| CTRI Number |
CTRI/2020/06/025669 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
22/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Video based educational intervention among HIV positive patients |
|
Scientific Title of Study
|
Effectiveness of Video-based Educational Intervention on Stigma, ART Adherence and Quality of Life in HIV positive patients in India: A Multicentric Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Irene Lalhruaimawii |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room number 5
Department of Pharmacy Practice
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8731058645 |
| Fax |
|
| Email |
irene.kawlni@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhakrishnan Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room number 7
Department of Pharmacy Practice
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448374166 |
| Fax |
|
| Email |
rajesh.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhakrishnan Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room number 7
Department of Pharmacy Practice
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448374166 |
| Fax |
|
| Email |
rajesh.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education
Udupi, Karnataka
576104 |
| Type of Sponsor |
Other [Deemed to be University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Irene Lalhruaimawii |
ART Center |
Civil Hospital
Aizawl, Mizoram
796001
Aizawl
MIZORAM |
8731058645
irene.kawlni@learner.manipal.edu |
| Irene Lalhruaimawii |
Kasturba Hospital |
Kasturba Hospital
MAHE,Manipal
Karnataka
576104
Udupi
KARNATAKA |
8731058645
irene.kawlni@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Civil Hospital, Aizawl |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Video-based Education |
The video-based intervention mainly focuses on educating patients about the importance of adhering to ART medication regimen, ways to reduce existing stigma so that available healthcare facilities could be utilized more effectively and directing positive approaches towards psychological well-being among people living with the disease to improve their overall Quality of life. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
People living with HIV/AIDS for more than 18 years
Receive ART for more than 6 months
Patients who have and can access smartphone
|
|
| ExclusionCriteria |
| Details |
Patients who are unwilling and unable to sign Informed Consent.
Patients with visual impairment, hearing loss.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help in identifying patient’s ART adherence behavior and the causal relationship with evidence-based stigmas and QOL among the HIV positive patients. |
Expected from 30-36 months from date of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The developed video-based intervention will help in reducing the existing stigma, improve QOL and increase ART adherence and can be applied to a greater extent. |
Expected from 30-36 months from date of recruitment |
|
|
Target Sample Size
|
Total Sample Size="572"
Sample Size from India="572"
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)
|
01/07/2020 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study results will be published in scientific citation indexed journals
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All enrolled subjects of either in or outpatients will be interviewed with baseline assessment using HIV Stigma Scale, ABQ-HIV Scale and WHOQOL-HIV BREF Scale.There are two arms in the study; standard care group and intervention group. Intervention group will be receiving a video-assisted educational intervention which mainly focuses on educating patients about importance of adhering ART medication regimen, ways to reduce existing stigma so that available healthcare facilities could be utilized more effectively and directing positive approaches towards psychological well-being among people living with the disease to improve their overall Quality of Life. Among Standard care group, standard medical care will be provided by physicians and nursing staffs. |