participants still smoking at 6-month follow-up will be offered group-assigned intervention again.
| Study group | Role | What they receive |
|---|---|---|
| Counseling only | Experimental | Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling). Receives: Behavioral: Intensive Counseling |
| Nicotine Replacement Therapy +counseling | Experimental | Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches). Receives: Drug: Nicotine; Behavioral: Intensive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.
Measured: 6 months from baseline
Smoking Status Using a Point of Care Test for Measuring Cotinine
A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A reading of < 0.4 μg/ml cotinine equivalent will indicate abstinence.
Measured: 6 months from baseline
Secondary outcomes (2)
Smoking Status (COppm)
A point of care test for measuring CO will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.
Measured: 2 months from baseline
Smoking Status (COppm)
A point of care test for measuring CO will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study start28 Mar 2014
- Primary completion30 Jun 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Witwatersrand, South Africa, Truth Initiative
- Responsible party
- Sponsor
- Investigators
- Jonathan Golub, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484340
- Sponsor's protocol ID
- NA_00048461
- Other IDs
- 1R01DA030276-01A1
- Acronym
- JHU
- Status last verified
- Oct 2019
- First submitted
- 30 Nov 2011
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smoking Cessation Trial in HIV-infected Patients in South Africa
- ClinicalTrials.gov ID
- NCT01484340
- Acronym / sponsor ID
- JHU / NA_00048461
- Conditions
- Smoking Cessation, HIV
- Keywords
- smoking, administration, cutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Witwatersrand, South Africa, Truth Initiative
- Study start
- 28 Mar 2014 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 6 Nov 2018
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 conduct a randomized controlled trial (RCT) of intensive anti-smoking counseling plus nicotine replacement therapy versus intensive anti-smoking counseling alone among HIV-infected patients in South Africa, and to concurrently measure the prevalence of smoking among HIV-infected patients in South Africa.
Detailed description
Tobacco use is estimated to be responsible for over 5 million deaths globally every year and HIV/AIDS kills 2 million worldwide, with persons living in the developing world especially at risk. However, the association between tobacco use and HIV is not clearly understood. The introduction of highly active antiretroviral therapy (HAART) has led to longer duration of survival following HIV-infection in the developed world, and now that HAART is being rolled out in the developing world, survival will increase in these highly endemic regions as well. Given this increase in survival, more people will die of non-HIV related illnesses for which smoking plays an important causal role. Smoking cessation for HIV-infected persons has been studied in the US though these studies have had small numbers and limited follow-up. US based studies suggest that approaches that combine nicotine replacement therapy (NRT) and counseling interventions are most successful. Optimal approaches in resource-limited settings have not been determined.
This study will compare intensive counseling plus NRT versus intensive counseling only, comparing smoking cessation at 2, 6 and 12 months. At 6 months, patients who are still current smokers will be given a second opportunity to receive their group assigned intervention, either intensive counseling plus NRT or intensive counseling alone. We will relate smoking exposure and cessation to HIV progression as measured by immunologic and viral markers, risk of respiratory infections, including tuberculosis, and AIDS-related malignancies. The RCT will be performed at the Tshepong HIV Wellness Clinic in Klerksdorp, South Africa, associated with the Reproductive Health \& HIV Research Unit of the University of the Witwatersrand, South Africa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling only | Experimental | Behavioral: Intensive CounselingParticipants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling). |
| Nicotine Replacement Therapy +counseling | Experimental | Drug: Nicotine, Behavioral: Intensive CounselingParticipants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current, daily smoker (biochemically verified via a positive result on the SmokeScreen® test from GFC Diagnostics Ltd., as described in the outcomes)
- Be willing to set a quit date within 2 weeks after baseline assessment
- Agree to participate in study and anticipated to be attending Tshepong Wellness Clinic, Jouberton Community Health Center, or Grace Mokhomo Community Health Center (due to HIV infection) for at least 6 months
Key exclusion criteria (9 listed)
- Pregnant or nursing
- Currently using smokeless tobacco (including electronic cigarettes, NRT or other cessation treatment)
- Tuberculosis confirmed case
- Weight <45 kg or BMI <20
- Suffering from any unstable medical condition which could preclude use of the nicotine patch:
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 |
|---|---|---|
| NicotineAlso: NicoretteThe nicotine patch be given in three phases: * 2 weeks of patches at enrollment * 6 weeks of patches at two-week follow-up visit * 2 weeks of patches at two-month follow-up visit This schedule will cover the entire 10-week course of therapy as per label instructions: 6 weeks at 21mg; 2 weeks at 14mg; and 2 weeks at 7mg. | Drug | Nicotine Replacement Therapy +counseling |
| Intensive CounselingThe advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. Visit schedule: * Baseline * 2-week follow-up (Quit Day) * 1-month follow-up * 2-month follow-up * 3-month follow-up * 6-month follow-up Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up. Participants still smoking at 6-month follow-up will be offered group-assigned intervention again. | Behavioural | Counseling only, Nicotine Replacement Therapy +counseling |
Primary outcome
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
Time frame: 6 months from baseline
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.
Smoking Status Using a Point of Care Test for Measuring Cotinine
Time frame: 6 months from baseline
A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A reading of < 0.4 μg/ml cotinine equivalent will indicate abstinence.
2 secondary outcomes
Smoking Status (COppm)
Time frame: 2 months from baseline
Smoking Status (COppm)
Time frame: 12 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Golub, PhD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine and Intensive Counseling in people with Smoking Cessation and HIV, run by Johns Hopkins University at 3 sites in South Africa.
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 9 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 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) (time frame: 6 months from baseline). 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 4 Oct 2019.