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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.: PACTR2009070001314037 Date registered: 2009/03/20
TRIAL DESCRIPTION
Public title ARK Kraaifontein PMTCT trial
Official scientific title ARK Kraaifontein PMTCT trial
Brief summary describing the background
and objectives of the trial
A randomised control trial evaluating whether the South African Department of Health (DOH) should be providing community health workers, called patients advocates (PAs), and triple ARV regimens to all HIV positive pregnant women using the public health service as part of a comprehensive package for PMTCT?
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ARKKFTN
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up 2009-07-31
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 500   
Recruitment status Terminated
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
Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group triple ARV therapy+Patient advocate Standard from booking till 18 months post partum for PA as for control arm for ARVs A Patietn advocate is a community health worker 250 Active
Control group triple ARV therapy standard from booking till 6 weeks post weaning AZT/3TC and Kaletra 250 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Pregnant, HIV positive, booking at Kraaifontein or Durbanville clinics Qualifies for lifelong antiretroviral treatment 18 nulls 99 nulls 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 2008/11/17 University of Cape Town Ethics committee
Ethics Committee Address
Street address City Postal code Country
Old Main Building Groote Schuur Hospital ANzio Rd Observatory Cape Town 7925 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Infant PCR uptake 6 weeks

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kraafontein Day Hospital Sesde Laan Cape Town 7570 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
Absolute Return for Kids 37 Hares Ave Woodstock Cape Town 7705 South Africa
Absolute Return for Kids 37 Hares Ave Woodstock Cape Town 7705 South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Absolute Return for Kids 37 Hares Ave. Cape Town 7705 South Africa Company
Primary Sponsor Absolute Return for Kids 37 Hares Ave. Cape Town 7705 South Africa Company

COLLABORATORS
Name Street address City Postal code Country
Medical Research Council PO Box 19070 Cape Town 7505 South Africa
Medical Research Council PO Box 19070 Cape Town 7505 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Mr Nickesh Maharaj nickesh@arkonline.org 27 31 2691167
Street address City Postal code Country Position / Affiliation
7 Dodoma Avenue, Clare Estate, 4091 Durban 4091 South Africa In charge of closing down the trial
Role Name Email Phone Fax
Scientific Enquiries Mr Nickesh Maharaj nickesh@arkonline.org 27 31 2691167
Street address City Postal code Country Position / Affiliation
7 Dodoma Avenue, Clare Estate, 4091 Durban 4091 South Africa In charge of closing down the trial
Role Name Email Phone Fax
Principal Investigator Dr Ashraf Grimwood agrimwoo@iafrica.com +27828825770
Street address City Postal code Country Position / Affiliation
VINE PARK HEALTH & WELLNESS CENTRE, Vine Park Rd, Woodstock,7925 Cape Town 7705 South Africa Head