| CTRI Number |
CTRI/2021/06/034383 [Registered on: 25/06/2021] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effectiveness of nurse-led multi-component intervention program me (NLMIP) on improving Antiretroviral therapy(ART) adherence, CD-4 Count & Quality of life of people living with HIV/AIDS(PLWHA) attending ART centre of selected hospital of Delhi. |
|
Scientific Title of Study
|
A study to assess the effectiveness of nurse-led multi-component intervention program me (NLMIP) on improving Antiretroviral therapy(ART) adherence, CD-4 Count & Quality of life of people living with HIV/AIDS(PLWHA) attending ART centre of selected hospital of Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONIA GULATI |
| Designation |
NURSING TUTOR |
| Affiliation |
Dr. RML Hospital & PGIMER |
| Address |
Medical-Surgical Nursing Department, College Of Nursing, Dr. RML Hospital, New Delhi
Baba Kharak Singh Marg, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
09654562036 |
| Fax |
|
| Email |
soniaarorarml@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pulin Kumar Gupta |
| Designation |
Professor, Department of medicine |
| Affiliation |
ABVIMS & Dr. RML Hospital |
| Address |
ABVIMS & Dr. RML Hospital, New Delhi
Baba Kharak Singh Marg, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9899748321 |
| Fax |
|
| Email |
guptapulin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SONIA GULATI |
| Designation |
NURSING TUTOR |
| Affiliation |
ABVIMS & Dr. RML Hospital |
| Address |
Medical-surgical nursing department, College Of Nursing, Dr. RML Hospital, New Delhi
Baba Kharak Singh Marg, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
09654562036 |
| Fax |
|
| Email |
soniaarorarml@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS & Dr. RML Hospital, new delhi |
|
|
Primary Sponsor
|
| Name |
Sonia Gulati |
| Address |
college of nursing, ABVIMS & Dr. RML hospital, new delhi |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Pulin Kumar Gupta |
ABVIMS & Dr. RML Hospital, new delhi |
ART centre, Department of Medicine, ABVIMS & Dr. RML Hospital, Baba kharak singh marg, new delhi
New Delhi
DELHI |
9899748321
guptapulin@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ABVIMS AND DR RML HOSPITAL NEW DELHI |
Approved |
| ABVIMS and DR. RML HOSPITAL, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: D809||Immunodeficiency with predominantly antibody defects, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NURSE LED MULTICOMPONENT INTERVENTION PROGRAMME FOR PEOPLE LIVING WITH HIV/AIDS |
A nursing educational intervention on various components given by the investigator to the experimental group of PLWHA with regards to general health education for all adult PLWHA, specific education for HIV-positive mothers, Behaviour modification education, education on psychological care, session on how to think positive & psychosocial support including family education. Total duration of the nursing intervention will be from 70 to 90 minutes. follow up will be done for 6 months. |
| Comparator Agent |
usual care |
usual education given to hiv patients by health care workers |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- Newly diagnosed HIV/AIDS patients(Prescribed on ART)
- Aged 18 years or above
- Willing to participate in the study
- Can speak and understand Hindi/English
- Can come for regular follow ups & attending A.R.T clinic of Dr. RML HOSPITAL, New Delhi
|
|
| ExclusionCriteria |
| Details |
- PLWHA with mental illness and unable to communicate
- Adolescent and pediatric age groups
- Not giving consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ART adherence, CD4 count, quality of life |
0, 3 , 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no opportunistic infections |
at 3rd month & at 6th month of follow ups in intervention group |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/07/2021 |
| 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="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
RANDOMIZED control trial to assess the effectiveness of nurse led multicompnent intervention programme on improving ART adherence, CD4 count & quality of life of people living with HIV/AIDS and attending ART centre of selected hospital of delhi. paritcipant will be enrolled based on inclusion criteria. those ready to participate will be given patient information sheet. informed consent will be taken. baseline data will be taken. participants will be randomized into two groups. experimental group will be given NLMIP. control group will be given usual care. follow up will be done at 0, 3rd & 6th months. data will be collected by standardized tools. data will be analyzed as per statistical methods. |