Status:
COMPLETED
A Smoking Cessation Trial in HIV-infected Patients in South Africa
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
University of Witwatersrand, South Africa
Conditions:
Smoking Cessation
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT01484340
Start Date
March 28 2014
End Date
June 30 2017
Last Update
October 4 2019
Active Locations (3)
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1
Grace Mokhomo Community Health Center
Klerksdorp, North West, South Africa
2
Jouberton Community Health Center
Klerksdorp, North West, South Africa
3
Tshepong Wellness Clinic
Klerksdorp, North West, South Africa