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

NCT01484340 | Completed Results DMC

• 2 other identifiers: NA_000484611R01DA030276-01A1
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 3

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.

Conditions

Smoking Cessation; HIV

Keywords

smoking; administration, cutaneous

Outcome Measures

Primary Outcomes (2)

• Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)

  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.

  6 months from baseline

• Smoking Status Using a Point of Care Test for Measuring Cotinine

  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.

  6 months from baseline

Secondary Outcomes (2)

• Smoking Status (COppm)

  2 months from baseline

• Smoking Status (COppm)

  12 months from baseline

Study Arms (2)

Counseling only

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).

Behavioral: Intensive Counseling

Nicotine Replacement Therapy +counseling

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).

Drug: Nicotine; Behavioral: Intensive Counseling

Interventions

Nicotine DRUG

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.

Also known as: Nicorette

Nicotine Replacement Therapy +counseling

Intensive Counseling BEHAVIORAL

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.

Counseling only; Nicotine Replacement Therapy +counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Witwatersrand, South Africa: collaborator
• Truth Initiative: collaborator

Study Sites (3)

Grace Mokhomo Community Health Center

Klerksdorp, North West, South Africa

Location

Jouberton Community Health Center

Klerksdorp, North West, South Africa

Location

Tshepong Wellness Clinic

Klerksdorp, North West, South Africa

Location

Related Links

• 5 As: Treating Tobacco Use and Dependence

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Nicotine; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Jonathan E. Golub
• Organization: Johns Hopkins University School of Medicine

jgolub@jhmi.edu

443-287-2969

Study Officials

• Jonathan Golub, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: March 28, 2014
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2017
• Last Updated: October 4, 2019
• Results First Posted: November 6, 2018

Record last verified: 2019-10

Locations

ZA (3)