| CTRI Number |
CTRI/2026/01/102101 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Holistic Nursing Intervention on Health Status of People Living with HIV. |
|
Scientific Title of Study
|
A study to assess the efficacy of holistic nursing intervention on drug adherence, CD4 count, viral load, depression and functional well being among people living with HIV/AIDS at ART centre, District Government Hospital, Bagalkot |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Kavita Patil |
| Designation |
PhD Scholar |
| Affiliation |
BVVS Sajjalashree Institute of Nursing Sciences |
| Address |
Department of Psychiatric Nursing, Mental Health Devision, Room No. 4
BVVS Sajjalashree Institute of Nursing Sciences, Navanagar, Bagalkote
Bagalkot
KARNATAKA
587103
India |
| Phone |
8951889862 |
| Fax |
|
| Email |
kavita.kp47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shriharsha C |
| Designation |
Professor and HOD |
| Affiliation |
BVVS Sajjalashree Institute of Nursing Sciences |
| Address |
Department of Psychiatric Nursing, Mental Health Devision, Room No. 4
BVVS Sajjalashree Institute of Nursing Sciences, Navanagar, Bagalkote
Bagalkot
KARNATAKA
587103
India |
| Phone |
9845777592 |
| Fax |
|
| Email |
harsha592@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shriharsha C |
| Designation |
Professor and HOD |
| Affiliation |
BVVS Sajjalashree Institute of Nursing Sciences |
| Address |
Department of Psychiatric Nursing, Mental Health Devision, Room No. 4
BVVS Sajjalashree Institute of Nursing Sciences, Navanagar, Bagalkote
Bagalkot
KARNATAKA
587103
India |
| Phone |
9845777592 |
| Fax |
|
| Email |
harsha592@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sajjalashree Institute of Nursing Sciences Bagalkot Karnataka India |
| Address |
Department of Psychiatric Nursing, Mental Health Devision, Room No. 4
BVVS Sajjalashree Institute of Nursing Sciences, Navanagar, Bagalkote-587103 |
| 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 |
| Mr Shankar Shinde |
District Hospital |
Department of HIV Medicine, ART Division, Room No.5, District Government Hospital, Bagalkote, 587103
Bagalkot
KARNATAKA |
9964177635
researchatitsbest@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS COMMITTEE SIONS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D818||Other combined immunodeficiencies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOLISTIC NURSING INTERVENTION |
Holistic nursing intervention includes structured health education, medication adherence counselling, psychosocial support, depression management strategies and lifestyle guidance provided to people living with HIV to improve drug adherence, immune status, mental wellbeing and functional wellbeing. |
| Comparator Agent |
STANDARD ROUTINE CARE |
Standard routine care includes routine antiretroviral therapy services and usual counselling provided at the ART centre without structured holistic nursing intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
People living with HIV aged 18 to 60 years, on antiretroviral therapy including second line ART, with viral load more than 1000 copies, recent CD4 count and viral load reports within one month, regular follow up for the past three months, and able to read and write Kannada or English. |
|
| ExclusionCriteria |
| Details |
Critically ill patients, individuals with severe psychiatric illness, cognitive impairment, or those unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in drug adherence, CD4 count, viral load, depression and functional wellbeing |
Pretest (Baseline)
Immediate Post Intervention (First Month)
Second Month Post Intervention
Third Month Post Intervention
Sixth Month Post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
01/06/2026 |
| 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="6"
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 study aims to evaluate the efficacy of holistic nursing intervention on drug adherence, CD4 count, viral load, depression and functional wellbeing among people living with HIV. A true experimental pre test post test control group design will be used. Eligible participants will be randomly allocated into experimental and control groups. The experimental group will receive holistic nursing intervention for 30 days, while the control group will receive standard care. Outcomes will be assessed at baseline, immediate post intervention, and follow up at 60, 90 and 180 days. |