A Smoking Cessation Trial in HIV-infected Patients in South Africa

Not Applicable

Completed

Conditions: Smoking Cessation
HIV

Interventions: Behavioral: Intensive Counseling
Drug: Nicotine

Registration Number: NCT01484340

Lead Sponsor: Johns Hopkins University

Brief 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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 560

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counseling only	Intensive Counseling	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).
Nicotine Replacement Therapy +counseling	Intensive 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).
Nicotine Replacement Therapy +counseling	Nicotine	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).

Primary Outcome Measures

Name	Time	Method
Smoking Status Using a Point of Care Test for Measuring Cotinine	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.
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)	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.

Secondary Outcome Measures

Name	Time	Method
Smoking Status (COppm)	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.

Trial Locations

Locations (3): Grace Mokhomo Community Health Center
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Klerksdorp, North West, South Africa
Tshepong Wellness Clinic
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Klerksdorp, North West, South Africa
Jouberton Community Health Center
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Klerksdorp, North West, South Africa