Social harms and benefits reported by HIV Vaccine Trial Network(HVTN) participants across different countries.

Abstract

HIV vaccine trials bring to the limelight socio-behavioral issues that extend beyond the borders of traditional vaccine trials but, there is a dearth of knowledge on these issues. This study employed a cross-protocol approach, using data from 51 closed protocols across HIV Vaccine Trial Network (HVTN) sites in thirteen countries. A total of 937 social harms were reported by 789 (7.5%) of 10,483 participants. The most common reported event was problems with personal relationship (n=704, 75.1%). Issues with insurance, education, housing, travel/immigration, and military/government agencies were minimal (<10 events). Most events (n=656, 70%) were considered resolved by the end of study. Logistic regression analysis showed that sex and age were not significantly associated with reporting a social harm, whereas region, participants’ study phase, and treatment group were significant predictors. A total of 6,562 participants reported at least one benefit at first assessment and the most common benefit reported was helping others/altruism(n=3,100). Age and treatment group were not associated with reporting at least one benefit. However, there were significant differences by regions, sex and study phase. Our study showed that the reporting of social harms was low across HVTN sites while a high number of participants reported benefit.