title: Adherence to Early Antiretroviral Therapy: Results From HPTN 052, a Phase III, Multinational Randomized Trial of ART to Prevent HIV-1 Sexual Transmission in Serodiscordant Couples.
abstract: BACKGROUND
  Combination antiretroviral therapy (ART) for HIV-1-infected individuals prevents sexual transmission if viral load is suppressed.
  
  
  METHODS
  Participants were HIV-1-infected partners randomized to early ART (CD4 350-550) in HPTN052 (n = 886, median follow-up = 2.1 years), a clinical trial of early ART to prevent sexual transmission of HIV-1 in serodiscordant couples at 13 sites in 9 countries. Adherence was assessed through pill count (dichotomized at <95%) and through self-report items. Predictors of adherence were mental health and general health perceptions, substance use, binge drinking, social support, sexual behaviors, and demographics. Viral suppression was defined as HIV plasma viral load <400 copies per milliliter. Adherence counseling and couples' counseling about safer sex were provided. Logistic and linear regression models using generalized estimating equation for repeated measurements were used.
  
  
  RESULTS
  Through pill count, 82% of participants were adherent at 1 month and 83.3% at 1 year. Mental health was the only psychosocial variable associated with adherence [pill count, odds ratios (OR) = 1.05, 95% confidence intervals (CIs): 1.00 to 1.11; self-report parameter estimate, OR = 0.02, 95% CI: 0.01 to 0.04], although regional differences emerged. Pill count (OR = 1.19, 95% CI: 1.10 to 1.30) and self-report (OR = 1.42, 95% CI: 1.14 to 1.77) adherence were associated with viral suppression.
  
  
  CONCLUSIONS
  Although adherence was high among individuals in stable relationships taking ART for prevention, mental health and adherence covaried. Assessing and intervening on mental health in the context of promoting adherence to ART as prevention should be explored. Adherence and couples' counseling, feedback about viral suppression, and/or altruism may also help explain the magnitude of adherence observed.
authors.affiliation: *Department of Psychiatry, Massachusetts General Hospital, Boston, MA; †Department of Medicine, Harvard Medical School, Boston, MA; ‡Department of Medicine, Fenway Health, Boston, MA; §Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA; ‖Vaccine and Infectious Disease Division, Statistical Center for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ¶Science Facilitation Department, FHI 360, Washington, DC; #HIV/AIDS Clinical Trials Unit, Instituto de Pesquisa Clinica Evandro Chagas, Rio de Janeiro, Brazil; **Division of Infectious Diseases, University of North Carolina at Chapel Hill, Institute for Global Health and Infectious Diseases, Lilongwe, Malawi; ††CART CRS, YRGCARE Medical Centre, YRG CARE Medical Center, VHS Chennai CRS, Chennai, India; ‡‡Science Facilitation Department, FHI 360, Durham, NC; §§Department of Medicine, Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, NC; and ‖‖Department of Epidemiology, John Hopkins University, Bloomberg School of Public Health, Baltimore, MD.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Safren
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
authors.forename: San-San
authors.initials: SS
authors.lastname: Ou
authors.forename: Marybeth
authors.initials: M
authors.lastname: McCauley
authors.forename: Beatriz
authors.initials: B
authors.lastname: Grinsztejn
authors.forename: Mina C
authors.initials: MC
authors.lastname: Hosseinipour
authors.forename: Nagalingeswaran
authors.initials: N
authors.lastname: Kumarasamy
authors.forename: Theresa
authors.initials: T
authors.lastname: Gamble
authors.forename: Irving
authors.initials: I
authors.lastname: Hoffman
authors.forename: David
authors.initials: D
authors.lastname: Celentano
authors.forename: Ying Qing
authors.initials: YQ
authors.lastname: Chen
authors.forename: Myron S
authors.initials: MS
authors.lastname: Cohen
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D003376:Counseling; D018562:Disease Transmission, Infectious / Q000517:prevention & control*; D005191:Family Characteristics; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008603:Mental Health; D012725:Sexual Behavior; D012747:Sexual Partners; D019562:Viral Load; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents