| CTRI Number |
CTRI/2026/01/100394 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Reproductive and mental health needs and challenges in accessing health care among older adolescents in Udupi district Karnataka a qualitative study with adolescents parents teachers and health workers |
|
Scientific Title of Study
|
Perceived reproductive and psychosocial health problems and
determinants for accessing health care services among older adolescents (15-19 years) and key
stakeholders: a qualitative study from Southern Karnataka, India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidhi Deepak Rajkotia |
| Designation |
Postgraduate Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine
Kasturba Medical College (KMC), Manipal, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA
576104
India |
| Phone |
7208088806 |
| Fax |
|
| Email |
rajkotia.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Eshwari K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine ,Kasturba Medical College (KMC), Manipal, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA
576104
India |
| Phone |
9880460083 |
| Fax |
|
| Email |
eshwari.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Akhila Doddamani |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine ,Kasturba Medical College (KMC), Manipal, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA
576104
India |
| Phone |
9663703716 |
| Fax |
|
| Email |
akhila.d@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council Of Medical Research (ICMR),
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council Of Medical Research ICMRIndia |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| 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 |
| DrEshwari K |
Kasturba Medical College,Manipal |
Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi District, Karnataka, India – 576104
Udupi
KARNATAKA |
9880460083
eshwari.k@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Percieved Reproductive health problems (e.g. menstrual and genital health concerns) and psychosocial/mental health problems (e.g. stress, emotional distress) in older adolescents(15-19 years) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents (15 to 19 years) residing in Udupi district who provide assent or consent ;parents or legal guardians of adolescents (15 to 19 years); teachers or school counsellors;health workers;healthcare providers and programme implementers (RCHO and RBSK MO) with at least one year relevant experience willing to participate |
|
| ExclusionCriteria |
| Details |
Individuals with severe cognitive or communication impairments that prevent meaningful participation in discussions or interviews. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Understanding how older adolescents and key stakeholders perceive reproductive,mental and social health problems and challenges in accessing healthcare services. |
From baseline (March 2025) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of barriers & facilitators for health care access among adolescents(15-19 years) |
From Baseline (March 2025) |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/02/2026 |
| 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="2"
Months="4"
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
|
This qualitative study in Udupi district Karnataka will explore how older adolescents perceive reproductive and psychosocial health problems and the challenges they face in accessing health care services. Approximately three to four focus group discussions with adolescents in rural and urban areas and two in slum areas along with two to three focus group discussions each with parents, teachers and health workers and two to three in depth interviews with health care providers and one to two with programme implementers will be conducted using semi structured interview guides till data saturation is reached. All discussions and interviews will be audio recorded with prior consent translated and transcribed and participants will be selected purposively and will take part only after receiving information about the study in a language they understand and providing written informed consent and for adolescents written assent with parental consent where required. In addition the study includes a scoping review to summarise existing evidence from South Asia on barriers and facilitators to adolescent health care access and overall the expected outcome is a thematic understanding of personal social cultural and health system factors that act as barriers or facilitators to adolescents seeking reproductive and mental health care.
|