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

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 indeterminant samples confirmed by Western blot (WB); the psychosocial response to disclosure; and whether reports of sexual behavior and HSV-2 symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya

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

OBJECTIVES: 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 indeterminant samples confirmed by Western blot (WB); the psychosocial response to disclosure; and whether reports of sexual behavior 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; 6 as indeterminate. Of these, 22 positive and all indeterminants 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 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