Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya

Sex Transm Infect. 2015 Sep;91(6):395-400. doi: 10.1136/sextrans-2015-052025. Epub 2015 Jul 2.


Objectives: 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.

Trial registration number: NCT01501864.


Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adolescent Behavior / psychology
  • Adolescent Health Services / organization & administration*
  • Algorithms
  • Antibodies, Viral
  • Anxiety / etiology
  • Biomarkers
  • Blotting, Western
  • Child, Orphaned / psychology
  • Child, Orphaned / statistics & numerical data*
  • Enzyme-Linked Immunosorbent Assay
  • Follow-Up Studies
  • HIV Infections / epidemiology
  • HIV Infections / prevention & control*
  • Herpes Genitalis / diagnosis*
  • Herpes Genitalis / epidemiology
  • Herpes Genitalis / psychology*
  • Herpesvirus 2, Human / isolation & purification*
  • Humans
  • Kenya / epidemiology
  • Sexual Behavior
  • Truth Disclosure*


  • Antibodies, Viral
  • Biomarkers

Associated data

  • ClinicalTrials.gov/NCT01501864