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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: |
PACTR2010060002133418 |
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Date of registration:
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26/05/2010 |
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Primary sponsor: |
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Public title:
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Top-Up Study
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Scientific title:
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A study to determine the feasibility of conducting a microbicide trial of daily vaginal gel and to inform the way adherence should be assessed |
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Date of first enrolment:
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2010-06-01 |
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Target sample size:
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225 |
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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=PACTR2010060002133418 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Simple randomisation using a radomisation table created by a computer software program ,
Sealed opaque envelopes,
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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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Angela
Crook |
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Address:
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222 Euston Road
NW1 2DA
London
United Kingdom |
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Telephone:
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+44 207 670 4751 |
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Email:
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acr@ctu.mrc.ac.uk |
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Affiliation:
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Statistician |
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Name:
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Lisa
Burch |
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Address:
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Stephenson House, 158-160 North Gower Street
NW1 2ND
London
United Kingdom |
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Telephone:
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+44 207 670 4858 |
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Email:
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lib@ctu.mrc.ac.uk |
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Affiliation:
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Trial Manager |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women aged 18 years and above at enrolment
Likely to be sexually active at entry and during follow-up
Willing to use study gel as instructed
Willing to return applicators every week day
Willing to attend the clinic every 4 weeks and be interviewed
Willing to be followed up and interviewed if she defaults
Willing to receive health education about condoms
Willing to undergo pregnancy tests on a monthly basis
Willing and able to give informed consent
Exclusion criteria: Using a product in a trial, or otherwise e.g. licensed spermicide, that is likely to impact on the outcome of this study and she is unwilling to stop use for the duration of study
Unable to agree a reliable method of contact with the field team
Likely to move out of the area within the next 3 months
Pregnant (including positive pregnancy test at enrolment)
Has clinical condition considered by the study management group to make enrolment inadvisable
Considered by the study personnel to be unlikely to be able to comply with the study procedures
Previously enrolled on MDP301 trial
Age minimum:
18 Year
Age maximum:
99 Year
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
null
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Primary Outcome(s)
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Adherence to daily use of gel
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Secondary Outcome(s)
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Consistency of adherence measure
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Reasons for non-adherence
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Retention
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Source(s) of Monetary Support
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CONRAD
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UK Medical Research Council
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European & Developing Countries Clinical Trials Partnership
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International Partnership for Microbicides
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UK Department for International Development
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