| CTRI Number |
CTRI/2023/01/048982 [Registered on: 13/01/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Preparation of course on healthcare of LGBT. |
|
Scientific Title of Study
|
Integrated health care of LGBT: Development of curriculum and capacity building of health care providers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamatha Shivananda Pai |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education(MAHE), Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448623789 |
| Fax |
|
| Email |
mamatha.spai@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamatha Shivananda Pai |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education(MAHE), Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448623789 |
| Fax |
|
| Email |
mamatha.spai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mamatha Shivananda Pai |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education(MAHE), Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448623789 |
| Fax |
|
| Email |
mamatha.spai@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research(ICMR) |
| Address |
Indian Council of Medical Research, Ansari Nagar, Post Box No. 4911, New Delhi- 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Mamatha Shivananda Pai |
Manipal College of Nursing, Manipal |
Project room, 6th floor, Department of pediatric nursing, Manipal
Udupi
KARNATAKA |
9448623789
mamatha.spai@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Any members of the LGBT community who can speak in Kannada/English and are willing to participate in the Focus group discussion.
Faculty- Nursing, Medicine, Psychology, Nurse educator, KH.
Students- Nursing-PG, Medicine PG, Psychology- MPhil, Head nurses, KH.
|
|
| ExclusionCriteria |
| Details |
Any person who is not belonging to the LGBT community.
Any individuals who are crossdressers.
Any member of the LGBT community who has a diagnosed mental disorder listed under chapter F of ICD 10, except gender identity disorder.
Administrators.
UG Students. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health needs of LGBT individuals through FGD. |
Exploring health needs through FGD at single point. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge level of healthcare on LGBT. |
Knowledge level at Pre and Post test. Baseline and day 2. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/01/2023 |
| Date of Study Completion (India) |
05/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Developing a module on the care of LGBTQIA+
individuals for health professionals: Research protocol. - F1000Research |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
LGBT+ or gender variant people struggle to identify a health care service that understands their problems and needs. Health care professional also find it difficult to care for the LGBT+ as very little is studied or heard about management. The new curriculum will have the topics related to the health care needs of the LGBT+ that will be developed based on the literature review and focus group discussion among the LGBT+ people. |