| CTRI Number |
CTRI/2019/01/016899 [Registered on: 04/01/2019] Trial Registered Prospectively |
| Last Modified On: |
19/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Smokeless Tobacco control research in in South Asia |
|
Scientific Title of Study
|
Addressing Smokeless Tobacco and building Research Capacity in South Asia |
| Trial Acronym |
ASTRA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Ravi Mehrotra |
| Designation |
Director |
| Affiliation |
ICMR- National Institute of Cancer Prevention and Research |
| Address |
ICMR-NICPR, I-7, Sector 39, NOIDA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
01202446900 |
| Fax |
|
| Email |
directornicpr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Kaushik |
| Designation |
Scientist C |
| Affiliation |
ICMR- National Institute of Cancer Prevention and Research |
| Address |
ICMR-NICPR, I-7, Sector 39, NOIDA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
01202446921 |
| Fax |
|
| Email |
rkaushikicmr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Meghachandra SIngh |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of PSM, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
megharita1@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Health Research UK |
|
|
Primary Sponsor
|
| Name |
National Institute of Health Research UK |
| Address |
NIHR London United Kingdom |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh
India
Pakistan |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Ravi Mehrotra |
ICMR-National Institute of Cancer Prevention and Research |
Room no. 16, Division of Preventive Oncology, ICMR-NICPR, I-39, Sector 39, NOIDA
Gautam Buddha Nagar
UTTAR PRADESH |
01202446900
director.nicpr@gmail.com |
| Prof Suneela Garg |
Maulana Azad Medical College |
Room number 359, Department of Community Medicine, MAMC. 2, Bahadur Shah Jafar Marg, New Delhi-110002
Central
DELHI |
9810043707
gargsuneela@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ICMR- NICPR Institutional Ethics Committee |
Approved |
| Insitutional Ethics Committee Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Smokeless Tobacco Users and Sellers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BISCA |
In trial arm 3 (intervention arm 2), an adapted version of a culturally tailored, behavioral intervention for South Asian adults (BISCA) to quit Smokeless Tobacco. The BISCA intervention contains a set of 23 activities organised into pre-quit, quit and post-quit sessions |
| Intervention |
BISCA plus NRT |
Trial arm 4 (intervention arm 3), participants will receive a combination of both BISCA and NRT. The NRT will be provided to participants from their quit date onwards, for a total 8-week duration. |
| Intervention |
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 which they will receive oral nicotine gum from their randomization date, for a total duration of 8 weeks. Locally available nicotine gum will be used. Participants randomised to this trial arm will receive varying doses of nicotine gum based on their level of dependence; this will be measured at baseline using the Heaviness of Tobacco use Index. |
| Comparator Agent |
Very Brief Advice (VBA) |
Participants randomized to trial arm 1 (control arm) will receive VBA adapted from a community-based trial of tobacco cessation in India. As part of VBA, participants will receive verbal information on the harmful effects of tobacco. Participants will be advised to set a quit date and stop tobacco use. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Feasibility assessments of:
1. Intervention delivery (quantitative and qualitative)
2. Recruitment, randomisation and retention
3. Data collection and measurement methods
|
6, 12, 26 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
6, 12, 26 weeks |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Addressing smokeless tobacco (ST) research and capacity building in South Asia is an NIHR, UK funded project having four arms. This project is a collaborative effort of 5 UK Universities and few institutes in India, Bangladesh, and Pakistan. Two of the arms are being conducted in India. The coordinating centers in India being ICMR-National Institute of Cancer Prevention and Research and Maulana Azad Medical College, New Delhi. The study is conducted under two arms/heads in India
1. Cessation 2. Sellers The study would be done in both Urban and rural communities settings.
|