PT  - JOURNAL ARTICLE
AU  - Denise Dion Hallfors
AU  - Hyunsan Cho
AU  - Isabella I Mbai
AU  - Benson W Millimo
AU  - Carolyne Atieno
AU  - David Okumu
AU  - Winnie K Luseno
AU  - Shane Hartman
AU  - Carolyn T Halpern
AU  - Marcia M Hobbs
TI  - Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya
AID  - 10.1136/sextrans-2015-052025
DP  - 2015 Sep 01
TA  - Sexually Transmitted Infections
PG  - 395--400
VI  - 91
IP  - 6
4099  - http://sti.bmj.com/content/91/6/395.short
4100  - http://sti.bmj.com/content/91/6/395.full
SO  - Sex Transm Infect2015 Sep 01; 91
AB  - 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.