Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex with Men (MSM) in the United States
What is HPTN 078?
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 (low level of HIV in the body).
Who is participating in the study?
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.
Why is HPTN 078 important?
According to the U.S. Centers for Disease Control and Prevention, MSM continue to be the group most heavily affected by HIV in the US. While MSM represent approximately two percent of the US population, they accounted for nearly 67% of newly diagnosed HIV infections in the US in 2014. There is an urgent need to develop innovative methods to identify MSM who are HIV-infected and not virally suppressed, as well as ways to help MSM remain in care and achieve viral suppression. Achieving viral suppression is critical both for individual health and to stop HIV transmission within this community.
What will happen during the study?
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.
HPTN 078 Version 2.0
HPTN 078 Version 1.0
- HPTN 078 Protocol V1.0 - 8 Oct 2015
- LoA #5 - 19 April 2017
- LoA #4 - 20 December 2016
- LoA #3 - 23 June 2016
- LoA #2 - 5 May 2016
- LoA #1 - 15 Jan 2016