title: Does provision of point-of-care CD4 technology and early knowledge of CD4 levels affect early initiation and retention on antiretroviral treatment in HIV-positive pregnant women in the context of Option B+ for PMTCT?
abstract: Evidence for Elimination (E4E) is a collaborative project established in 2012 as part of the INSPIRE (INtegrating and Scaling up PMTCT through Implementation REsearch) initiative. E4E is a cluster-randomized trial with 2 arms; Standard of care and "POC Plus" [in which point-of-care (POC) CD4 devices and related counseling support are provided]; aimed at improving retention-in-care of HIV-infected pregnant women and mothers. In November 2013, Zimbabwe adopted Option B+ for HIV-positive pregnant women under which antiretroviral treatment eligibility is no longer based on CD4 count. However, Ministry of Health and Child Care guidelines still require baseline and 6-monthly CD4 testing for treatment monitoring, until viral load testing becomes widely available. Considering the current limited capacity for viral-load testing, the significant investments in CD4 testing already made and the historical reliance on CD4 by health care workers for determining eligibility for antiretroviral treatment, E4E seeks to compare the impact of the provision of POC CD4 technology and early knowledge of CD4 levels on retention-in-care at 12 months, with the current standard of routine, laboratory-based CD4 testing. The study also compares rates of initiation and time-to-initiation between the 2 arms and according to level of maternal CD4 count, the cost of retaining HIV-positive pregnant women in care and the acceptability and feasibility of POC CD4 in the context of Option B+. Outcome measures are derived from routine health systems data. E4E will provide data on POC CD4 testing and retention-in-care associated with Option B+ and serve as an early learning platform to inform implementation of Option B+ in Zimbabwe.
authors.affiliation: *Clinton Health Access Initiative, Harare, Zimbabwe; †Ministry of Health and Child Care, Harare, Zimbabwe; and ‡University of Zimbabwe, Harare, Zimbabwe.
authors.forename: Alexio-Zambezi
authors.initials: AZ
authors.lastname: Mangwiro
authors.forename: Kudzai
authors.initials: K
authors.lastname: Makomva
authors.forename: Antoinette
authors.initials: A
authors.lastname: Bhattacharya
authors.forename: Gaurav
authors.initials: G
authors.lastname: Bhattacharya
authors.forename: Tendai
authors.initials: T
authors.lastname: Gotora
authors.forename: Mila
authors.initials: M
authors.lastname: Owen
authors.forename: Angela
authors.initials: A
authors.lastname: Mushavi
authors.forename: Douglas
authors.initials: D
authors.lastname: Mangwanya
authors.forename: Sekesai
authors.initials: S
authors.lastname: Zinyowera
authors.forename: Simbarashe
authors.initials: S
authors.lastname: Rusakaniko
authors.forename: Owen
authors.initials: O
authors.lastname: Mugurungi
authors.forename: Simukai
authors.initials: S
authors.lastname: Zizhou
authors.forename: William
authors.initials: W
authors.lastname: Busumani
authors.forename: Nyasha
authors.initials: N
authors.lastname: Masuka
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000635:transmission; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D010349:Patient Compliance; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000517:prevention & control; D018401:Sample Size
chemical_list: D019380:Anti-HIV Agents