1. Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya
- Author
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Hyunsan Cho, David Okumu, Winnie K. Luseno, Isabella Mbai, Marcia M. Hobbs, Benson W Millimo, Carolyne Atieno, Carolyn Tucker Halpern, Denise Dion Hallfors, and Shane Hartman
- Subjects
medicine.medical_specialty ,Pediatrics ,Adolescent ,Herpesvirus 2, Human ,Sexual Behavior ,Blotting, Western ,Population ,Enzyme-Linked Immunosorbent Assay ,HIV Infections ,Context (language use) ,Dermatology ,Anxiety ,Antibodies, Viral ,Truth Disclosure ,Article ,Acquired immunodeficiency syndrome (AIDS) ,Internal medicine ,Epidemiology ,Humans ,Medicine ,education ,education.field_of_study ,Herpes Genitalis ,business.industry ,medicine.disease ,Kenya ,Clinical trial ,Distress ,Infectious Diseases ,Adolescent Behavior ,Adolescent Health Services ,Child, Orphaned ,business ,Psychosocial ,Algorithms ,Biomarkers ,Follow-Up Studies ,Adolescent health - Abstract
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 manufacturer9s 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.
- Published
- 2015
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