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.: PACTR201411000884278 Date of Approval: 11/09/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Strategies to optimize antiretroviral therapy services for maternal & child health: the MCH-ART study
Official scientific title Strategies to optimize antiretroviral therapy services for maternal & child health: the MCH-ART study
Brief summary describing the background and objectives of the trial Strategies to optimize antiretroviral therapy services for maternal & child health: the MCH-ART study
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MCHART
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 01/04/2013
Actual trial start date 01/04/2013
Anticipated date of last follow up 15/11/2015
Actual Last follow-up date 15/11/2015
Anticipated target sample size (number of participants) 1600
Actual target sample size (number of participants) 480
Recruitment status 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 Randomization follows a dynamic permuted block design Randomization envelopes are stored in a locked cabinet in the study office Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Randomization follows a dynamic permuted block design Randomization envelopes are stored in a locked cabinet in the study office Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Arm A Routine postpartum care 12 months referral to general adult ART services from approximately 4-8 weeks postpartum (the local standard of care) 240 Active-Treatment of Control Group
Experimental Group Arm B Routine postpartum care up to 12 months or until breastfeeding cessation Receipt of ART in the antenatal clinic, as part of a MCH-focused ART service that only refers women to general adult ART services after the end of breastfeeding and once infants¿ final HIV status is determined 240
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Phase 1 Age 18 years or older Documented HIV-infection according to two finger-prick rapid tests using different test types (per routine protocol in this setting) or documentation of HIV status for those women self reporting HIV diagnosis. Confirmed pregnancy according to urine pregnancy test, ultrasound or clinical assessment Has not initiated triple-drug antiretroviral therapy or AZT for PMTCT during the current pregnancy Able to provide informed consent for research (Informed Consent #1) Phase 2: Subset of Phase 1 participants who are ART-eligible Consented and participated in Phase 1 Documented ART eligibility based on current local guidelines Started or scheduled to start ART at Gugulethu MOU in the current pregnancy (women started on AZT for PMTCT during the current pregnancy are eligible) Women who were previously receiving lifelong ART must have not used ART for at least 6 months. Able to provide informed consent for research (Informed Consent #2) Phase 3: Subset of Phase 2 participants eligible for randomization Consented and participated in Phase 2 Initiated ART during the antenatal period Currently breastfeeding within <7 days postpartum (with an allowable window of up to 28 days postpartum) Willingness to be randomized and return for postnatal study visits Able to provide informed consent for research (Informed Consent #3) Not currently pregnant (Phases 1 and 2) or loss of pregnancy/neonate (Phase 3) at the time of eligibility determination Intention to relocate out of Cape Town permanently during the study period (Phase 2 and 3 only) Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study (all phases), including: o Refusal to take ART/ARVs o Denial of HIV status 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 24/10/2012 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Rm E52-24 Groote Schuur Hospital, Old Main Building Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare an MCH-focused ART service to general adult ART services as strategies for providing ART during the postpartum period on (i) maternal HIV viral suppression, and (ii) maternal retention in ART services, at 12 months postpartum. First antenatal visit Second Antenatal visit Late third trimester visit Less than 7 days postpartum 3 months 6 months 9 months 12 months
Secondary Outcome To characterize the health status of the population of HIV+ pregnant women seeking antenatal care at the Gugulethu Midwife Obstetric Unit (MOU) including maternal and infant outcomes First antenatal visit Second Antenatal visit Late third trimester visit Less than 7 days postpartum 3 months 6 months 9 months 12 months
Secondary Outcome To describe uptake and timing of services received throughout the PMTCT cascade, including antenatal ART initiation and follow-up, at the Gugulethu MOU First antenatal visit Second Antenatal visit Late third trimester visit Less than 7 days postpartum 3 months 6 months 9 months 12 months
Secondary Outcome To describe changes in women¿s clinical and/or psychosocial characteristics between the antenatal and postnatal periods, and investigate how these are independently associated with the primary outcome First antenatal visit Second Antenatal visit Late third trimester visit Less than 7 days postpartum 3 months 6 months 9 months 12 months
Secondary Outcome To compare MCH-focused ART services to general adult ART services on: First antenatal visit Second Antenatal visit Late third trimester visit Less than 7 days postpartum 3 months 6 months 9 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gugulethu Midwife Obstetric Unit (MOU) Corner NY3 AND NY77, Gugulethu Cape Town s/a South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 6700B Rockledge Drive Betheseda 20892 7616 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Columbia University 722 West 168th Street New York NY10032 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Prof Elaine Abrams ICAP, Mailman School of Public Health New York NY10032 United States of America
A/Prof Landon Myer School of Public Health and Family Medicine, Univeristy of Cape Town Cape Town 7925 South Africa
A/Prof Linda-Gail Bekker Desmond Tutu HIV Foundation, University of Cape Town Cape Town South Africa
Ms Allison Zerbe ICAP, Mailman School of Public Health, Columbia University New York United States of America
Dr Greg Petro Metro-West Director: O&G, Provincial Government of the Western Cape Cape Town South Africa
Dr David Pienaar HAST Directorate, Provincial Government of the Western Cape Cape Town South Africa
A/Prof Francesca Little Department of Statistical Sciences, University of Cape Town Cape Town South Africa
Prof Heather Zar Department of Paediatrics & Child Health, University of Cape Town, Red Cross War Memorial Children¿s Hospital Cape Town South Africa
Prof James McIntyre Anova Health Institute & School of Public, Health & Family Medicine, University of Cape Town Cape Town South Africa
Prof Robert Remien HIV Centre for Clinical & Behavioural Studies, New York State Psychiatric Institute, Columbia University New York United States of America
Prof Claude Mellins HIV Centre for Clinical & Behavioural Studies, New York State Psychiatric Institute, Columbia University New York United States of America
Dr Catherine Orrell Desmond Tutu HIV Centre, IIDMM, University of Cape Town Cape Town South Africa
A/Prof Linda-Gail Bekker Desmond Tutu HIV Foundation, University of Cape Town Cape Town South Africa
Ms Allison Zerbe ICAP, Mailman School of Public Health, Columbia University New York United States of America
Dr Greg Petro Metro-West Director: O&G, Provincial Government of the Western Cape Cape Town South Africa
Dr David Pienaar HAST Directorate, Provincial Government of the Western Cape Cape Town South Africa
A/Prof Francesca Little Department of Statistical Sciences, University of Cape Town Cape Town South Africa
Prof Heather Zar Department of Paediatrics & Child Health, University of Cape Town, Red Cross War Memorial Children¿s Hospital Cape Town South Africa
Prof James McIntyre Anova Health Institute & School of Public, Health & Family Medicine, University of Cape Town Cape Town South Africa
Prof Robert Remien HIV Centre for Clinical & Behavioural Studies, New York State Psychiatric Institute, Columbia University New York United States of America
Prof Claude Mellins HIV Centre for Clinical & Behavioural Studies, New York State Psychiatric Institute, Columbia University New York United States of America
Dr Catherine Orrell Desmond Tutu HIV Centre, IIDMM, University of Cape Town Cape Town South Africa
A/Prof Linda-Gail Bekker Desmond Tutu HIV Foundation, University of Cape Town Cape Town South Africa
Ms Allison Zerbe ICAP, Mailman School of Public Health, Columbia University New York United States of America
Dr Greg Petro Metro-West Director: O&G, Provincial Government of the Western Cape Cape Town South Africa
Dr David Pienaar HAST Directorate, Provincial Government of the Western Cape Cape Town South Africa
A/Prof Francesca Little Department of Statistical Sciences, University of Cape Town Cape Town South Africa
Prof Heather Zar Department of Paediatrics & Child Health, University of Cape Town, Red Cross War Memorial Children¿s Hospital Cape Town South Africa
Prof James McIntyre Anova Health Institute & School of Public, Health & Family Medicine, University of Cape Town Cape Town South Africa
Prof Robert Remien HIV Centre for Clinical & Behavioural Studies, New York State Psychiatric Institute, Columbia University New York United States of America
Prof Claude Mellins HIV Centre for Clinical & Behavioural Studies, New York State Psychiatric Institute, Columbia University New York United States of America
Dr Catherine Orrell Desmond Tutu HIV Centre, IIDMM, University of Cape Town Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Landon Myer landon.myer@uct.ac.za +27216506661 School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7925 United States of America Principal Investigator
Role Name Email Phone Street address
Public Enquiries Tammy Phillips tamsinkatephillips@gmail.com +27216506713 School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Project Coordinator
Role Name Email Phone Street address
Scientific Enquiries Landon Myer landon.myer@uct.ac.za +27216506661 School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Principal Investigator
REPORTING
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