title: Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya.
abstract: OBJECTIVE
  Herpes simplex virus type 2 (HSV-2) biomarkers are often used in adolescent sub-Saharan HIV prevention studies, but evaluations of test performance and disclosure outcomes are rare in the published literature. Therefore, we investigated the proportion of ELISA-positive and indeterminate samples confirmed by western blot (WB), the psychosocial response to disclosure and whether reports of sexual behaviour and HSV-2 symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya.
  
  
  METHODS
  In 2011, 837 Kenyan orphan youth in grades 7 and 8 enrolled in an HIV prevention clinical trial with HSV-2 biomarker outcomes. We used a modified algorithm for the Kalon HSV-2 ELISA to improve specificity; positive and indeterminate results were WB tested. We developed culturally sensitive protocols for disclosing positive results, and documented psychosocial responses, reports of sexual contact and HSV-2 symptoms.
  
  
  RESULTS
  28 adolescents (3.3%) were identified as HSV-2 seropositive, six as indeterminate. Of these, 22 positive and all indeterminates were WB tested; 20 and 5, respectively, were confirmed positive. Most youth reported moderate brief stress after disclosure; 22% reported longer and more severe distress. Boys were more likely to be in the latter category. Self-reported virginity was highly inconsistent with WB-confirmed positives.
  
  
  CONCLUSIONS
  The higher than manufacturer's cut-off for Kalon ELISA modestly reduced the rate of false-positive test results, but also increased false negatives. Investigators should consider the risk:benefit ratio in deciding whether or not to disclose HSV-2 results to adolescent participants under specific field conditions.
  
  
  BACKGROUND
  NCT01501864.
authors.affiliation: The Pacific Institute for Research and Evaluation, Chapel Hill, North Carolina, USA.
authors.forename: Denise Dion
authors.initials: DD
authors.lastname: Hallfors
authors.affiliation: The Pacific Institute for Research and Evaluation, Chapel Hill, North Carolina, USA.
authors.forename: Hyunsan
authors.initials: H
authors.lastname: Cho
authors.affiliation: School of Nursing, Moi University, Eldoret, Kenya.
authors.forename: Isabella I
authors.initials: II
authors.lastname: Mbai
authors.affiliation: School of Nursing, Moi University, Eldoret, Kenya.
authors.forename: Benson W
authors.initials: BW
authors.lastname: Millimo
authors.affiliation: School of Nursing, Moi University, Eldoret, Kenya.
authors.forename: Carolyne
authors.initials: C
authors.lastname: Atieno
authors.affiliation: School of Nursing, Moi University, Eldoret, Kenya.
authors.forename: David
authors.initials: D
authors.lastname: Okumu
authors.affiliation: The Pacific Institute for Research and Evaluation, Chapel Hill, North Carolina, USA.
authors.forename: Winnie K
authors.initials: WK
authors.lastname: Luseno
authors.affiliation: The Pacific Institute for Research and Evaluation, Chapel Hill, North Carolina, USA.
authors.forename: Shane
authors.initials: S
authors.lastname: Hartman
authors.affiliation: Department of Maternal and Child Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: Carolyn T
authors.initials: CT
authors.lastname: Halpern
authors.affiliation: Department of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: Marcia M
authors.initials: MM
authors.lastname: Hobbs
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior / Q000523:psychology; D016497:Adolescent Health Services / Q000458:organization & administration*; D000465:Algorithms; D000914:Antibodies, Viral; D001007:Anxiety / Q000209:etiology; D015415:Biomarkers; D015153:Blotting, Western; D054540:Child, Orphaned / Q000523:psychology / Q000706:statistics & numerical data*; D004797:Enzyme-Linked Immunosorbent Assay; D005500:Follow-Up Studies; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006558:Herpes Genitalis / Q000175:diagnosis* / Q000453:epidemiology / Q000523:psychology*; D018258:Herpesvirus 2, Human / Q000302:isolation & purification*; D006801:Humans; D007630:Kenya / Q000453:epidemiology; D012725:Sexual Behavior; D014342:Truth Disclosure
chemical_list: D000914:Antibodies, Viral; D015415:Biomarkers
keywords: ADOLESCENT; AFRICA; HERPES SIMPLEX (CLINICAL); SEROLOGY