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HTPN 078: an enhanced case management study to achieve viral suppression among viremic HIV-positive men who have sex with men in the United States; can we reach ETE & 90/90/90 ?
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Remien, Robert H.a,b; Dacus, Jagadīśa-devaśrīc; Farley, Jason E.d,e; Hughes, James P.f; Gamble, Theresag; Wang, Zhe (Zoe)h; Batey, D. Scotti; Mayer, Kenneth H.j; del Rio, Carlosk; Balán, Iván C.l; Irvin, Risham; Mitchell, Kate M.n,o; Cummings, Vanessap; Eshleman, Susan H.p; Conserve, Donaldson F.q; Knox, Justinr,s,t; Yu, Kaiyueu; Beyrer, Chrisv
2023
Reaching targets of at least 90% sustained viral suppression among PWH will likely require an integrated strategies approach that addresses barriers to optimal care and treatment at multiple levels. Further research is needed to achieve this goal, to help end the HIV epidemic among disenfranchised populations in the US and across the globe.....Among the 128 participants at the last study visit, 68 were virally suppressed, with no statistically significant difference between the CM and SOC arms (viral suppression 42% and 53%
To address health disparities and to improve outcomes for all MSM, it is critical to reach higher proportions of MSM with HIV who are not virally suppressed, enhance their linkage to care, and increase their ability to achieve and maintain HIV suppression. These goals are central to the current “Ending the HIV Epidemic: A Plan for The United States” (EHE) [16].
The HPTN 078 study attempted to address two critical steps in the continuum of care for MSM: enhance outreach and recruitment of MSM with HIV infection, but not virally suppressed, through respondent driven sampling (RDS) and direct recruitment [17], and enhance treatment and care via case management to increase the proportion of MSM who achieved sustained viral suppression. This report is focused on the outcome of the second aim of the HPTN 078 study.
The primary goal of HPTN 078 was to find MSM with HIV who were not virally suppressed and to randomize them into one of two arms receiving either the standard of care (SOC, see below) or an enhanced case management (CM) intervention designed to improve viral suppression rates.
•The CM intervention provided a wide range of support services including, health education, clinical care coordination, medication adherence support, and social service assistance. The month-12 assessment included questions about healthcare utilization, stigma, substance use, and mental health.
•Among the 128 participants at the last study visit, 68 were virally suppressed, with no statistically significant difference between the CM and SOC arms (viral suppression 42% and 53%, respectively; adjusted odds ratio = 0.62 [P = 0.15; 95% confidence interval: 0.32, 1.2]).
Most study participants reported a prior HIV diagnosis and were, therefore, aware of their status prior to study participation. Likely reasons for viremia among PWH include not being on ART, poor ART adherence, or treatment failure due to inadequate ART regimen and/or drug resistance. HIV drug resistance was detected in 44 (31%) of 143 individuals at study baseline [30]. Given the recruitment challenges of this often neglected population [17], it is noteworthy that the study team was able to engage these men and retain the majority (90%) of participants in the study for 12 months and that nearly half achieved viral suppression over the course of one year.
Abstract
Objective(s):
After identifying and recruiting men who have sex with men living with HIV and virally unsuppressed, this study attempted to enhance treatment and care via case management to increase the proportion who achieved viral suppression.
Design:
Participants were randomized into one of two study arms: standard of care (SOC) or enhanced case management (CM) intervention. Participants were followed for 12 months with quarterly study assessments, with blood collected for CD4+ cell count testing, HIV viral load testing (primary prespecified outcome), and plasma storage.
Methods:
Participants identified via respondent-driven sampling and direct recruitment and were invited to participate in the randomized controlled trial. The CM intervention provided a wide range of support services including, health education, clinical care coordination, medication adherence support, and social service assistance. The month-12 assessment included questions about healthcare utilization, stigma, substance use, and mental health.
Results:
Among the 144 participants virally unsuppressed at baseline, most had had a previous positive HIV test result; were Black, non-Hispanic, gay and bisexual men, aged 22-50. Among the 128 participants at the last study visit, 68 were virally suppressed, with no statistically significant difference between the CM and SOC arms (viral suppression 42% and 53%, respectively; adjusted odds ratio = 0.62 [P = 0.15; 95% confidence interval: 0.32, 1.2]).
Conclusions:
Reaching targets of at least 90% sustained viral suppression among all people with HIV will likely require more than an individual-level CM approach that addresses barriers to optimal care and treatment at multiple levels.
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