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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001092
Receipt No. 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

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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
Email

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
Email zubaran_jr@yahoo.com

Sponsor
Institute University of Caxias do Sul, Brazil
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001251

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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