title: Dried blood spots for viral load monitoring in Malawi: feasible and effective.
abstract: OBJECTIVE
  To evaluate the feasibility and effectiveness of dried blood spots (DBS) use for viral load (VL) monitoring, describing patient outcomes and programmatic challenges that are relevant for DBS implementation in sub-Saharan Africa.
  
  
  METHODS
  We recruited adult antiretroviral therapy (ART) patients from five district hospitals in Malawi. Eligibility reflected anticipated Ministry of Health VL monitoring criteria. Testing was conducted at a central laboratory. Virological failure was defined as >5000 copies/ml. Primary outcomes were program feasibility (timely result availability and patient receipt) and effectiveness (second-line therapy initiation).
  
  
  RESULTS
  We enrolled 1,498 participants; 5.9% were failing at baseline. Median time from enrollment to receipt of results was 42 days; 79.6% of participants received results within 3 months. Among participants with confirmed elevated VL, 92.6% initiated second-line therapy; 90.7% were switched within 365 days of VL testing. Nearly one-third (30.8%) of participants with elevated baseline VL had suppressed (<5,000 copies/ml) on confirmatory testing. Median period between enrollment and specimen testing was 23 days. Adjusting for relevant covariates, participants on ART >4 years were more likely to be failing than participants on therapy 1-4 years (RR 1.7, 95% CI 1.0-2.8); older participants were less likely to be failing (RR 0.95, 95% CI 0.92-0.98). There was no difference in likelihood of failure based on clinical symptoms (RR 1.17, 95% CI 0.65-2.11).
  
  
  CONCLUSIONS
  DBS for VL monitoring is feasible and effective in real-world clinical settings. Centralized DBS testing may increase access to VL monitoring in remote settings. Programmatic outcomes are encouraging, especially proportion of eligible participants switched to second-line therapy.
authors.affiliation: Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States; Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Rutstein
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States; University of North Carolina Project, Lilongwe, Malawi.
authors.forename: Mina C
authors.initials: MC
authors.lastname: Hosseinipour
authors.affiliation: University of North Carolina Project, Lilongwe, Malawi.
authors.forename: Deborah
authors.initials: D
authors.lastname: Kamwendo
authors.affiliation: University of North Carolina Project, Lilongwe, Malawi.
authors.forename: Alice
authors.initials: A
authors.lastname: Soko
authors.affiliation: School of Public Health, Loma Linda University, Loma Linda, California, United States.
authors.forename: Memory
authors.initials: M
authors.lastname: Mkandawire
authors.affiliation: Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.
authors.forename: Andrea K
authors.initials: AK
authors.lastname: Biddle
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.
authors.forename: William C
authors.initials: WC
authors.lastname: Miller
authors.affiliation: Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.
authors.forename: Morris
authors.initials: M
authors.lastname: Weinberger
authors.affiliation: Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.
authors.forename: Stephanie B
authors.initials: SB
authors.lastname: Wheeler
authors.affiliation: Centers for Disease Control, Lilongwe, Malawi.
authors.forename: Abdoulaye
authors.initials: A
authors.lastname: Sarr
authors.affiliation: Centers for Disease Control, Lilongwe, Malawi.
authors.forename: Sundeep
authors.initials: S
authors.lastname: Gupta
authors.affiliation: Ministry of Health, Lilongwe, Malawi.
authors.forename: Frank
authors.initials: F
authors.lastname: Chimbwandira
authors.affiliation: Ministry of Health, Lilongwe, Malawi.
authors.forename: Reuben
authors.initials: R
authors.lastname: Mwenda
authors.affiliation: College of Medicine, Blantyre, Malawi.
authors.forename: Steve
authors.initials: S
authors.lastname: Kamiza
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.
authors.forename: Irving
authors.initials: I
authors.lastname: Hoffman
authors.affiliation: School of Public Health, Loma Linda University, Loma Linda, California, United States.
authors.forename: Ronald
authors.initials: R
authors.lastname: Mataya
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D059788:Dried Blood Spot Testing; D016903:Drug Monitoring; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D008295:Malawi; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral / Q000235:genetics* / Q000302:isolation & purification; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral