title: Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial.
abstract: OBJECTIVE
  Self-testing for HIV infection may contribute to early diagnosis of HIV, but without necessarily increasing antiretroviral therapy (ART) initiation.
  
  
  OBJECTIVE
  To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase demand for ART initiation, compared with HIV self-testing accompanied by facility-based services only.
  
  
  METHODS
  Cluster randomized trial conducted in Blantyre, Malawi, between January 30 and November 5, 2012, using restricted 1:1 randomization of 14 community health worker catchment areas. Participants were all adult (≥16 years) residents (n = 16,660) who received access to home HIV self-testing through resident volunteers. This was a second-stage randomization of clusters allocated to the HIV self-testing group of a parent trial.
  
  
  METHODS
  Clusters were randomly allocated to facility-based care or optional home initiation of HIV care (including 2 weeks of ART if eligible) for participants reporting positive HIV self-test results.
  
  
  METHODS
  The preplanned primary outcome compared between groups the proportion of all adult residents who initiated ART within the first 6 months of HIV self-testing availability. Secondary outcomes were uptake of HIV self-testing, reporting of positive HIV self-test results, and rates of loss from ART at 6 months.
  
  
  RESULTS
  A significantly greater proportion of adults in the home group initiated ART (181/8194, 2.2%) compared with the facility group (63/8466, 0.7%; risk ratio [RR], 2.94, 95% CI, 2.10-4.12; P < .001). Uptake of HIV self-testing was high in both the home (5287/8194, 64.9%) and facility groups (4433/8466, 52.7%; RR, 1.23; 95% CI, 0.96-1.58; P = .10). Significantly more adults reported positive HIV self-test results in the home group (490/8194 [6.0%] vs the facility group, 278/8466 [3.3%]; RR, 1.86; 95% CI, 1.16-2.97; P = .006). After 6 months, 52 of 181 ART initiators (28.7%) and 15 of 63 ART initiators (23.8%) in the home and facility groups, respectively, were lost from ART (adjusted incidence rate ratio, 1.18; 95% CI, 0.62-2.25, P = .57).
  
  
  CONCLUSIONS
  Among Malawian adults offered HIV self-testing, optional home initiation of care compared with standard HIV care resulted in a significant increase in the proportion of adults initiating ART.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01414413.
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, United Kingdom2TB and HIV Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
authors.forename: Peter
authors.initials: P
authors.lastname: MacPherson
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, United Kingdom.
authors.forename: David G
authors.initials: DG
authors.lastname: Lalloo
authors.affiliation: MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Emily L
authors.initials: EL
authors.lastname: Webb
authors.affiliation: TB and HIV Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi4Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, United Kingdom.
authors.forename: Hendramoorthy
authors.initials: H
authors.lastname: Maheswaran
authors.affiliation: TB and HIV Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
authors.forename: Augustine T
authors.initials: AT
authors.lastname: Choko
authors.affiliation: HIV Department, Ministry of Health, Lilongwe, Malawi.
authors.forename: Simon D
authors.initials: SD
authors.lastname: Makombe
authors.affiliation: Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Anthony E
authors.initials: AE
authors.lastname: Butterworth
authors.affiliation: Department of Medicine, College of Medicine, University of Malawi, Blantyre, Malawi8Dignitas International, Zomba, Malawi.
authors.forename: Joep J
authors.initials: JJ
authors.lastname: van Oosterhout
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, United Kingdom2TB and HIV Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
authors.forename: Nicola
authors.initials: N
authors.lastname: Desmond
authors.affiliation: TB and HIV Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
authors.forename: Deus
authors.initials: D
authors.lastname: Thindwa
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, United Kingdom.
authors.forename: Stephen Bertel
authors.initials: SB
authors.lastname: Squire
authors.affiliation: MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hayes
authors.affiliation: TB and HIV Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi6Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Elizabeth L
authors.initials: EL
authors.lastname: Corbett
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy*; D006679:HIV Seropositivity; D006699:Home Care Services; D006801:Humans; D008295:Malawi; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D010349:Patient Compliance; D012648:Self Care; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents