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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000001092
受付番号 R000001251
科学的試験名
一般公開日(本登録希望日) 2008/03/26
最終更新日 2010/02/13

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
一般向け試験名略称/Acronym
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
科学的試験名/Scientific Title
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
科学的試験名略称/Scientific Title:Acronym
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
試験実施地域/Region
南米/South America

対象疾患/Condition
対象疾患名/Condition
HIV / AIDS
疾患区分1/Classification by specialty
感染症内科学/Infectious disease
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/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.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
Compliance to Anti-Retroviral Therapy among African-Brazilians in Southern Brazil
試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/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.
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation はい/YES
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 7
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/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






介入2/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
介入3/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

介入4/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)

介入5/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

介入6/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)

介入7/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
介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit

適用なし/Not applicable
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/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.

除外基準/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).

目標参加者数/Target sample size 100

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム


ミドルネーム
Carlos Zubaran
所属組織/Organization
University of Caxias do Sul, Brazil
所属部署/Division name
The Biological and Health Sciences Center
郵便番号/Zip code
住所/Address
Prof. Getulio Vargas street, 1130
電話/TEL 555432182100
Email/Email

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム
Carlos Zubaran
組織名/Organization
University of Caxias do Sul, Brazil
部署名/Division name
The Biological and Health Sciences Center
郵便番号/Zip code
住所/Address
Prof. Getulio Vargas street, 1130
電話/TEL 555432182100
試験のホームページURL/Homepage URL
Email/Email zubaran_jr@yahoo.com

実施責任組織/Sponsor
機関名/Institute その他 University of Caxias do Sul, Brazil
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 UNESCO
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2008 03 26

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2005 04 30
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2005 05 01
フォロー終了(予定)日/Last follow-up date
2009 03 01
入力終了(予定)日/Date of closure to data entry
2009 06 01
データ固定(予定)日/Date trial data considered complete
2009 06 01
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2008 03 20
最終更新日/Last modified on
2010 02 13


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000001251
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001251

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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