| CTRI Number |
CTRI/2025/06/089655 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative study design |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify and characterize preferred factors influencing acceptability and feasibility of potential targeted long-acting injectable ART regimens for children, adolescents and adults living with HIV in India |
|
Scientific Title of Study
|
Global Long-acting Drug Combination Development (GLAD) Project: Preferred User Characteristics Evaluation |
| Trial Acronym |
GLAD |
|
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 |
| Address |
VHS Infectious Diseases Medical Centre Department, Chennai Antiviral Research and Treatment (CART) Clinical Research Site, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai -600113
Chennai
TAMIL NADU
600113
India |
| Phone |
9176912007 |
| Fax |
|
| Email |
kumarasamy@cartcrs.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNKumarasamy |
| Designation |
Chief and Director |
| Affiliation |
VHS Infectious Diseases Medical Centre |
| Address |
VHS Infectious Diseases Medical Centre Department, Chennai Antiviral Research and Treatment (CART) Clinical Research Site, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai -600113
Chennai
TAMIL NADU
600113
India |
| Phone |
9176912007 |
| Fax |
|
| Email |
kumarasamy@cartcrs.org |
|
Details of Contact Person
Public Query
|
| Name |
DrNKumarasamy |
| Designation |
Chief and Director |
| Affiliation |
VHS Infectious Diseases Medical Centre |
| Address |
VHS Infectious Diseases Medical Centre Department, Chennai Antiviral Research and Treatment (CART) Clinical Research Site, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai -600113
Chennai
TAMIL NADU
600113
India |
| Phone |
9176912007 |
| Fax |
|
| Email |
kumarasamy@cartcrs.org |
|
|
Source of Monetary or Material Support
|
| National Institutes of Health NIH Maryland USA |
| Unitaid
Global Health Campus
Geneva Switzerland |
|
|
Primary Sponsor
|
| Name |
National Institutes of Health (NIH) |
| Address |
National Institutes of Health NIH
9000 Rockville Pike Bethesda
Maryland 20892 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNKumarasamy |
VHS Infectious Diseases Medical Centre |
VHS Infectious Diseases Medical Centre,
CART Clinical Research Site, Room No.3, First floor, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai -600113 India
Chennai
TAMIL NADU |
09176912007
kumarasamy@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Added in the summary section |
|
| ExclusionCriteria |
| Details |
Any individual who meets the following criteria will be excluded from participation in this study:
• Conditions that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study such as advanced HIV disease or other medical condition that impairs cognition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will identify and characterize preferred user characteristics influencing acceptability and feasibility of potential targeted long-acting injectable ART regimens for children, adolescents and adults living with HIV in India |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="650"
Sample Size from India="650"
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)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Study
Title
|
Global Long-acting Drug Combination Development (GLAD)
Project: Preferred User Characteristics Evaluation
|
|
Study
Design
|
Qualitative
and quantitative assessment of factors influencing product preferences and
use trajectories
|
|
Primary
Objective
|
To
identify and characterize preferred user characteristics influencing
acceptability and feasibility of potential targeted long-acting injectable
ART regimens for children, adolescents and adults living with HIV in India
|
|
Secondary
Objective(s)
|
NA
|
|
Research
Intervention(s)/Interactions
|
Focus
group discussions; surveys
|
|
Study
Population
|
People
living with HIV
Healthcare
providers of HIV services to people living with HIV
|
|
Sample
Size
|
Focus
Group Discussions: n=150 participants (15 focus groups)
Surveys: n=500
participants
|
|
Study
Duration for individual participants
|
Focus
Group Discussions: ~3 hours
Surveys:
~1 hour
|
|