title: A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study.
abstract: BACKGROUND
  Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum. Data from "real-life" settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum.
  
  
  METHODS
  We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based, and practical interventions-including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care-as compared to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes. Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test. Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted.
  
  
  CONCLUSIONS
  Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a "real-life" service delivery system in a SSA country severely impacted by HIV.
  
  
  BACKGROUND
  Clinicaltrials.gov, NCT01930084.
authors.affiliation: ICAP, Columbia University, New York, NY, USA. be2124@cumc.columbia.edu.
authors.forename: Batya
authors.initials: B
authors.lastname: Elul
authors.forename: Maria
authors.initials: M
authors.lastname: Lahuerta
authors.forename: Fatima
authors.initials: F
authors.lastname: Abacassamo
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Lamb
authors.forename: Laurence
authors.initials: L
authors.lastname: Ahoua
authors.forename: Margaret L
authors.initials: ML
authors.lastname: McNairy
authors.forename: Maria
authors.initials: M
authors.lastname: Tomo
authors.forename: Deborah
authors.initials: D
authors.lastname: Horowitz
authors.forename: Roberta
authors.initials: R
authors.lastname: Sutton
authors.forename: Antonio
authors.initials: A
authors.lastname: Mussa
authors.forename: Danielle
authors.initials: D
authors.lastname: Gurr
authors.forename: Ilesh
authors.initials: I
authors.lastname: Jani
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D009042:Motivation; D009073:Mozambique; D010349:Patient Compliance; D019095:Point-of-Care Systems; D017010:Reminder Systems; D059039:Standard of Care; D060145:Text Messaging
chemical_list: D019380:Anti-HIV Agents