- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01484340
A Smoking Cessation Trial in HIV-infected Patients in South Africa (JHU)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North West
-
Klerksdorp, North West, South Africa
- Grace Mokhomo Community Health Center
-
Klerksdorp, North West, South Africa
- Jouberton Community Health Center
-
Klerksdorp, North West, South Africa
- Tshepong Wellness Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- uncontrolled hypertension
- active skin disease (e.g. psoriasis)
- history of skin allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Counseling only
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).
|
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:
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. |
Experimental: Nicotine Replacement Therapy +counseling
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).
|
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:
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. The nicotine patch be given in three phases:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months from baseline
|
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.
|
6 months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Status (COppm)
Time Frame: 2 months from baseline
|
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.
|
2 months from baseline
|
Smoking Status (COppm)
Time Frame: 12 months from baseline
|
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.
|
12 months from baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Golub, PhD, Johns Hopkins University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00048461
- 1R01DA030276-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
The University of Hong KongNot yet recruitingSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
Clinical Trials on Intensive Counseling
-
Soroka University Medical CenterUnknown
-
IRCCS Policlinico S. MatteoRecruitingNutritional SupportItaly
-
Meir Medical CenterClalit Health ServicesUnknownPrediabetes | Young Adults | Community Health Services | Ethnic GroupIsrael
-
Ege UniversityCompletedMalnutrition | Stroke, Acute | Old Age; DebilityTurkey
-
Örebro County CouncilCompleted
-
University of OuluActive, not recruiting
-
International Centre for Diarrhoeal Disease Research...Obstetrical and Gynaecological Society of Bangladesh (OGSB)Active, not recruiting
-
US Department of Veterans AffairsUniversity of California, San Diego; California Smokers' HelplineCompleted
-
University of Sao Paulo General HospitalUnknownHead and Neck NeoplasmsBrazil
-
Amy E RothbergUniversity of MichiganCompletedObese | Subfertility | AnovulatoryUnited States