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

NCT01484340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2019-10-04

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • Truth Initiative

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Jonathan Golub, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-28
Primary Completion
2016-06-30
Completion
2017-06-30

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01484340 on ClinicalTrials.gov