TY - JOUR
T1 - HPTN 078: an enhanced case management study to achieve viral suppression among viremic HIV-positive men who have sex with men in the United States
AU - Remien, Robert H.
AU - Dacus, Jagadīśa Devaśrī
AU - Farley, Jason E.
AU - Hughes, James P.
AU - Gamble, Theresa
AU - Wang, Zhe Zoe
AU - Batey, D. Scott
AU - Mayer, Kenneth H.
AU - Del Rio, Carlos
AU - Balán, Iván C.
AU - Irvin, Risha
AU - Mitchell, Kate M.
AU - Cummings, Vanessa
AU - Eshleman, Susan H.
AU - Conserve, Donaldson F.
AU - Knox, Justin
AU - Yu, Kaiyue
AU - Beyrer, Chris
N1 - Funding Information:
The HIV Prevention Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068619 [HPTN Leadership and Operations Center, PI: Myron Cohen, PhD]), UM1AI068613 [HPTN Statistical and Data Management Center, PI: Deborah Donnell, PhD], UM1AI1068613 [HPTN Laboratory Center, PI: Susan Eshleman, PhD]), with co-funding from the National Institute of Mental Health and the National Institute on Drug Abuse, all components of theU.S. National Institutes of Health. This research was supported by the National Institute ofMentalHealth to the HIVCenter for Clinical and Behavioral Studies atNYState Psychiatric Institute and Columbia University (P30-MH43520; PI: Robert Remien, PhD; T32 MH019139, PI: Theodorus Sandfort, PhD).
PY - 2023/2/1
Y1 - 2023/2/1
N2 - 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.
AB - 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.
KW - case management
KW - HIV-positive
KW - men who have sex with men
KW - randomized controlled trial
KW - viral suppression
U2 - 10.1097/QAD.0000000000003411
DO - 10.1097/QAD.0000000000003411
M3 - Article
C2 - 36541636
AN - SCOPUS:85144292528
SN - 0269-9370
VL - 37
SP - 217
EP - 231
JO - AIDS
JF - AIDS
IS - 2
ER -