Strategies to Optimize Antiretroviral Therapy Services for Maternal & Child Health: the MCH-ART Study (MCH-ART)
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ClinicalTrials.gov Identifier: NCT01933477 |
Recruitment Status : Unknown
Verified July 2016 by Associate Professor Landon Myer, University of Cape Town.
Recruitment status was: Active, not recruiting
First Posted : September 2, 2013
Last Update Posted : July 6, 2016
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Condition or disease | Intervention/treatment | Phase |
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HIV | Other: MCH-focused ART services | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1554 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Health Services Research |
Official Title: | Strategies to Optimize Antiretroviral Therapy Services for Maternal & Child Health: the MCH-ART Study |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | July 2016 |
Estimated Study Completion Date : | March 2017 |

Arm | Intervention/treatment |
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No Intervention: Local Standard of Care
Arm A: Referral of post-partum women from the antenatal clinic to general adult ART services at approximately 4-8 weeks postpartum (the local current standard of care in this setting)
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Active Comparator: MCH-focused ART services
Arm B: Continued receipt of MCH-focused ART services based at the antenatal clinic throughout the period of breastfeeding. Post-partum women will only be referred to general adult ART services after the end of breastfeeding and once infants' final HIV status is determined.
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Other: MCH-focused ART services
Post-partum women who are breast feeding will be retained in the antenatal clinic to receive continued MCH-focused ART services until after the end of breastfeeding and once infants' final HIV status is determined. |
- Combined endpoint of (i) maternal HIV viral suppression, and (ii) maternal retention in ART services, at 12 months postpartum [ Time Frame: Up to one year post partum follow-up for all phase 3 participants ]
- Maternal retention in care up to 12 months postpartum [ Time Frame: Up to one year post-partum ]
- Maternal viral suppression throughout the breastfeeding period as well as before and after cessation of breastfeeding [ Time Frame: Up to one year post partum ]
- Rates of HIV transmission from mother-to-child at 6 weeks and up to 12 months postpartum [ Time Frame: Up to one year post partum ]
- Breastfeeding practices, including duration of exclusive feeding and weaning patterns [ Time Frame: Up to one year post partum ]
- Acceptability of different strategies for delivering HIV care and treatment during the postpartum period [ Time Frame: Up to one year post partum ]
- Subgroup analyses of the primary outcome according to participant demographic characteristics, medical history, clinical characteristics and psychosocial characteristics [ Time Frame: up to 12 months postpartum ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
- 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 CD4 count and/or WHO staging according to public sector testing or assessment
- Not currently using triple-drug antiretroviral therapy (women started on AZT for PMTCT during the current pregnancy are eligible) or have not used ART within the previous 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 #
Exclusion Criteria:
Individuals meeting any of the following exclusion criteria at the point in the study will be excluded:
- 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)
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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:
- Refusal to take ART/ARVs
- Denial of HIV status

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933477
South Africa | |
Gugulethu Midwife Obstetric Unit | |
Cape Town, Western Cape, South Africa |
Principal Investigator: | Landon Myer, MBChB, PhD | University of Cape Town | |
Principal Investigator: | Elaine J Abrams, MD | Columbia University |
Responsible Party: | Associate Professor Landon Myer, Professor, University of Cape Town |
ClinicalTrials.gov Identifier: | NCT01933477 |
Other Study ID Numbers: |
Acct#5-30539 |
First Posted: | September 2, 2013 Key Record Dates |
Last Update Posted: | July 6, 2016 |
Last Verified: | July 2016 |
Maternal Health Child Health HIV infection Antenatal care |
Postpartum care Prevention of mother to child transmission (PMTCT) Breast feeding Antiretrovirals |