1) What are some examples of trial-related harms that participants have experienced, or might experience, at your site or the site you are affiliated with (e.g. loss of housing, social stigma, vaccine induced seropositivity)?
The trial related harms can be classified into the following categories:
Product Related Harm: An example of product related harm include Vaccine Induced Seropositivity (VISP) a serious concern to people participating in HIV vaccine trials. People have reported discrimination and stigma associated with VISP. Another challenge is that VISP it is an unknown concept in our communities. The community understanding of HIV results is that you are either HIV Positive or Negative. We need more education around VISP
Community Related Harm: People participating in HIV prevention trials are perceived as promiscuous and having multiple sexual partners. Some are perceived to be HIV positive despite their participation in HIV prevention trial.
Family related Harm: Some participants have reported physical abuse by either family members or partners due to their lack of disclosure regarding their participation in an HIV prevention trial.
How has your team dealt with these situations? Which stakeholders provided input, and how did they help
Our site has introduced the participant’s support groups to help participants with issues that will disturb their participation in the HIV prevention trials. Groups consisting of cohort groups of participants was introduced during the implementation of FACTS 001 trial. These FACTS clubs also included a sub-group consisting of partners and family members. This intervention has been very useful since it provided a different perspective to stakeholder engagement.
