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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

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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.


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.

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]).

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.

Keywords: HIV-positive; case management; men who have sex with men; randomized controlled trial; viral suppression

Document Type: Research Article

Affiliations: 1: HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NewYork State Psychiatric Institute, Department of Psychiatry, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York 2: The Institute for Sexual and Gender Minority Health and Wellbeing at Northwestern Feinberg School of Medicine, Chicago, Illinois 3: Center for Infectious Disease and Nursing Innovation, Johns Hopkins University School of Nursing, Center for AIDS Research, Johns Hopkins University School of Medicine, Baltimore, Maryland 4: University of Washington, Department of Biostatistics, Fred Hutchinson Cancer Center, Vaccine and Infectious Diseases Division, Seattle, Washington 5: HPTN Leadership and Operations Center, FHI 360, Durham, North Carolina 6: Fred Hutchinson Cancer Center, Seattle, Washington 7: Tulane University School of Social Work, New Orleans, Louisiana 8: The Fenway Institute, Fenway Health and Department of Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts 9: Emory University School of Medicine and Grady Health System, Atlanta, Georgia 10: Department of Behavioral Science and Social Medicine, Florida State University College of Medicine Tallahassee, Florida 11: Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland 12: MRC Centre for Global Infectious Disease Analysis, School of Public Health, HIV Prevention Trials Network Modelling Centre, Imperial College London, London, UK 13: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland 14: Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC 15: Department of Psychiatry, Columbia University Irving Medical Center, New York, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University, Department of Sociomedical Sciences, Columbia University Mailman School of Public Health, New York, New York 16: University of Washington, Seattle, Washington 17: Director, Duke Global Health Institute, Duke University, Durham, North Carolina, USA.

Publication date: February 1, 2023

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