Evaluating Smoking Cessation Interventions for PWH in South Africa
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
The overall objective of the study is to optimize a smoking cessation treatment package for people with HIV (PWH) that can be integrated into existing HIV care in South Africa.
Eligibility criteria
Qualifiers
≥18 years of age, and
attend one of the selected study clinics, and
have a confirmed diagnosis of HIV (evidenced by one of: clinic or hospital prescription for combination antiretroviral therapy (ART), or a current ART medication pack that has the patient's name documented thereon) and
have been taking ART for at least three consecutive months or evidence of taking ART for four of the past six months (to ensure engagement in care at the recruitment clinic), and
Disqualifiers
Currently (within the previous 14 days) receiving or using smoking cessation counselling or pharmacotherapy, or
are unable to participate due to severity of medical illness, guided by a Karnofsky score of ≤ 40, or
have a history of seizures, cancer, heart disease, stroke, myocardial infarction, stomach ulcers, kidney failure, or liver failure, or
have generalized eczema or psoriasis, or
Trial design
Treatments tested in this trial
- Varenicline
- Nicotine patch
- Nicotine gum
- Intensive Behavioral Counselling
- Peer Counselling
Treatment groups
660 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Johns Hopkins University
Lead sponsor
Colorado State University
Collaborator
New York University
Collaborator
Perinatal HIV Research Unit of the University of the Witswatersrand
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov