| CTRI Number |
CTRI/2024/08/072599 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
18/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Retrospective Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Adherence of People Living with HIV to Tenofovir, Lamivudine, and Dolutegravir treatment and its associated factors |
|
Scientific Title of Study
|
A retrospective analysis of adherence rate and associated factors in a Tenofovir, Lamivudine, and Dolutegravir based regimen in People Living with HIV |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharwani Vijayshree Lal |
| Designation |
Junior Resident MD Pharmacology |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
8802930485 |
| Fax |
|
| Email |
drsharwanilal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjleen Kaur |
| Designation |
Associate Professor and Supervisor |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9855210999 |
| Fax |
|
| Email |
anjleen9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjleen Kaur |
| Designation |
Associate Professor and Supervisor |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9855210999 |
| Fax |
|
| Email |
anjleen9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Sangrur Road, Patiala, Punjab, India-147001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Patiala |
| Address |
Government Medical College, Patiala, Punjab, 147001 |
| Type of Sponsor |
Government medical college |
|
|
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 Sharwani Vijayshree Lal |
Government Medical College and Rajindra Hospital, Patiala, Punjab |
Room No. 15 (Ground Floor)- ART Centre under Department of Medicine
Patiala
PUNJAB |
08802930485
drsharwanilal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients above the age of 18 years
2) Patients diagnosed with HIV
3) PLHIV registered at ART Centre in Government Medical College and Rajindra Hospital, Patiala
4) Treatment naïve PLHIV initiated on Tenofovir 300 mg, Lamivudine 300 mg, Dolutegravir 50 mg, fixed-dose combination regimen
5) PLHIV on TLD with a minimum of 2 drug refills irrespective of follow-up period
|
|
| ExclusionCriteria |
| Details |
1) Records with incomplete data on ART adherence
2) PLHIV not on Tenofovir 300 mg, Lamivudine 300 mg, Dolutegravir 50 mg, fixed-dose combination regimen
3) PLHIV whose ART regimen was switched during the study period
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Adherence rate in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.
2) Factors associated with adherence in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.
|
Medical records for all patients put on anti-retroviral therapy fulfilling the inclusion and exclusion criteria will be reviewed on a retrospective basis for a duration of three consecutive months.
All visits that the patient has completed within a period of one year from date of initiation of ART will be considered. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Adherence between different age groups in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.
2) Adherence between gender in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.
3) Adherence between socio-economic classes in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.
4) Adherence between WHO Clinical Stages in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen. |
Medical records for all patients put on anti-retroviral therapy fulfilling the inclusion and exclusion criteria will be reviewed on a retrospective basis for a duration of three consecutive months.
All visits that the patient has completed within a period of one year from date of initiation of ART will be considered. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
27/08/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A retrospective analysis of adherence rate and associated factors in a Tenofovir, Lamivudine, and Dolutegravir based regimen in People Living with HIV Introduction: Dolutegravir, a key component of the TLD regimen, has a high barrier to resistance and is well-tolerated by patients. Despite these advantages, adherence to ART remains a critical challenge that affects treatment outcomes. Thus, we plan to conduct a retrospective analysis to explore adherence rates to the Tenofovir, Lamivudine, and Dolutegravir regimen among People Living with HIV (PLHIV) and associated factors at the ART Centre, Government Medical College and Rajindra Hospital, Patiala. Aims & Objectives:The primary objective of the research includes determining the adherence rate and identifying factors associated with adherence in PLHIV on the TLD regimen. The secondary objective includes comparing adherence between different age groups, genders, socio-economic classes, and WHO Clinical Stages in PLHIV on the TLD regimen. Materials and Methods: It is a retrospective study of PLHIV who are registered at the ART Centre at Government Medical College & Rajindra hospital, Patiala and initiated on TLD regimen. Medical records for all patients fulfilling the inclusion and exclusion criteria will be reviewed on a retrospective basis for a duration of three consecutive months. Data will be collected on a predesigned semi structured case record form and will be analyzed using appropriate statistical tests. Clinical Significance: By elucidating factors contributing to adherence and its impact on treatment outcomes, this study seeks to inform targeted interventions aimed at enhancing adherence and optimizing HIV care delivery. Key words: Dolutegravir, Adherence, HIV, TLD regimen |