HIV Prevention Trials Network (HPTN) 078:
Optimizing Surveillance and Enhancing Treatment for MSM in the United States

Protocol Co-Chairs: 

Robert Remien, PhD

Chris Beyrer MD, MPH

Funding Agency:

National Institute of Allergy and Infectious Diseases (NIAID)

Study Location:

Baltimore, MD

Boston, MA

Birmingham, AB

Atlanta, GA

Description:

HPTN 078 is a US-based research study designed to develop and determine the effectiveness of a combined HIV prevention strategy that includes a method to identify, recruit, and link MSM to HIV care and an intervention to help HIV-infected MSM achieve and maintain viral suppression.

Approximately 2700 MSM over the age of 16 will be recruited in four US cities (Atlanta, Ga.; Baltimore, Md.; Birmingham, Ala.; and Boston, Mass.). These cities were selected because they have prior evidence of high HIV burden among MSM. Of the 2700 MSM recruited, 356 HIV-infected MSM who are not virally suppressed will be enrolled into one of two study arms and followed for 24 months.

HPTN 078 will be the first HPTN study to use a recruitment method known as deep-chain respondent driven sampling (DC-RDS) to identify and recruit HIV-infected MSM. DC-RDS uses a small group of participants, known as “seeds”, who are well connected within the population to recruit other MSM they know into the study. The MSM recruited by the “seeds” repeat the process and refer other MSM they know and so on. This type of recruitment process has previously been shown to be effective in recruiting hard to reach populations. The study team will assess the ability of DC-RDS to identify and recruit HIV-infected MSM in the US who are not virally suppressed.

The enrolled MSM will be randomized to either the standard of care (SOC) or the study intervention arm, which is designed to enhance engagement in HIV care. Participants randomized to the intervention arm will work with a case manager (CM), who will help the participant link to and remain engaged in HIV care, including health services navigation and ART adherence counseling. Participants in the intervention arm will also have the option to receive automated reminders for ART adherence and appointments via text, email and phone. The control arm will the SOC for linkage to care, ART adherence and retention in care. The study team will compare how well the intervention and SOC arms achieve viral suppression 24 months after enrollment.

Presentations/
Publications:

 

  • Mitchell, K., Hoots, B., Dimitrov, D., Farley, J., Gelman, M., German, D., Flynn, C., Adeyeye, A., Remien, R., Beyrer, C., Paz-Bailey, G., Boily, M. “Potential Impact on HIV Incidence of Increasing Viral Suppression among HIV-positive MSM in Baltimore: Mathematical Modeling for HPTN 078” presented at Imperial College London, London, UK October 19, 2016.