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Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya
  1. Denise Dion Hallfors1,
  2. Hyunsan Cho1,
  3. Isabella I Mbai2,
  4. Benson W Millimo2,
  5. Carolyne Atieno2,
  6. David Okumu2,
  7. Winnie K Luseno1,
  8. Shane Hartman1,
  9. Carolyn T Halpern3,
  10. Marcia M Hobbs4
  1. 1The Pacific Institute for Research and Evaluation, Chapel Hill, North Carolina, USA
  2. 2School of Nursing, Moi University, Eldoret, Kenya
  3. 3Department of Maternal and Child Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  4. 4Department of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  1. Correspondence to Dr Denise Hallfors, The Pacific Institute for Research and Evaluation, 1516 E. Franklin Street, Suite 200, Chapel Hill, NC 27514, USA; hallfors{at}


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.


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