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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: www.pactr.org

Trial no.: PACTR201308000586211 Date registered: 2013/07/09
TRIAL DESCRIPTION
Public title Vertical transmission study
Official scientific title A cohort study to assess the impact of a breastfeeding counselling and support strategy to promote exclusive breastfeeding on post-natal transmission of HIV in African women
Brief summary describing the background
and objectives of the trial
A cohort study of HIV-infected mothers and their infants, to determine the rate of HIV MTCT following intensive breastfeeding counselling and support to practise EBF until about 6 months of age. Main aims of the study are to estimate the effect of different infant feeding practices on MTCT rates at 1, 6 and 18-22 weeks of age among women who EBF their babies. A random sub-sample of HIV-uninfected women will be also recruited to compare breastfeeding practices and outcomes in this population.
Type of trial Others
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date 2001-09-03
Actual trial start date 2001-10-29
Anticipated date of last follow up 2005-10-31
Actual date of last follow up 2006-10-20
Anticipated target sample size (number of participants) 2500   
Actual target sample size (number of participants) 3465   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender

ETHICS APPROVAL

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country

FUNDING SOURCES
Name of source Street address City Postal code Country

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor

COLLABORATORS
Name Street address City Postal code Country

CONTACT PEOPLE
Role Name Email Phone Fax
Scientific Enquiries Dr Nigel Rollins rollinsn@who.int +41 22 7914624 +41 22 7914856
Street address City Postal code Country Position / Affiliation
Dept Maternal, Newborn, Child and Adolescent Health , WHO, Avenue Appia 20 Geneva 1211 Switzerland Scientist