Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2010060002133418 Date of Approval: 26/05/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Top-Up Study
Official scientific title A study to determine the feasibility of conducting a microbicide trial of daily vaginal gel and to inform the way adherence should be assessed
Brief summary describing the background and objectives of the trial Objectives: 1) To determine the feasibility of once-daily use of a vaginal microbicide gel 2) To inform the way adherence is assessed in a future clinical trial
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/06/2010
Actual trial start date
Anticipated date of last follow up 30/09/2010
Actual Last follow-up date
Anticipated target sample size (number of participants) 225
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A Daily insertion of 4ml HEC placebo gel 12 weeks Return applicators daily 75
Experimental Group Group B Daily insertion of 4ml HEC placebo gel 12 weeks Return applicators weekly 75
Control Group Group C Daily insertion of 4ml HEC placebo gel 12 weeks Return applicators every 4 weeks 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 18 Year(s) 99 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/03/2009 The University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus, PO Box 50110 Lusaka Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/04/2009 National Committee of Bioethics for Health
Ethics Committee Address
Street address City Postal code Country
Av. Eduardo Mondlane/Salvador Allende Maputo 264 Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/03/2010 Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Westville Campus, Govan Mbeki Building Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/08/2009 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
PO Box 9653 Dar es Salaam Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/04/2009 Uganda Virus Research Institute Science and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 49 Entebbe Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to daily use of gel 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Consistency of adherence measure 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Retention 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Reasons for non-adherence 4 weeks, 8 weeks, 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centro de Investigacao em Saude da Manhica Rua 12, PO 1929 Manhica Mozambique
HIV Prevention Research Unit, Medical Research Council PO Box 70380 Durban Overport 4067 South Africa
Mwanza Intervention Trials Unit, NIMR PO Box 11936 Mwanza Tanzania
MRC Programme on AIDS, Uganda Virus Research Institute PO Box 49 Entebbe Uganda
MDP Programme Zambia PO Box 670555 Mazabuka Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
UK Department for International Development 1 Palace Street London SW1E 5HE United Kingdom
UK Department for International Development 1 Palace Street London SW1E 5HE United Kingdom
UK Medical Research Council 20 Park Crescent London W1B 1AL United Kingdom
UK Medical Research Council 20 Park Crescent London W1B 1AL United Kingdom
European & Developing Countries Clinical Trials Partnership PO Box 93015, 2509 The Hague Netherlands
European & Developing Countries Clinical Trials Partnership PO Box 93015, 2509 The Hague Netherlands
CONRAD 1911 North Fort Myer Dr., Suite 900 Arlington VA 22209 United States of America
CONRAD 1911 North Fort Myer Dr., Suite 900 Arlington VA 22209 United States of America
International Partnership for Microbicides 8401 Colesville Road, Suite 200 Silver Spring MD 20910 United States of America
International Partnership for Microbicides 8401 Colesville Road, Suite 200 Silver Spring MD 20910 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council 20 Park Crescent London W1B 1AL United Kingdom Commercial Sector/Industry
Primary Sponsor Medical Research Council 20 Park Crescent London W1B 1AL United Kingdom Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Barcelona Centre for International Research (CRESIB) Universitat de Barcelona, Rossello 132, 4a planta Barcelona 08036 Spain
Barcelona Centre for International Research (CRESIB) Universitat de Barcelona, Rossello 132, 4a planta Barcelona 08036 Spain
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Robert Pool robert.pool@cresib.cat +34 932275706 Universitat de Barcelona, Rossello 132, 4a planta
City Postal code Country Position/Affiliation
Barcelona 08036 Spain
Role Name Email Phone Street address
Public Enquiries Lisa Burch lib@ctu.mrc.ac.uk +44 207 670 4858 Stephenson House, 158-160 North Gower Street
City Postal code Country Position/Affiliation
London NW1 2ND United Kingdom Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Angela Crook acr@ctu.mrc.ac.uk +44 207 670 4751 222 Euston Road
City Postal code Country Position/Affiliation
London NW1 2DA United Kingdom Statistician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information