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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 : Active, not recruiting
First Posted : September 2, 2013
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Associate Professor Landon Myer, University of Cape Town

Study Description
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Brief Summary:
The purpose of this study is to understand how to improve health care services for HIV-positive women during their pregnancy and after delivery. The study's aim is to compare two different ways of providing antiretroviral therapy for pregnant women with HIV. The study is to be conducted at the Gugulethu Midwife Obstetric Unit (MOU) in Cape Town. There are three phases of the study: Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women attending their first antenatal clinic visit (n=1600); Phase 2 is an observational cohort that will follow women from Phase 1 who are eligible for ART (n=600) from the second antenatal clinic visit until the first postpartum visit; Phase 3 is a randomized trial of women from Phase 2 who are breastfeeding and will compare two different service models for delivering ART to women after they delivery their babies (n=480). For Phase 3, women who are taking ART will randomly be assigned to either (1) referral to receive ART at the nearest adult clinic at 4-8 weeks after delivery (this is currently how all women receive care in this setting) or (2) to continue to come to the antenatal clinic for ART services until the end of breastfeeding. All women will received the standard local ART services (with identical medications and medical treatment); they are different because some women will stay longer in care at the antenatal clinic. All women participating in Phase 3 will be followed through at least 2 months after they deliver.

Condition or disease Intervention/treatment Phase
HIV Other: MCH-focused ART services Not Applicable

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Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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)
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Maternal retention in care up to 12 months postpartum [ Time Frame: Up to one year post-partum ]
  2. Maternal viral suppression throughout the breastfeeding period as well as before and after cessation of breastfeeding [ Time Frame: Up to one year post partum ]
  3. 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 ]
  4. Breastfeeding practices, including duration of exclusive feeding and weaning patterns [ Time Frame: Up to one year post partum ]
  5. Acceptability of different strategies for delivering HIV care and treatment during the postpartum period [ Time Frame: Up to one year post partum ]

Other Outcome Measures:
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
South Africa
Gugulethu Midwife Obstetric Unit
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
University of Cape Town
Columbia University
Investigators
Principal Investigator: Landon Myer, MBChB, PhD University of Cape Town
Principal Investigator: Elaine J Abrams, MD Columbia University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Associate Professor Landon Myer, Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT01933477     History of Changes
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

Keywords provided by Associate Professor Landon Myer, University of Cape Town:
Maternal Health
Child Health
HIV infection
Antenatal care
 Postpartum care
Prevention of mother to child transmission (PMTCT)
Breast feeding
Antiretrovirals