Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT05351606
Eligibility Criteria:
Inclusion Criteria:
* Human immunodeficiency virus (HIV)-seropositive,
* Age \>=18 years
* Currently taking or initiating antiretroviral therapy (ART)
* Access to mobile phone for phone or text follow up visit (intensive intervention only)
* Able to read or be read short message service (SMS) messages (intensive intervention only).
Tobacco inclusion criteria:
* Current tobacco users, who have used tobacco in the past 7 days;
* Must have smoked at least 100 cigarettes in lifetime, and at least 5 cigarettes per day biochemically verified by expired Carbon Monoxide (CO) \>= 5-6 parts per million (ppm).
Exclusion Criteria:
* Advanced HIV disease, age \< 18 years
* Unable to provide verbal informed consent
* Unwilling to be contacted by clinic for follow up
Additional exclusion criteria in the intensive intervention group:
* Myocardial Infarction (MI) in the 2 weeks prior to signing consent
* Pregnant (NRT and Bupropion may be contraindicated).
* Patients for whom Bupropion is contraindicated (e.g. history of seizures, recent use of Monoamine oxidase (MAO) inhibitors, breastfeeding, and whose ART protocol present, as per prescription guidance, contraindications).
* Prior disclosure of HIV status to the phone owner for those who use phones will be required to prevent inadvertent disclosure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05351606
Study Brief:
Protocol Section:
NCT05351606