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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2009070001314037 Date of Registration: 21/07/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 23/03/2009
Actual trial start date
Anticipated date of last follow up 31/07/2009
Actual Last follow-up date 31/07/2009
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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
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)
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
Control Group triple ARV therapy standard from booking till 6 weeks post weaning AZT/3TC and Kaletra 250 Active-Treatment of Control Group
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant, HIV positive, booking at Kraaifontein or Durbanville clinics Qualifies for lifelong antiretroviral treatment 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 17/11/2008 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 Commercial Sector/Industry
Primary Sponsor Absolute Return for Kids 37 Hares Ave. Cape Town 7705 South Africa Commercial Sector/Industry
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 Street address
Principal Investigator Ashraf Grimwood agrimwoo@iafrica.com +27828825770 VINE PARK HEALTH & WELLNESS CENTRE, Vine Park Rd, Woodstock,7925
City Postal code Country Position/Affiliation
Cape Town 7705 South Africa Head
Role Name Email Phone Street address
Public Enquiries Nickesh Maharaj nickesh@arkonline.org 27 31 2691167 7 Dodoma Avenue, Clare Estate, 4091
City Postal code Country Position/Affiliation
Durban 4091 South Africa In charge of closing down the trial
Role Name Email Phone Street address
Scientific Enquiries Nickesh Maharaj nickesh@arkonline.org 27 31 2691167 7 Dodoma Avenue, Clare Estate, 4091
City Postal code Country Position/Affiliation
Durban 4091 South Africa In charge of closing down the trial
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