title: The effect of an interactive weekly mobile phone messaging on retention in prevention of mother to child transmission (PMTCT) of HIV program: study protocol for a randomized controlled trial (WELTEL PMTCT).
abstract: Improving retention in prevention of mother to child transmission (PMTCT) of HIV programs is critical to optimize maternal and infant health outcomes, especially now that lifelong treatment is immediate regardless of CD4 cell count). The WelTel strategy of using weekly short message service (SMS) to engage patients in care in Kenya, where mobile coverage even in poor areas is widespread has been shown to improve adherence to antiretroviral therapy (ART) and viral load suppression among those on ART. The aim of this study is to determine the effect of the WelTel SMS intervention compared to standard care on retention in PMTCT program in Kenya.
  
  
  
  WelTel PMTCT is a four to seven-centers, two-arm open randomized controlled trial (RCT) that will be conducted in urban and rural Kenya. Over 36 months, we plan to recruit 600 pregnant women at their first antenatal care visit and follow the mother-infant pair until they are discharged from the PMTCT program (when infant is aged 24 months). Participants will be randomly allocated to the intervention or control arm (standard care) at a 1:1 ratio. Intervention arm participants will receive an interactive weekly SMS 'How are you?' to which they are supposed to respond within 24 h. Depending on the response (ok, problem or no answer), a PMTCT nurse will follow-up and triage any problems that are identified. The primary outcome will be retention in care defined as the proportion of mother-infant pairs coming for infant HIV testing at 24 months from delivery. Secondary outcomes include a) adherence to WelTel; (b) adherence to antiretroviral medicine; (c) acceptance of WelTel and (d) cost-effectiveness of the WelTel intervention.
  
  
  
  This trial will provide evidence on the effectiveness of mHealth for PMTCT retention. Trial results and the cost-effectiveness evaluation will be used to inform policy and potential scale-up of mHealth among mothers living with HIV.
  
  
  
  ISRCTN98818734 ; registered on 9th December 2014.
authors.affiliation: Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden. Patricia.Awiti@ki.se.
authors.forename: Patricia Opondo
authors.initials: PO
authors.lastname: Awiti
authors.affiliation: Department of Medical Epidemiology and Statistics, Karolinska Institutet, 171 77, Stockholm, Sweden.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Grotta
authors.affiliation: Division of Infectious diseases, University of British Columbia, Vancouver, Canada.|Division of Global Health, University of British Columbia, Vancouver, Canada.|Department of Public Health Sciences, 171 77, Stockholm, Sweden.
authors.forename: Mia
authors.initials: M
authors.lastname: van der Kop
authors.affiliation: Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.
authors.forename: John
authors.initials: J
authors.lastname: Dusabe
authors.affiliation: Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Thorson
authors.affiliation: Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Mwangi
authors.affiliation: Department of Medical Epidemiology and Statistics, Karolinska Institutet, 171 77, Stockholm, Sweden.
authors.forename: Rino
authors.initials: R
authors.lastname: Belloco
authors.affiliation: Department of Medicine, University of British Columbia, Vancouver, Canada.
authors.forename: Richard
authors.initials: R
authors.lastname: Lester
authors.affiliation: Newcastle University, Tyne and Wear, NE1 7RU, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Ternent
authors.affiliation: Department of Reproductive Health, Moi University, P.O.BOX 3900-30100, Eldoret, Kenya.
authors.forename: Edwin
authors.initials: E
authors.lastname: Were
authors.affiliation: Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.
authors.forename: Anna Mia
authors.initials: AM
authors.lastname: Ekström
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007630:Kenya; D055118:Medication Adherence; D017216:Telemedicine / Q000379:methods*; D060145:Text Messaging; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents
keywords: Antiretroviral therapy (ART); HIV/PMTCT; Kenya; Mobile health (m-health); Retention