Clinical trial NCT01484340: A Smoking Cessation Trial in HIV-infected Patients in South Africa
Official title: A Smoking Cessation Trial in HIV-infected Patients in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
HIV
Keywords: smoking
administration, cutaneous
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Witwatersrand, South Africa
name: Truth Initiative
First posted: 2011-12-02
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
timeFrame: 6 months from baseline
measure: Smoking Status Using a Point of Care Test for Measuring Cotinine
timeFrame: 6 months from baseline
Secondary outcomes:
measure: Smoking Status (COppm)
timeFrame: 2 months from baseline
measure: Smoking Status (COppm)
timeFrame: 12 months from baseline
Other outcomes:
Locations:
city: Klerksdorp
country: South Africa
facility: Grace Mokhomo Community Health Center
state: North West
city: Klerksdorp
country: South Africa
facility: Jouberton Community Health Center
state: North West
city: Klerksdorp
country: South Africa
facility: Tshepong Wellness Clinic
state: North West
Study officials:
affiliation: Johns Hopkins University
name: Jonathan Golub, PhD
role: PRINCIPAL_INVESTIGATOR
References: