| CTRI Number |
CTRI/2024/02/062664 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EDUCATIONAL INTERVENTION] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of an educational intervention on knowledge and attitude towards LGBTQIA+ individuals among medical students in two medical colleges of Manipur |
|
Scientific Title of Study
|
Effect of an educational intervention on knowledge and attitude towards LGBTQIA+ individuals among medical students in two medical colleges of Manipur: A non-randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADHEENA BABU A |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL |
| Address |
POST GRADUATE TRAINEE,
DEPARTMENT OF COMMUNITY MEDICINE
REGIONAL INSTITUTE OF MEDICAL SCIENCES
IMPHAL
Imphal West
MANIPUR
795004
India |
| Phone |
9496123678 |
| Fax |
|
| Email |
adheenababu1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIJAYA ELANGBAM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL |
| Address |
ASSOCIATE PROFESSOR,
DEPARTMENT OF COMMUNITY MEDICINE,
REGIONAL INSTITUTE OF MEDICAL SCIENCES,
IMPHAL
Imphal West
MANIPUR
795004
India |
| Phone |
6909549534 |
| Fax |
|
| Email |
vijayaelangbam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ADHEENA BABU A |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL |
| Address |
POST GRADUATE TRAINEE,
DEPARTMENT OF COMMUNITY MEDICINE
REGIONAL INSTITUTE OF MEDICAL SCIENCES
IMPHAL
Imphal West
MANIPUR
795004
India |
| Phone |
9496123678 |
| Fax |
|
| Email |
adheenababu1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL |
|
|
Primary Sponsor
|
| Name |
ADHEENA BABU A |
| Address |
Post Graduate Trainee
Department of Community Medicine,
Regional Institute Of Medical Sciences, Imphal
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DR ADHEENA BABU A |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
Lecture hall, Community Medicine Department
Imphal West
MANIPUR |
09496123678
adheenababu1994@gmail.com |
| Dr Toijam Gambhir Singh |
SHIJA ACADEMY OF HEALTH SCIENCES |
Lecture Hall, Community Medicine Department
Imphal West
MANIPUR |
9436021662
drtoijamgambhir@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of Shija Hospitals |
Submittted/Under Review |
| Research Ethics Board, Regional Institute of Medical Sciences,Imphal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
No intervention will be given |
| Intervention |
Educational intervention |
Four sessions of 45 min duration will be conducted 2 weeks apart for the intervention group. Pre-test and two post-test will be conducted for both intervention and control group. Second post-test will be conducted 2 months after the first post-test .
Session I: Pre- test and introduction of the topic.
Session II: debate on LGBTQIA+ health education among medical undergraduates, group discussion on health care needs of LGBTQIA+.
Session III: Talk by a LGBTQIA+ representative, pamphlet distribution.
Session IV: case scenario discussion on how to behave with LGBTQIA+ individuals in clinical practice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Phase II and Phase III part 1 MBBS students enrolled in Regional Institute of Medical sciences and Shija Academy of Health Sciences |
|
| ExclusionCriteria |
| Details |
Those who are absent on any of the days of data collection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Knowledge about LGBTQIA+
2.Attitude towards LGBTQIA+
|
Four educational intervention sessions 2 weeks apart. First post-test along with fourth session and second post-test 2 months after the first post-test. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="454"
Sample Size from India="454"
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)
|
27/03/2024 |
| 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 Applicable |
| 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
|
The
adoption of the 2030 Agenda for Sustainable Development and its pledge to
“leave no one behind†and normative framework of international human rights law
has reinforced the need to understand and improve the health and well-being of
LGBTIQIA+ people. Sensitizing medical students about LGBTQIA+ healthcare needs
and building positive attitude in them will be one of the appropriate
preliminary step in attaining this goal.
An educational intervention study on knowledge
and Attitude towards LGBTQIA+ among MBBS students in two medical colleges
in Manipur will be carried out. Data will be
collected with the help of structured and pre-tested questionnaire containing
items on background characteristics, knowledge
and attitude towards LGBTQIA+. Data so collected will be analysed using
appropriate statistical methods. Data entry and analysis will be done on SPSS version 26.
Mean, standard deviation, frequency, Chi-square (χ2) test, paired
t-test, independent t-test, Kolmogorov Smirnov test, repeated measures ANOVA,
post-hoc test will be used for statistical analysis. |