Social adverse events experienced by trans women and other men who have sex with men (MSM) participating in a HIV pre-exposure prophylaxis (PrEP) trial
Background: The iPrEx study found that oral FTC/TDF HIV PrEP is safe and effective
for prevention of HIV acquisition in MSM. MSM participating in HIV prevention trials may
experience social harms (SH) due to disclosure of trial participation, sexual
orientation, and/or sexual practices.
Methods: Every 12 weeks during study follow-up, study staff inquired, followed-up
and documented the occurrence of SH including the category and severity of
social impact, disclosure of study participation, and action taken by staff and
by the participant until resolution or study exit.
Results: iPrEx enrolled 2,499 participants at 11 sites in 6
countries in Asia, Africa, South and North America. Between July 2007 and
December 2010, 82 participants (3.2%) reported 89 SH, 61.8% from Peru. Half of
the events were reported between enrollment and week 24 of study participation.
Most SH arose from disclosure of study participation to family, partners, friends
and co-workers. In 48.3% of these reports, unintended disclosure was known to someone seeing participant's study medication or materials (informed consent forms and/or laboratory results). Fewer (5.6%) were rated as
severe involving dissolution of a relationship, problems with employment, and
situations with the government agencies due to participation.
Few consequences of social harms ended up in participants withdrawing from the
study (5), moving out of their house (8), and loss of employment (3). Few others
stopped taking the study medication (3). Public reference to study participants
as “high risk” was noted as social harm (3). By the end of the
study, 84.3% of SH resolved after a median of 8 days.
Conclusion:
Few participants reported SH, which mainly arose from disclosure
of study participation that resulted in negative experiences. Linkage of HIV
prevention activities with educational and social programs is critically
important for the success of prevention initiatives and the welfare of
participants.
P. Goicochea1,2, J.R. Lama2, V. McMahan1, B. Postle3, D. Glidden4, F. Wang4, J.V. Guanira2, O. Montoya5, R. Amico6, J.J. McConnell1, R.M. Grant1,7, iPrEx Study Team
1J. David Gladstone Institutes, Gladstone Institute of Virology and Immunology, San Francisco, United States, 2Investigaciones Medicas en Salud, Lince, Peru, 3DF/Net, Seattle, United States, 4University of California - San Francisco, Biostatistics, San Francisco, United States, 5Fundacion Ecuatoriana Equidad, Guayaquil, Ecuador, 6University of Connecticut, Michigan, United States, 7University of California – San Francisco, San Francisco, United States