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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Musa Otieno Ng'ayo; David Friedrich; King K Holmes; Elizabeth Bukusi; Rhoda Ashley Morrow Journal: J Virol Methods Date: 2009-10-23 Impact factor: 2.014
Authors: Hayley Mark; Joy P Nanda; Alain Joffe; Jessica Roberts; Anne Rompalo; Johan Melendez; Jonathan Zenilman Journal: J Am Coll Health Date: 2008 Nov-Dec
Authors: Aaron A R Tobian; Blake Charvat; Victor Ssempijja; Godfrey Kigozi; David Serwadda; Frederick Makumbi; Boaz Iga; Oliver Laeyendecker; Melissa Riedesel; Amy Oliver; Michael Z Chen; Steven J Reynolds; Maria J Wawer; Ronald H Gray; Thomas C Quinn Journal: J Infect Dis Date: 2009-04-01 Impact factor: 5.226
Authors: Rashida A Ferrand; Lucia Munaiwa; John Matsekete; Tsitsi Bandason; Kusum Nathoo; Chiratidzo E Ndhlovu; Shungu Munyati; Frances M Cowan; Diana M Gibb; Elizabeth L Corbett Journal: Clin Infect Dis Date: 2010-10-01 Impact factor: 9.079
Authors: Esther E Freeman; Helen A Weiss; Judith R Glynn; Pamela L Cross; James A Whitworth; Richard J Hayes Journal: AIDS Date: 2006-01-02 Impact factor: 4.177
Authors: Marshall W Munjoma; Edith N Kurewa; Munyaradzi P Mapingure; Grace V Mashavave; Mike Z Chirenje; Simbarashe Rusakaniko; Akhtar Hussain; Babill Stray-Pedersen Journal: BMC Womens Health Date: 2010-01-12 Impact factor: 2.809
Authors: Pauli N Amornkul; Hilde Vandenhoudt; Peter Nasokho; Frank Odhiambo; Dufton Mwaengo; Allen Hightower; Anne Buvé; Ambrose Misore; John Vulule; Charles Vitek; Judith Glynn; Alan Greenberg; Laurence Slutsker; Kevin M De Cock Journal: PLoS One Date: 2009-07-31 Impact factor: 3.240
Authors: Marcia M Hobbs; Sophie W Mwanyumba; Winnie K Luseno; Shane Hartman; Carolyn T Halpern; Denise D Hallfors; Hyunsan Cho Journal: Sex Transm Dis Date: 2017-02 Impact factor: 2.830
Authors: Charlotte James; Manale Harfouche; Nicky J Welton; Katherine Me Turner; Laith J Abu-Raddad; Sami L Gottlieb; Katharine J Looker Journal: Bull World Health Organ Date: 2020-03-25 Impact factor: 9.408