Strategies to Optimize Antiretroviral Therapy Services for Maternal & Child Health: the MCH-ART Study - Full Text View

Purpose

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	Intervention
HIV	Other: MCH-focused ART services


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Health Services Research
Official Title:	Strategies to Optimize Antiretroviral Therapy Services for Maternal & Child Health: the MCH-ART Study

Resource links provided by NLM:

MedlinePlus related topics: Breastfeeding Children's Health HIV/AIDS Postpartum Care

U.S. FDA Resources

Further study details as provided by University of Cape Town:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maternal retention in care up to 12 months postpartum [ Time Frame: Up to one year post-partum ] [ Designated as safety issue: No ]
Maternal viral suppression throughout the breastfeeding period as well as before and after cessation of breastfeeding [ Time Frame: Up to one year post partum ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Breastfeeding practices, including duration of exclusive feeding and weaning patterns [ Time Frame: Up to one year post partum ] [ Designated as safety issue: No ]
Acceptability of different strategies for delivering HIV care and treatment during the postpartum period [ Time Frame: Up to one year post partum ] [ Designated as safety issue: No ]

Other Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	1554
Study Start Date:	March 2013
Estimated Study Completion Date:	March 2017
Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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
Study First Received:	August 22, 2013
Last Updated:	July 5, 2016
Health Authority:	South Africa: Department of Health South Africa: Human Research Ethics Committee

Keywords provided by University of Cape Town:


Maternal Health Child Health HIV infection Antenatal care	Postpartum care Prevention of mother to child transmission (PMTCT) Breast feeding Antiretrovirals

ClinicalTrials.gov processed this record on September 27, 2016

Strategies to Optimize Antiretroviral Therapy Services for Maternal & Child Health: the MCH-ART Study (MCH-ART)