A Smoking Cessation Trial in HIV-infected Patients in South Africa (JHU)
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ClinicalTrials.gov Identifier: NCT01484340 |
Recruitment Status
:
Completed
First Posted
: December 2, 2011
Last Update Posted
: December 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Smoking Cessation HIV | Drug: Nicotine Behavioral: Intensive Counseling | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 561 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Smoking Cessation Trial in HIV-infected Patients in South Africa |
Actual Study Start Date : | March 28, 2014 |
Actual Primary Completion Date : | June 30, 2016 |
Actual Study Completion Date : | June 30, 2017 |
Arm | Intervention/treatment |
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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).
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Behavioral: Intensive 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).
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Drug: Nicotine
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 Name: Nicorette
Behavioral: Intensive 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. |
- 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 ≤ 8ppm 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 color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.
- Smoking status [ Time Frame: 2 months from baseline and 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 ≤ 8ppm will indicate abstinence. 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 color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.
- Urges to smoke [ Time Frame: Baseline, 2-week visit, 2-month visit, 6-month visit, and 12-month visit ]
Smoking Urge Questionnaire
This scale consists of five items:
- "I have a desire for a cigarette right now"
- "If it were possible I would smoke now"
- "All I want right now is a cigarette"
- "I have an urge for a cigarette"
- "I crave a cigarette right now"
Responses to each item are rated from 0 (not at all) to 100 (the strongest feeling possible); responses are averaged to produce a craving intensity score.
- Withdrawal symptoms [ Time Frame: Baseline, 2-week visit, 2-month visit, 6-month visit, and 12-month visit ]
Wisconsin Smoking Withdrawal Scale
The 28-item scale contains 7 reliable subscales tapping the major symptom elements of nicotine withdrawal syndrome (Anger, Anxiety, Concentration, Sadness, Hunger, Sleep, Craving). Cronbach's alpha for the subscales ranges from .75 to .93. The scale is sensitive to smoking withdrawal, and is predictive of smoking cessation outcomes.
- Reinforcing effects of smoking [ Time Frame: Baseline, 2-week visit, 2-month visit, 6-month visit, and 12-month visit ]
Cigarette Evaluation Questionnaire
The scale yields 3 subscales:
- Smoking Satisfaction (satisfying, taste good, enjoy smoking)
- Psychological Reward (calm down, more awake, less irritable, help concentrate, reduce hunger)
- Aversion (dizziness, nauseous).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484340
South Africa | |
Grace Mokhomo Community Health Center | |
Klerksdorp, North West, South Africa | |
Jouberton Community Health Center | |
Klerksdorp, North West, South Africa | |
Tshepong Wellness Clinic | |
Klerksdorp, North West, South Africa |
Principal Investigator: | Jonathan Golub, PhD | Johns Hopkins University |
Additional Information:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01484340 History of Changes |
Other Study ID Numbers: |
NA_00048461 1R01DA030276-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | December 2, 2011 Key Record Dates |
Last Update Posted: | December 26, 2017 |
Last Verified: | December 2017 |
Keywords provided by Johns Hopkins University:
smoking administration, cutaneous |
Additional relevant MeSH terms:
Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |