title: Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam.
abstract: The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam.
  
  
  
  Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends.
  
  
  
  Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2-4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1-8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): -0.9 (-1.5;-0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): -5.7 (-6.3;-5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01].
  
  
  
  There was a low virologic failure risk during the first 2 years of ART follow-up in a rural low-income setting in Vietnam. Peer support did not show any impact on virologic and immunologic outcomes after 2 years of follow up.
  
  
  
  NCT01433601 .
authors.affiliation: Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden. doduy.cuong@gmail.com.|Infectious Diseases Department, Bach Mai Hospital, Hanoi, Vietnam. doduy.cuong@gmail.com.
authors.forename: Do Duy
authors.initials: DD
authors.lastname: Cuong
authors.affiliation: Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.|Division of Clinical Virology, Department of Laboratory Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Sönnerborg
authors.affiliation: Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.|Vietnam-Sweden Uong Bi General Hospital, Quang Ninh, Vietnam.
authors.forename: Vu
authors.initials: V
authors.lastname: Van Tam
authors.affiliation: Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.|World Health Programme, Université du Québec en Abitibi-Témiscamingue (UQAT), Rouyn-Noranda, Canada.
authors.forename: Ziad
authors.initials: Z
authors.lastname: El-Khatib
authors.affiliation: Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Michele
authors.initials: M
authors.lastname: Santacatterina
authors.affiliation: Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Marrone
authors.affiliation: Hanoi Medical University, Hanoi, Vietnam.
authors.forename: Nguyen Thi Kim
authors.initials: NT
authors.lastname: Chuc
authors.affiliation: Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Vinod
authors.initials: V
authors.lastname: Diwan
authors.affiliation: Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Thorson
authors.affiliation: Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
authors.forename: Nicole K
authors.initials: NK
authors.lastname: Le
authors.affiliation: Hanoi Medical University, Hanoi, Vietnam.
authors.forename: Pham Nhat
authors.initials: PN
authors.lastname: An
authors.affiliation: Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden. mattias.larsson@ki.se.|Oxford University Clinical Research Unit (OUCRU), Hanoi, Vietnam. mattias.larsson@ki.se.
authors.forename: Mattias
authors.initials: M
authors.lastname: Larsson
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D016000:Cluster Analysis; D003376:Counseling; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000523:psychology / Q000821:virology*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D019829:Nevirapine / Q000627:therapeutic use*; D010379:Peer Group; D012944:Social Support; D018119:Stavudine / Q000627:therapeutic use*; D016896:Treatment Outcome; D014744:Vietnam / Q000453:epidemiology; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; C516355:stavudine, lamivudine, nevirapine drug combination; D019259:Lamivudine; D019829:Nevirapine; D018119:Stavudine
keywords: Antiretroviral therapy; CD4 count; HIV; Peer support; Vietnam; Virologic failure