None listed
Conditions
Interventions
Intervention1: VBA plus Nicotine Replacement therapy (NRT): In trial arm 2 (intervention 1), participants will receive the standard VBA + quit planning as described for the first group, over and above
this will be measured at baseline using the Heaviness of Tobacco use Index.
Intervention2: BISCA: In trial arm 3 (intervention arm 2), an adapted version of a culturally tailored, behavioral intervent
Sponsors
National Institute of Health Research UK
Eligibility
Inclusion criteria
Inclusion criteria: 1. Self-reported daily users of ST products at least for the last 6 months or ST use on >25 days in the past month 2. Able to provide informed consent 3. Motivated and willing to quit ST use within the next 30 days
Exclusion criteria
Exclusion criteria: 1. Self-reported users of any combustible tobacco product (cigarettes, bidis, hookah) or e-cigarettes in the past 30 days or those having Carbon monoxide (CO) levels >10ppm, identified by a breath test. 2. Pregnant or breastfeeding women. 3. Individuals with health conditions, which warrant caution in using NRT and have previously been excluded in trials of nicotine replacement in smoking. These will be assessed by participant self-report at the pre-trial screening by asking participants whether they have suffered angina pectoris, myocardial infarction or stroke the past three weeks. 4. Individuals who are already on an existing treatment, either pharmacological or behavioral, for tobacco cessation. 5. ST using individuals with diagnosis or oral cancer. Due to the nature of care required, any such individuals identified during the recruitment process will receive a direct referral to specialist care for treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessments of: 1. Intervention delivery (quantitative and qualitative) 2. Recruitment, randomisation and retention 3. Data collection and measurement methods Timepoint: 6, 12, 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: 1. Preliminary economic assessment: Change in quality of life and health resource use at 26 weeks 2. Preliminary process evaluation: Identification of implementation feasibility and context, fidelity and mechanisms of impact Timepoint: 6, 12, 26 weeks | — |
Countries
Bangladesh, India, Pakistan
Contacts
Public ContactDr M Meghachandra SIngh
ICMR- National Institute of Cancer Prevention and Research
Outcome results
None listed