title: Improving PMTCT uptake and retention services through novel approaches in peer-based family-supported care in the clinic and community: a 3-arm cluster randomized trial (PURE Malawi).
abstract: In July 2011, Malawi introduced an ambitious public health program known as "Option B+," which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of clinical stage or CD4 count. Option B+ is expected to have benefits for HIV-infected women, their HIV-exposed infants, and their HIV-uninfected male sex partners. However, these benefits hinge on early uptake of prevention of mother-to-child transmission, good adherence, and long-term retention in care. The Prevention of mother-to-child transmission Uptake and REtention (PURE) study is a 3-arm cluster randomized controlled trial to evaluate whether clinic- or community-based peer support will improve care-seeking and retention in care by HIV-infected pregnant and breastfeeding women, their HIV-exposed infants, and their male sex partners, and ultimately improve health outcomes in all 3 populations. We describe the PURE Malawi Consortium, the initial work conducted to inform the trial and interventions, the trial design, and the analysis plan. We then discuss concerns and expected contributions to Malawi and the region.
authors.affiliation: *University of North Carolina Project, Lilongwe, Malawi; †Dignitas International, Zomba, Malawi; ‡Dalla Lana School of Public Health, University of Toronto, Toronto, Canada; §Lighthouse Trust, Lilongwe, Malawi; ‖The International Union Against Tuberculosis and Lung Disease, Paris, France; ¶University of Malawi College of Medicine, Blantyre, Malawi; #University of Malawi Chancellor College, Zomba, Malawi; **Mothers2Mothers, Lilongwe, Malawi; ††Management Sciences for Health, Lilongwe, Malawi; and ‡‡Ministry of Health, Lilongwe, Malawi.
authors.forename: Nora E
authors.initials: NE
authors.lastname: Rosenberg
authors.forename: Monique
authors.initials: M
authors.lastname: van Lettow
authors.forename: Hannock
authors.initials: H
authors.lastname: Tweya
authors.forename: Atupele
authors.initials: A
authors.lastname: Kapito-Tembo
authors.forename: Cassandre Man
authors.initials: CM
authors.lastname: Bourdon
authors.forename: Fabian
authors.initials: F
authors.lastname: Cataldo
authors.forename: Levison
authors.initials: L
authors.lastname: Chiwaula
authors.forename: Veena
authors.initials: V
authors.lastname: Sampathkumar
authors.forename: Clement
authors.initials: C
authors.lastname: Trapence
authors.forename: Virginia
authors.initials: V
authors.lastname: Kayoyo
authors.forename: Florence
authors.initials: F
authors.lastname: Kasende
authors.forename: Blessings
authors.initials: B
authors.lastname: Kaunda
authors.forename: Colin
authors.initials: C
authors.lastname: Speight
authors.forename: Erik
authors.initials: E
authors.lastname: Schouten
authors.forename: Michael
authors.initials: M
authors.lastname: Eliya
authors.forename: Mina
authors.initials: M
authors.lastname: Hosseinipour
authors.forename: Sam
authors.initials: S
authors.lastname: Phiri
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use; D005190:Family; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000517:prevention & control / Q000635:transmission*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008295:Malawi; D010349:Patient Compliance; D010379:Peer Group; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000517:prevention & control*; D018401:Sample Size
chemical_list: D019380:Anti-HIV Agents