The HPTN 078 study aims to determine how to find and recruit HIV‑positive and virally unsuppressed men who have sex with men (MSM) and transgender women (TGW). The study also aims to determine the effectiveness of a case-manager intervention using motivational interviewing to encourage antiretroviral therapy (ART) adherence and viral suppression. The study team finished enrolling participants in December 2017 and is following them while the data collected during screening and enrollment are analyzed.
Baseline Data and Preliminary Findings:
- More than 1,300 MSM and TGW were screened at four U.S. sites; 144 study participants were enrolled.
- Most participants who were recruited and screened were African American, aged 25 years or older. Many HPTN 078 study participants face socioeconomic challenges including poverty, unemployment and a high level of education (i.e., high school or more).
- More than half of those screened were found to be living with HIV. Ninety-four percent of those who were not virally suppressed were enrolled into the study. Those virally suppressed on ART were not eligible for HPTN 078.
- The high rate of viral suppression among those screened may be related to the fact the study is being conducted at HIV Centers of Excellence where people have access to comprehensive HIV care and support services.
- An alarmingly high proportion of those screened had evidence of active syphilis, with particularly high rates of syphilis coinfection among people living with HIV.
- The case-manager intervention is ongoing. All study participants – both those receiving the intervention and those receiving the standard of care – are being followed for one year. The last follow-up visit is anticipated by March 2019.
- The study team plans on presenting initial results from the screening cohort at HIVR4P in October 2018.