72014
document
Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya . 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 .
72015
Intervention_Educational
western blot
72016
Outcome_Mental
moderate brief stress after disclosure
72017
Outcome_Mental
longer and more severe distress
72018
Outcome_Physical
Self-reported virginity
72019
Outcome_Physical
WB-confirmed positives
72020
Outcome_Physical
false-positive test results
72021
Outcome_Physical
false negatives
72022
Participant_Age
adolescent
72023
Participant_Condition
HIV
72024
Participant_Age
adolescent
72025
Participant_Age
adolescent
72026
Participant_Sample-size
837
72027
Participant_Age
youth
72028
Participant_Sample-size
28
72029
Participant_Age
adolescent participants