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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201106000288379 |
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Date of registration:
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12/04/2011 |
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Primary sponsor: |
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Public title:
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"Bridging the gap". Evaluating new rapid diagnostic tests for Mycobacterium tuberculosis (MTB) disease
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Scientific title:
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Preventing adverse outcomes in smear negative TB suspects in the era of collaborative TB and HIV programmes: the contribution of new TB diagnostics |
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Date of first enrolment:
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2011-04-07 |
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Target sample size:
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766 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201106000288379 |
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Study type:
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interventional |
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Study design:
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Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,
Randomised,
Block randomization using a computer software program,
The randomization list was generated on lab ID numbers for sputum specimens. received specimens are allocated lab IDs and the technologist processing specimens is given the randomization list after allocating specimen IDs ,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Lucy
Mupfumi |
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Address:
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4th Floor Nicoz Diamond House cnr Samora Machel and park street
00000
Harare
Zimbabwe |
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Telephone:
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002634735000/2 |
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Email:
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lmupfumi@gmail.com |
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Affiliation:
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researcher |
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Name:
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Reggie
Mutetwa |
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Address:
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4th Floor Nicoz Diamond House cnr Samora Machel and park street
00000
harare
Zimbabwe |
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Telephone:
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002634735000/2 |
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Email:
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rmutetwa@gmail.com |
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Affiliation:
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Researcher |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria for the trial:
? TB suspect with cough for 2 or more weeks;
? Age 16 years or above;
? Usual residence within catchment area for local clinic;
? Able and willing to participate in answering questions, and providing sputum and blood specimen for storage and HIV testing;
? Willing to consent to study follow-up at 3 months, with a home visit if necessary;
? Able and willing to provide informed written consent.
Exclusion criteria: ? Age 15 years or younger
? Usual residence anywhere other than in catchment area of local clinic
? Unable to unwilling to answer questions
? Unable or unwilling to provide written informed consent or samples
Age minimum:
16 Year
Age maximum:
99 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
Tuberculosis
null
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Primary Outcome(s)
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Risk for adverse events (death, IRIS and delayed TB diagnosis)
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Secondary Outcome(s)
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Time to treatment initiation
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Source(s) of Monetary Support
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Clinical Infectious Disease Research Initiative, University of Capetown
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