| CTRI Number |
CTRI/2017/10/010230 [Registered on: 27/10/2017] Trial Registered Prospectively |
| Last Modified On: |
26/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
A study conducted on HIV patients to check their drug treatment, any unexpected reactions related to the treatment, to look for mental illness like saddnes,tension. |
|
Scientific Title of Study
|
Evaluation of impact of depression and its association to highly active antiretroviral therapy adherence and adverse drug reactions in people living with HIV |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
chinnu p roy |
| Designation |
Student |
| Affiliation |
|
| Address |
Department of Pharmacy Practice,
Manipal College of
Pharmaceutical sciences, Manipal,
Udupi,
KARNATAKA.
India
Dr. R. Rajesh
Co-PI(Guide)
Department of pharmacy practice
Manipal college of pharmaceutical sciences,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7019396840 |
| Fax |
|
| Email |
chinnuproy123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Rajesh |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Pharmacy Practice,
Manipal College of
Pharmaceutical sciences, Manipal,
Udupi,
KARNATAKA.
India
Chinnu P Roy
Student(M.Pharm)
Department of pharmacy practice
Manipal college of pharmaceutical sciences,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448374166 |
| Fax |
|
| Email |
rrajesh3775@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
chinnu p roy |
| Designation |
Student |
| Affiliation |
|
| Address |
Department of Pharmacy Practice,
Manipal College of
Pharmaceutical sciences, Manipal,
Udupi,
KARNATAKA.
India
Dr. R. Rajesh
Co-PI(Guide)
Department of pharmacy practice
Manipal college of pharmaceutical sciences,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7019396840 |
| Fax |
|
| Email |
chinnuproy123@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba medical college |
| Address |
Department Of General medicine
Kasturba Medical College,
Manipal,Udupi,Karnataka-576104 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| CHINNU P ROY |
Kasturba Medical College |
Department Of General Medicine
Manipal
Udupi
KARNATAKA |
7019396840
7019396840
chinnuproy123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HIV Associated Depression Patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1) Group 1 will consist of HIV-positive patients receiving HAART with depression (Cases). 2) Group 2 will consist of HIV-positive receiving HAART without depression (Controls). |
first group will consist of HIV-positive patients receiving HAART with depression (Cases) and second group will consist of HIV-positive receiving HAART without depression (Controls). These patients ADRs related to HAART will be accessed through their files. Only one visit will be required by the patient i.e. during Questionnaire assessment and rest of the information regarding ADRs will be collected through their files . Patients identified with depression will be brought to the notice of the doctor. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
HIV- seropositive patients (HIV-SPP) above 18 years of age, hospitalized in- patients and out
patients of either sex receiving HAART and HIV-SPP receiving HAART with symptoms of HIV
associated depression will be included. |
|
| ExclusionCriteria |
| Details |
HIV-SPP receiving HAART who refused for medication adherence and depression assessment
interview, patients with traditional medicines alone, pregnant women, HIV-SPP with chronic
kidney disease, rheumatoid arthritis, cancer patients, psychiatric co-morbidities, systemic lupus erythematosus, and patients with surgery within last three months will be excluded. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Severity of depression outcomes, HAART adherence outcomes and ADRs outcomes will be assessed and documented. |
Clinical data collection of the patient will be done at the time of their hospital visit.
Study will be done within 8 months of period. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| HAART Adherence and ADRs outcomes will be assessed and documented. |
Clinical data collection of the patient will be done at the time of their hospital visit.
Study will be done within 8 months of period |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
31/10/2017 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study just begins on 10/2017 after receiving the CTRI registration and hence have not yet commenced publishing procedures. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Evaluation of impact of depression and its association to highly active antiretroviral therapy adherence and adverse drug reactions in People living with HIV
Type of Study: A Prospective
Aim: To evaluate the impact of depression and its association to highly active antiretroviral therapy adherence and adverse drug reactions in People living with Human Immunodeficiency virus.
Objectives:
1.To assess the severity of depression in People living with Human Immunodeficiency virus on highly active antiretroviral therapy adherence . 2. To evaluate the impact of depression and its association to highly active antiretroviral therapy adherence in people living with Human Immunodeficiency virus. 3. To assess the impact of depression and its association to to highly active antiretroviral therapy adherence in people living with Human Immunodeficiency virus.
Need For the Study :
Worldwide, the Human Immunodeficiency virus (HIV) epidemic is one of the current health problems . In people living with Human Immunodeficiency virus (PLW-HIV), depression is the most commonly observed.Mental illness has surfaced with depression being the most common in these patients, which has markedly reduced patient adherence to HAART. HIV and depression is intricately intertwined.Studies from developed countries, reported that depression was signiï¬cantly associated with lower adherence to HAART and reduction in depressive symptoms with treatment over time was associated with improved adherence and also prevalence of depression was high and signiï¬cantly associated with non-adherence to HAART. PLW-HIV, after HAART initiation have to adapt to life with lifelong HAART treatment. The difficulties associated with HAART adherence and adverse drug reactions (ADRs) associated with use of HAART can lead to treatment failure and social stigma as shown negative impact on the quality of life in PLW-HIV. The presence of depressive symptoms and its correlations to HAART adherence and adverse drug reactions among HIV- positive patients in India has not been well documented. This study attempts to fulfill the gap by evaluating the impact of depression and its association to HAART adherence and ADRs in People living with HIV in Indian population.
Sample size : 200 Patients ( i.e. 100 patients in each group of cases and control).
Detailed description of procedure / processes : A prospective observational study will be conducted at the medicine department of Kasturba Hospital manipal. HIV-positive patients receiving HAART will be enrolled. Written informed consent will be obtained from these patients. During the visit, patient will be given two questionnaires which include the assessment of severity of depression using validated Patient health Questionnaire-9 (PHQ-9) 6 and The AIDS Clinical Trail Group (ACTG) adherence questionnaire 7 for medication adherence assessment. After assessment of severity of depression and medication adherence the information collected from the questionnaires will be divided into two groups. The first group will consist of HIV-positive patients receiving HAART with depression (Cases) and second group will consist of HIV-positive receiving HAART without depression (Controls). These patients ADRs related to HAART will be accessed through their files. Only one visit will be required by the patient i.e. during Questionnaire assessment and rest of the information regarding ADRs will be collected through their files . Patients identified with depression will be brought to the notice of the doctor.
The percentage of adherence from self-report will be calculated by using the following formula : No. of doses the patient should have taken – No .of doses missed × 100 Percentage of adherence = No. of doses the patient Should have taken
All the relevant data will be collected from patient’s case records and will be documented in a suitably designed ‘Individual case record form’ including the implication of HAART, OIs, number of drug prescribed, including demographic details of the patients, CD4 T-cell counts.
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