Overview

This trial is active, not recruiting.

Conditions smoking cessation, hiv
Treatments nicotine, intensive counseling
Sponsor Johns Hopkins University
Collaborator National Institute on Drug Abuse (NIDA)
Start date March 2014
End date June 2016
Trial size 500 participants
Trial identifier NCT01484340, 1R01DA030276-01A1, 4134401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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).
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: 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.
(Experimental)
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 Nicorette
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.
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: 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.

Primary Outcomes

Measure
Smoking status
time frame: 6 months from baseline

Secondary Outcomes

Measure
Smoking status
time frame: 2 months from baseline and 12 months from baseline
Urges to smoke
time frame: Baseline, 2-week visit, 2-month visit, 6-month visit, and 12-month visit
Withdrawal symptoms
time frame: Baseline, 2-week visit, 2-month visit, 6-month visit, and 12-month visit
Reinforcing effects of smoking
time frame: Baseline, 2-week visit, 2-month visit, 6-month visit, and 12-month visit

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Smoking Cessation Trial in HIV-infected Patients in South Africa
Principal investigator Jonathan Golub, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.