A Smoking Cessation Trial in HIV-infected Patients in South Africa (JHU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Johns Hopkins University
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
American Legacy Foundation
Information provided by (Responsible Party):
Jonathan E Golub, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01484340
First received: November 30, 2011
Last updated: July 22, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Smoking Cessation
HIV
Drug: Nicotine
Behavioral: Intensive Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Smoking Cessation Trial in HIV-infected Patients in South Africa

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Smoking status [ Time Frame: 6 months from baseline ] [ Designated as safety issue: No ]
    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. 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.


Secondary Outcome Measures:
  • Smoking status [ Time Frame: 2 months from baseline and 12 months from baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    Smoking Urge Questionnaire

    This scale consists of five items:

    1. "I have a desire for a cigarette right now"
    2. "If it were possible I would smoke now"
    3. "All I want right now is a cigarette"
    4. "I have an urge for a cigarette"
    5. "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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    Cigarette Evaluation Questionnaire

    The scale yields 3 subscales:

    1. Smoking Satisfaction (satisfying, taste good, enjoy smoking)
    2. Psychological Reward (calm down, more awake, less irritable, help concentrate, reduce hunger)
    3. Aversion (dizziness, nauseous).


Estimated Enrollment: 500
Study Start Date: March 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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:

  • 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: 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).
Drug: Nicotine

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.

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:

  • 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484340

Contacts
Contact: Sandy Chon, MHS 410-955-2886 schon2@jhmi.edu

Locations
South Africa
Tshepong Wellness Clinic Recruiting
Klerksdorp, North West, South Africa
Principal Investigator: Neil Martinson, MBBCh         
Jouberton Community Health Center Not yet recruiting
Klerksdorp, North West, South Africa
Principal Investigator: Neil Martinson, MBBCh         
Grace Mokhomo Community Health Center Not yet recruiting
Klerksdorp, North West, South Africa
Principal Investigator: Neil Martinson, MBBCh         
Sponsors and Collaborators
Johns Hopkins University
University of Witwatersrand, South Africa
American Legacy Foundation
Investigators
Principal Investigator: Jonathan Golub, PhD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Jonathan E Golub, Associate Professor, Medicine, Epidemiology & International Health, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01484340     History of Changes
Other Study ID Numbers: 4134401, 1R01DA030276-01A1
Study First Received: November 30, 2011
Last Updated: July 22, 2014
Health Authority: South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
smoking
administration, cutaneous

Additional relevant MeSH terms:
Smoking
Food Habits
Habits
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014