N/A
Completed N=560
A Smoking Cessation Trial in HIV-infected Patients in South Africa
Source: ClinicalTrials.gov NCT01484340 ↗Enrolled (actual)
560
Serious AEs
1.6%
Results posted
Nov 2018
Primary outcomePrimary: Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) — 11; 11 COppm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) |
11; 11 | — |
| PRIMARY Smoking Status Using a Point of Care Test for Measuring Cotinine |
1.7; 1.5 | — |
| SECONDARY Smoking Status (COppm) |
10; 10 | — |
| SECONDARY Smoking Status (COppm) |
10; 10 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01484340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.