Smokeless Tobacco control research in in South Asia

Not Applicable

Registration Number: CTRI/2019/01/016899

Lead Sponsor: ational Institute of Health Research UK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility assessments of: <br/ ><br>1.Intervention delivery (quantitative and qualitative) <br/ ><br>2.Recruitment, randomisation and retention <br/ ><br>3.Data collection and measurement methods <br/ ><br>Timepoint: 6, 12, 26 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary: <br/ ><br>1.Preliminary economic assessment: Change in quality of life and health resource use at 26 weeks <br/ ><br>2.Preliminary process evaluation: Identification of implementation feasibility and context, fidelity and mechanisms of impact <br/ ><br>Timepoint: 6, 12, 26 weeks