Washington, DC - Gay, bisexual and other men who have sex with men and transgender women with HIV, who are not in care, can be engaged in care when reached and connected with HIV treatment services, according to findings from a clinical trial supported by the National Institutes of Health. Nearly half of the study participants achieved and maintained viral suppression by one year, researchers reported today at the 10th IAS Conference on HIV Science (IAS 2019) in Mexico City.
Effective HIV treatment resulting in sustained viral suppression benefits the health of the person with HIV and also prevents sexual transmission of the virus to others. The clinical trial, called HPTN 078, assessed an HIV prevention strategy involving a peer-to-peer recruitment method to identify, recruit and link to HIV care men and transgender women with unsuppressed HIV in the United States. It also evaluated whether a case management intervention could help them achieve and maintain viral suppression.
Ninety-four percent of eligible volunteers with unsuppressed HIV identified through the recruitment process were enrolled in the study and engaged in HIV care, and 91% of these study participants were retained after 12 months. Researchers observed no differences in one-year viral suppression rates between those who received standard HIV care and those who received the case management intervention.
“To end the HIV epidemic in the United States (link is external), we must close implementation gaps to ensure that all people with HIV are diagnosed and receive the treatment and care they need to achieve and maintain viral suppression,” said Anthony S. Fauci, M.D., director of the NIH National Institute of Allergy and Infectious Diseases (NIAID). “The HPTN 078 findings demonstrate that populations not engaged in care are indeed reachable when a concerted effort is made, underscoring the importance of developing and optimizing strategies to identify people with HIV and connect them to HIV treatment services.”
HPTN 078 screened and enrolled volunteers in four U.S. cities with high HIV burdens — Atlanta; Baltimore; Birmingham, Alabama; and Boston. The study was funded by NIAID and the National Institute of Mental Health (NIMH), both part of NIH, and conducted by the NIH-funded HIV Prevention Trials Network (HPTN).
In the United States, the HIV epidemic is concentrated among gay and bisexual men and transgender people, particularly those who are black or Latinx. Of the 144 men and transgender women with unsuppressed HIV enrolled in the study, 84% were black and 7% were Latinx. Two-thirds were unemployed, and 64% reported an annual income less than $20,000. Most (86%) reported having had previous experience with antiretroviral therapy (ART) to treat HIV.
Study participants assigned randomly to the intervention worked with case managers who helped them navigate health care and supportive services and provided tailored support for ART adherence. These study participants also had the option to receive automated motivational messages and reminders to take their medications and to attend appointments by text, email and phone. Participants determined the intensity of the intervention by choosing the frequency and content of interactions with their case manager and automated messaging. Study participants enrolled in the standard care arm were offered existing programs for supportive services, ART initiation, treatment adherence and retention in care at participating HIV clinics in the four cities.
After 12 months, 48% of all study participants had achieved and maintained viral suppression, with no difference between the standard care and case management intervention arms. Notably, it took time for many of the study participants to achieve viral suppression, and the investigators observed progressive increases in rates of viral suppression — 28% at three months, 36% at six months, 39% at nine months and 48% at 12 months. According to the Centers for Disease Control and Prevention, among all adults and adolescents with HIV in the United States, 53% had achieved viral suppression and 49% were retained in continuous HIV care in 2016. The HPTN 078 findings indicate that a large proportion of the men and transgender women with unsuppressed HIV can be engaged or re-engaged in HIV care.
“HPTN 078 highlights the willingness of people with unsuppressed HIV to engage in treatment when connected with HIV care services,” said Dianne Rausch, Ph.D., director of the NIMH Division of AIDS Research. “The lack of difference in viral suppression between the standard care and case management arms underscores the effectiveness of the current standard of HIV care in the United States, but additional interventions appear necessary to further increase the proportion of people who maintain viral suppression.”
“We are encouraged to see that nearly half of participants whose HIV was unsuppressed at the beginning of the study had achieved and maintained viral suppression after one year. However, additional issues — such as high levels of poverty, social factors like stigma, and individual-level factors including mental health and substance use — must be addressed to achieve higher rates of viral suppression among disenfranchised men who have sex with men and transgender women in the United States,” said Chris Beyrer, M.D., M.P.H., of The Johns Hopkins University. Dr. Beyrer, protocol chair of HPTN 078, presented the findings at IAS 2019. Robert H. Remien, Ph.D., of Columbia University co-chaired the study and was lead author on the conference presentation.
To identify gay, bisexual and other men who have sex with men and transgender women with unsuppressed HIV, HPTN 078 investigators assessed a recruitment strategy in which a small group of individuals recruited their peers. The newly recruited people then referred others, who in turn recruited other people. HPTN investigators also recruited people directly into the study. Overall, the investigators screened 1,305 men and transgender women, among whom they identified 154 with unsuppressed HIV, 144 (94%) of whom enrolled in the study.
A study is being planned to build on the HPTN 078 findings to investigate the best ways to reach men who have sex with men with HIV in the southern states of the U.S., the region of the country which has the greatest burden of HIV. A separate HPTN study focused on preventing HIV acquisition and transmission among transgender women also is in development. Additional NIH-funded research aims to develop and optimize HIV prevention and treatment strategies for men, women and transgender people both in the United States and worldwide.
For additional information about HPTN 078, visit ClinicalTrials.gov using identifier NCT02663219.