title: Optimizing Antiretroviral Therapy (ART) for Maternal and Child Health (MCH): Rationale and Design of the MCH-ART Study.
abstract: Prevention of mother-to-child transmission of HIV implementation faces significant challenges globally, particularly in the context of universal lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women.
  
  
  
  We describe the rationale and methods of the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) study, an implementation science project examining strategies for providing HIV care and treatment to HIV-infected women who initiate ART during pregnancy and their HIV-exposed infants.
  
  
  
  MCH-ART is composed of 3 interrelated study designs across the antenatal and postnatal periods. Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women seeking antenatal care; phase 2 is an observational cohort of all women from phase 1 who are eligible for initiation of ART following local guidelines; and phase 3 is a randomized trial of strategies for delivering ART to breastfeeding women from phase 2 during the postpartum period. During each phase, a set of study measurement visits is carried out separately from antenatal care and ART services; a maximum of 9 visits takes place from the beginning of antenatal care through 12 months postpartum. In parallel, in-depth interviews are used to examine issues of ART adherence and retention qualitatively, and costs and cost-effectiveness of models of care are examined. Separate substudies examine health outcomes in HIV-uninfected women and their HIV-unexposed infants, and the role of the adherence club model for long-term adherence and retention.
  
  
  
  Combining observational and experimental components, the MCH-ART study presents a novel approach to understand and optimize ART delivery for MCH.
authors.affiliation: *Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa; †Centre for Infectious Diseases Epidemiology & Research, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa; ‡ICAP, Columbia University Mailman School of Public Health, New York, NY; §National Health Laboratory Services, Groote Schuur Hospital & Division of Medical Virology, University of Cape Town, Cape Town, South Africa; ‖HIV Center for Clinical & Behavioral Studies, New York State Psychiatric Institute and Columbia University, New York, NY; ¶Division of Infectious Diseases, Department of Medicine, Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA; #Department of Obstetrics & Gynaecology, New Somerset Hospital, University of Cape Town, Cape Town, South Africa; **Anova Health Institute, Johannesburg, South Africa; and ††College of Physicians & Surgeons, Columbia University, New York, NY.
authors.forename: Landon
authors.initials: L
authors.lastname: Myer
authors.forename: Tamsin K
authors.initials: TK
authors.lastname: Phillips
authors.forename: Allison
authors.initials: A
authors.lastname: Zerbe
authors.forename: Agnes
authors.initials: A
authors.lastname: Ronan
authors.forename: Nei-Yuan
authors.initials: NY
authors.lastname: Hsiao
authors.forename: Claude A
authors.initials: CA
authors.lastname: Mellins
authors.forename: Robert H
authors.initials: RH
authors.lastname: Remien
authors.forename: Stanzi M
authors.initials: SM
authors.lastname: Le Roux
authors.forename: Kirsty
authors.initials: K
authors.lastname: Brittain
authors.forename: Andrea
authors.initials: A
authors.lastname: Ciaranello
authors.forename: Greg
authors.initials: G
authors.lastname: Petro
authors.forename: James A
authors.initials: JA
authors.lastname: McIntyre
authors.forename: Elaine J
authors.initials: EJ
authors.lastname: Abrams
mesh_terms: D017954:Africa South of the Sahara; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001942:Breast Feeding; D000068456:Clinical Studies as Topic; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D010349:Patient Compliance; D049590:Postpartum Period; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*
chemical_list: D019380:Anti-HIV Agents