At a glance
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A Smoking Cessation Trial in HIV-infected Patients in South Africa
In Brief
A clinical study evaluating Nicotine and Intensive Counseling for Smoking Cessation and HIV. Completed, enrolled 560 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.