title: The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania.
abstract: Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) may improve ART retention by reducing the time burden and out-of-pocket expenditures to regularly attend an ART clinic. In addition, ART home delivery may shorten waiting times and improve quality of care for those in facility-based care by decongesting ART clinics. This trial aims to determine whether ART home delivery for patients who are clinically stable on ART combined with facility-based care for those who are not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression.
  
  
  
  This is a non-inferiority cluster-randomized trial set in Dar es Salaam, Tanzania. A cluster is one of 48 healthcare facilities with its surrounding catchment area. 24 clusters were randomized to ART home delivery and 24 to the standard of care. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART and CHW home visits without ART home delivery). In addition, half of the healthcare facilities in each study arm were randomized to standard counseling during home visits (covering family planning, prevention of HIV transmission, and ART adherence), and half to standard plus nutrition counseling (covering food production and dietary advice). The non-inferiority design applies to the endpoints of the ART home delivery trial; the primary endpoint is the proportion of ART patients at a healthcare facility who are virally suppressed at the end of the study period. The margin of non-inferiority for this primary endpoint was set at nine percentage points.
  
  
  
  As the number of ART patients in sub-Saharan Africa is expected to rise, this trial provides causal evidence on the effectiveness of a home-based care model that could decongest ART clinics and reduce patients' healthcare expenditures. More broadly, this trial will inform the increasing policy interest in task-shifting of chronic disease care from facility- to community-based healthcare workers.
  
  
  
  ClinicalTrials.gov: NCT02711293 . Registration date: 16 March 2016.
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.
authors.forename: Pascal
authors.identifier: 0000-0002-8878-5505
authors.initials: P
authors.lastname: Geldsetzer
authors.affiliation: Management and Development for Health, Plot #802, Mwai Kibaki Road, Mikocheni, Dar es Salaam, Tanzania. joelmfrancis@gmail.com.|Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA. joelmfrancis@gmail.com.|National Institute for Medical Research, 3 Barack Obama Drive, 11101, Dar es Salaam, Tanzania. joelmfrancis@gmail.com.
authors.forename: Joel M
authors.initials: JM
authors.lastname: Francis
authors.affiliation: Management and Development for Health, Plot #802, Mwai Kibaki Road, Mikocheni, Dar es Salaam, Tanzania.
authors.forename: Nzovu
authors.initials: N
authors.lastname: Ulenga
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.
authors.forename: David
authors.initials: D
authors.lastname: Sando
authors.affiliation: Management and Development for Health, Plot #802, Mwai Kibaki Road, Mikocheni, Dar es Salaam, Tanzania.
authors.forename: Irene A
authors.initials: IA
authors.lastname: Lema
authors.affiliation: Management and Development for Health, Plot #802, Mwai Kibaki Road, Mikocheni, Dar es Salaam, Tanzania.
authors.forename: Eric
authors.initials: E
authors.lastname: Mboggo
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Vaikath
authors.affiliation: Management and Development for Health, Plot #802, Mwai Kibaki Road, Mikocheni, Dar es Salaam, Tanzania.
authors.forename: Happiness
authors.initials: H
authors.lastname: Koda
authors.affiliation: National AIDS Control Program, Lithuli Street, P.O. Box 11857, Dar es Salaam, Tanzania.
authors.forename: Sharon
authors.initials: S
authors.lastname: Lwezaula
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.|Duke University School of Medicine, Duke University, 8 Duke University Medical Center Greenspace, Durham, NC, 27703, USA.
authors.forename: Janice
authors.initials: J
authors.lastname: Hu
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.|Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA.|Africa Academy for Public Health (AAPH), Plot #802, Mwai Kibaki Road, Dar es Salaam, Tanzania.
authors.forename: Ramadhani A
authors.initials: RA
authors.lastname: Noor
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.
authors.forename: Ibironke
authors.initials: I
authors.lastname: Olofin
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.
authors.forename: Elysia
authors.initials: E
authors.lastname: Larson
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.|Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA.|Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA.
authors.forename: Wafaie
authors.initials: W
authors.lastname: Fawzi
authors.affiliation: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.|Institute for Public Health, Faculty of Medicine, Heidelberg University, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.|Africa Health Research Institute, Mtubatuba 3935, KwaZulu-Natal, South Africa.
authors.forename: Till
authors.initials: T
authors.lastname: Bärnighausen
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D016000:Cluster Analysis; D003153:Community Health Services / Q000458:organization & administration* / Q000592:standards; D003150:Community Health Workers / Q000458:organization & administration* / Q000592:standards; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control / Q000821:virology*; D006266:Health Education / Q000458:organization & administration* / Q000592:standards; D007722:Health Knowledge, Attitudes, Practice; D006302:Health Services Research; D006801:Humans; D010342:Patient Acceptance of Health Care; D012107:Research Design; D013636:Tanzania
chemical_list: D019380:Anti-HIV Agents
keywords: Adherence; Antiretroviral therapy; Community health workers; Food production; HIV; Healthcare expenditure; Nutrition counseling; Retention