UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001092 |
|---|---|
| Receipt number | R000001251 |
| Scientific Title | Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil |
| Date of disclosure of the study information | 2008/03/26 |
| Last modified on | 2010/02/13 07:38:59 |
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Basic information
Public title
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
Acronym
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
Scientific Title
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
Scientific Title:Acronym
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
Region
| South America |
Condition
Condition
HIV / AIDS
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if racism and discrimination negatively influence compliance to anti-retroviral therapy.
To investigate if different levels of satisfaction with health services influence compliance to anti-retroviral therapy.
To investigate if alcohol or drug abuse significantly influence compliance to anti-retroviral therapy.
To investigate if the use of a strategy for behavioral modification (MATI) can increase compliance to anti-retroviral therapy in comparison to volunteers treated with conventional methodologies.
Basic objectives2
Others
Basic objectives -Others
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate if the Portuguese versions of the tested instruments present internal validity for future in Brazil.
To investigate if different rates of compliance to anti-retroviral therapy are correlated to distinct immunologic and serologic paradigms.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initial assessment while still in hospital during two interviews:
1.
1.1 Signature of the consent form
1.2 Test of knowledge about the research protocol
1.3 Demographics characteristics
1.4 Assessment of social and economic states
2.
2.1 MATI Initial evaluation (≈ 60 minutes) or non-MATI conventional interview
2.2 Review of blood exams results
2.3 Scheduling of next collection of exams (CD4, viral load, genotyping)
2.4 Scheduling of the first outpatient interviews
Interventions/Control_2
Time 15 days
First outpatient appointment and research interview:
1) Guidelines form for conventional interview or MATI interview
2) Initial ACTG
3) Racists Events Questionnaire
4) SRQ Questionnaire
5) QSCl & QSCo Questionnaires
Interventions/Control_3
Time 45 days
Second outpatient appointment and research interview:
1) Presentation of exams (CD4, viral load, genotyping)
2) Guidelines form for conventional interview or MATI interview
3) Hamilton Depression
4) MADRS Depression
5) Hamilton Anxiety
6) Personal Health Questionnaire
7) WHO-QOL HIV
8) Beck Depression
9) IDATE-T
10)IDATE-E
Interventions/Control_4
Time 75 days
Third outpatient appointment and research interview:
* MATI follow up interview or non-MATI conventional interview
1) Scale of Social Adequacy
2) ASSIST
3) Scheduling of next collection of exams (CD4, viral load, genotyping)
Interventions/Control_5
Time 105 days
Fourth outpatient appointment and research interview:
1) Guidelines form for conventional interview or MATI interview
2) SMAQ Questionnaire
3) ACTG Follow Up Questionnaire
Interventions/Control_6
Time 135 days
Fifth outpatient appointment and research interview:
1) Review of blood exams results
2) Guidelines form for conventional interview or MATI interview
3) Vaccination Questionnaire
4) Delivery of research bonus (10 meal vouchers)
Interventions/Control_7
Time 225 days / 10 months
1) MATI follow up interview or non-MATI conventional interview
2) Hamilton Anxiety Questionnaire
3) Hamilton Depression Questionnaire
4) Beck Depression Questionnaire
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HIV infected patients admitted to the University of Caxias do Sul General Hospital due to Clinical complications of AIDS who will need Anti-Retroviral Therapy.
Key exclusion criteria
1) Patients that don't have permanent abode or with localization's problems and accompaniment, or
2) Patients with physically or mental disturbs that can compromise the dislocation to research's places, or performance to participate about evaluations or logic and veracity of information (serious alterations of mental state).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Carlos Zubaran |
Organization
University of Caxias do Sul, Brazil
Division name
The Biological and Health Sciences Center
Zip code
Address
Prof. Getulio Vargas street, 1130
TEL
555432182100
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Carlos Zubaran |
Organization
University of Caxias do Sul, Brazil
Division name
The Biological and Health Sciences Center
Zip code
Address
Prof. Getulio Vargas street, 1130
TEL
555432182100
Homepage URL
zubaran_jr@yahoo.com
Sponsor or person
Institute
University of Caxias do Sul, Brazil
Institute
Department
Personal name
Funding Source
Organization
UNESCO
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 06 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 20 | Day |
Last modified on
| 2010 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001251
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
