FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050240 [Registered on: 02/03/2023] Trial Registered Prospectively
Last Modified On: 28/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to provide Varenicline and mobile behavioral assistance for quitting tobacco in HIV positive individuals in India 
Scientific Title of Study   Varenicline and mobile behavioral assistance for tobacco cessation in HIV care in India 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNKumarasamy 
Designation  Chief and Director 
Affiliation  VHS Infectious Diseases Medical Centre, CART Clinical Research Site 
Address  VHS Infectious Diseases Medical Centre, CART Clinical Research Site, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai - 600113
VHS Infectious Diseases Medical Centre, CART Clinical Research Site, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai - 600113
Chennai
TAMIL NADU
600113
India 
Phone  09176912007  
Fax  04471226814  
Email  kumarasamy@cartcrs.org  
 
Details of Contact Person
Scientific Query  
Name  Poongulali Selvamuthu 
Designation  Principal Investigator 
Affiliation  VHS Infectious Diseases Medical Centre, CART Clinical Research Site 
Address  VHS Infectious Diseases Medical Centre, CART Clinical Research Site, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai - 600113
Infectious Diseases Medical Center Voluntary Health Services Rajiv Gandhi Salai
Chennai
TAMIL NADU
600113
India 
Phone  09940560019  
Fax  04471226814  
Email  poongulali@cartcrs.org  
 
Details of Contact Person
Public Query  
Name  Poongulali Selvamuthu 
Designation  Principal Investigator 
Affiliation  VHS Infectious Diseases Medical Centre, CART Clinical Research Site 
Address  VHS Infectious Diseases Medical Centre, CART Clinical Research Site, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai - 600113
Infectious Diseases Medical Center Voluntary Health Services Rajiv Gandhi Salai
Chennai
TAMIL NADU
600113
India 
Phone  09940560019  
Fax  04471226814  
Email  poongulali@cartcrs.org  
 
Source of Monetary or Material Support  
National Cancer Institute, National Institute of Health, USA 
 
Primary Sponsor  
Name  National Cancer Institute 
Address  National Cancer Institute, National Institute of Health, Bethesda, Maryland, 20814 USA 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Faith Beulah   Voluntary Health Services  VHS Infectious Diseases Medical Centre, CART Clinical Research Site, First Floor, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai -600113
Chennai
TAMIL NADU 		 919962081313

beulah@cartcrs.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, The Voluntary Health Services  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of care with counseling and referral to National tobacco quitline   regular counseling in the clinic with referral to the quitline  
Intervention  Varenicline and Positively smoke free Mobile App  Varenicline is a FDA approved drug for tobacco cessation Positively smoke free is a mobile app tailored to assist tobacco cessation Varenicline 0.5mg OD (Day 1-3), 0.5mg BD (Day 4-7), 1mg (Day 8- Week12) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  HIV positive
willing to participate in the study 
 
ExclusionCriteria 
Details  1.Past 30-day use of tobacco cessation pharmacotherapy or behavioral treatments
2.Pregnant or planning to become pregnant in the next 6 months
3.Breastfeeding
4.Myocardial infarction in past 30 days or unstable angina
5.History of liver or kidney failure
6.ALT and AST > 2 times ULN or creatinine clearance <50 in past 6 months
7.History of suicide attempt
8.Current suicidal ideation53
9.Untreated or unstable major depressive disorder
10.History of psychosis or on anti-psychotic medications
11.Cognitive impairment limiting ability to consent
12.Allergy to varenicline
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Biochemically validated 7-day point prevalent abstinence (PPA) at 6-months  4 Weeks, 12 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
process outcomes and an adaptation of the framework for digital health interventions81,82 we will examine acceptability, adoption, appropriateness, feasibility, fidelity, cost, reach also called penetration, and sustainability   24 weeks 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   14/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/03/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [poongulali@cartcrs.org].

  6. For how long will this data be available start date provided 17-12-2022 and end date provided 17-12-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This project proposes an open label, randomized controlled trial of 400 persons living with HIV who smoke or use smoked and smokeless tobacco and are in care for HIV in Chennai. Participants will be followed over 24 weeks. Participants will be randomized 1:1, stratified by gender, language and tobacco use type to either:

§  Group 1: Varenicline + Positively Smoke Free-Mobile;

§  Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.

Participant data will be collected at baseline, 4-, 12- and 24-weeks post enrollment.This project proposes an open label, randomized controlled trial of 400 persons living with HIV who smoke or use smoked and smokeless tobacco and are in care for HIV in Chennai. Participants will be followed over 24 weeks. Participants will be randomized 1:1, stratified by gender, language and tobacco use type to either:

§  Group 1: Varenicline + Positively Smoke Free-Mobile;

§  Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.

Participant data will be collected at baseline, 4-, 12- and 24-weeks post enrollment.

 
Close