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.
Journal
AIDS (London, England)
ISSN: 1473-5571
Titre abrégé: AIDS
Pays: England
ID NLM: 8710219
Informations de publication
Date de publication:
01 02 2023
01 02 2023
Historique:
pmc-release:
01
02
2024
entrez:
21
12
2022
pubmed:
22
12
2022
medline:
23
12
2022
Statut:
ppublish
Résumé
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. 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.
Identifiants
pubmed: 36541636
doi: 10.1097/QAD.0000000000003411
pii: 00002030-202302010-00002
pmc: PMC9983736
mid: NIHMS1843742
doi:
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
217-231Subventions
Organisme : NIMH NIH HHS
ID : P30 MH043520
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069412
Pays : United States
Organisme : NIMH NIH HHS
ID : T32 MH019139
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068619
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068613
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068617
Pays : United States
Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
Références
Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2014–2018; 2020. Available at: https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-25-1.pdf .
Centers for Disease Control and Prevention. HIV among gay and bisexual men; 2017. Available at: https://www.cdc.gov/hiv/group/msm/index.html .
HIV.gov. People living with HIV; 2019. Available at: https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
Koblin BA, Mayer KH, Eshleman SH, Wang L, Mannheimer S, Del Rio C, et al. Correlates of HIV acquisition in a cohort of Black men who have sex with men in the United States: HIV prevention trials network (HPTN) 061 . PLoS One 2013; 8:e70413.
Centers for Disease Control and Prevention. HIV in the Southern United States; 2019. Available at: https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-in-the-south-issue-brief.pdf .
Millett GA, Peterson JL, Flores SA, Hart TA, Jeffries WL, Wilson PA, et al. Comparisons of disparities and risks of HIV infection in Black and other men who have sex with men in Canada, UK, and USA: a meta-analysis . Lancet 2012; 380:341–348.
Jeffries WL. Trends in diagnosis of HIV infection, linkage to medical care, and viral suppression among men who have sex with men, by race/ethnicity and age—33 Jurisdictions, United States, 2014–2018 . MMWR Morb Mortal Wkly Rep 2020; 38:69.
Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection . Clin Infect Dis 2011; 52:793–800.
Centers for Disease Control and Prevention. HIV in the United States and dependent areas; 2020. Available at: https://www.cdc.gov/hiv/pdf/statistics/overview/cdc-hiv-us-ataglance.pdf .
Silhol R, Boily M-C, Dimitrov D, German D, Flynn C, Farley JE, et al. Understanding the HIV epidemic among MSM in Baltimore: a modeling study estimating the impact of past HIV interventions and who acquired and contributed to infections . J Acquir Immune Defic Syndr 2020; 84:253–262.
Mitchell KM, Hoots B, Dimitrov D, German D, Flynn C, Farley JE, et al. Improvements in the HIV care continuum needed to meaningfully reduce HIV incidence among men who have sex with men in Baltimore, US: a modelling study for HPTN 078 . J Int AIDS Soc 2019; 22:e25246.
Irvine MK, Robertson MM, Nash D, Kulkarni SG, Braunstein SL, Levin B. HIV Care Coordination promotes care re-engagement and viral suppression among people who have been out of HIV medical care: an observational effectiveness study using a surveillance-based contemporaneous comparison group . AIDS Res Ther 2021; 18:1–7.
Xie N, Hu X, Yan H, Ruan L, Liu C, Hu R, et al. Effects of case management on risky sexual behaviors and syphilis among HIV-infected men who have sex with men in china: a randomized controlled study . Sex Transm Dis 2022; 49:22–28.
Metsch LR, Feaster DJ, Gooden L, Matheson T, Stitzer M, Das M, et al. Effect of patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use: a randomized clinical trial . JAMA 2016; 316:156–170.
Sheehan DM, Dawit R, Gbadamosi SO, Fennie KP, Li T, Gebrezgi M, et al. Sustained HIV viral suppression among men who have sex with men in the Miami-Dade County Ryan White Program: the effect of demographic, psychosocial, provider and neighborhood factors . BMC Public Health 2020; 20:1–12.
Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV epidemic: a plan for the United States . JAMA 2019; 321:844–845.
Beyrer C, Malone J, Baral S, Wang Z, Rio CD, Mayer KH, et al. Comparing recruitment strategies to engage hard-to-reach men who have sex with men living with HIV with unsuppressed viral loads in four US cities: results from HPTN 078 . J Int AIDS Soc 2021; 24:e25798.
Abuse S. The Substance Abuse and Mental Illness Symptoms Screener (SAMISS)-Key .
Simoni JM, Pearson CR, Pantalone DW, Marks G, Crepaz N. Efficacy of interventions in improving highly active antiretroviral therapy adherence and HIV-1 RNA viral load: a meta-analytic review of randomized controlled trials . J Acquir Immune Defic Syndr 2006; 1999 (43):S23.
DiIorio C, Resnicow K, McDonnell M, Soet J, McCarty F, Yeager K. Using motivational interviewing to promote adherence to antiretroviral medications: a pilot study . J Assoc Nurses AIDS Care 2003; 14:52–62.
Safren SA, Otto MW, Worth JL, Salomon E, Johnson W, Mayer K, et al. Two strategies to increase adherence to HIV antiretroviral medication: life-steps and medication monitoring . Behav Res Ther 2001; 39:1151–1162.
Samet JH, Horton NJ, Meli S, Dukes K, Tripps T, Sullivan L, et al. A randomized controlled trial to enhance antiretroviral therapy adherence in patients with a history of alcohol problems . Antivir Ther 2005; 10:83–93.
Pradier C, Bentz L, Spire B, Tourette-Turgis C, Morin M, Souville M, et al. Efficacy of an educational and counseling intervention on adherence to highly active antiretroviral therapy: French prospective controlled study . HIV Clin Trials 2003; 4:121–131.
Huang D, Sangthong R, McNeil E, Chongsuvivatwong V, Zheng W, Yang X. Effects of a phone call intervention to promote adherence to antiretroviral therapy and quality of life of HIV/AIDS patients in Baoshan, China: a randomized controlled trial . AIDS Res Treat 2013; 2013:580974.
Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial . Lancet 2010; 376:1838–1845.
Sidney K, Antony J, Rodrigues R, Arumugam K, Krishnamurthy S, D'souza G, et al. Supporting patient adherence to antiretrovirals using mobile phone reminders: patient responses from South India . AIDS Care 2012; 24:612–617.
Lewis MA, Uhrig JD, Bann CM, Harris JL, Furberg RD, Coomes C, et al. Tailored text messaging intervention for HIV adherence: a proof-of-concept study . Health Psychol 2013; 32:248.
Irvin R, Gamble T, Malone J, Wang Z, Wilson E, Hughes J, et al . HPTN 078: high prevalence of HCV antibodies among men who have sex with men (MSM) independent of HIV status. Clin Infect Dis 2020.
Gamble T, Wang Z, Gaydos CA, Batey DS, Mayer K, del Rio C, et al. Finding MSM who may be potential amplified HIV transmitters: results from HPTN 078 . AIDS Res Human Retrovir 2018; 34:178-178.
Fogel JM, Sivay MV, Cummings V, Wilson EA, Hart S, Gamble T, et al. HIV drug resistance in a cohort of HIV-infected MSM in the United States . AIDS 2020; 34:91–101.
Palumbo PJ, Zhang Y, Clarke W, Breaud A, Sivay M, Cummings V, et al. Uptake of antiretroviral treatment and viral suppression among men who have sex with men and transgender women in sub-Saharan Africa in an observational cohort study: HPTN 075 . Int J Infect Dis 1921; 104:465–470.
Colasanti J, Sumitani J, Mehta CC, Zhang Y, Nguyen ML, Del Rio C, et al. Implementation of a rapid entry program decreases time to viral suppression among vulnerable persons living with HIV in the Southern United States . 2018; USA: Oxford University Press, ofy104.
Brennan-Ing M, Seidel L, Rodgers L, Ernst J, Wirth D, Tietz D, et al. The impact of comprehensive case management on HIV client outcomes . PLoS One 2016; 11:e0148865.
Kushel M, Colfax G, Ragland K, Heineman A, Palacio H, Bangsberg DR. Case management is associated with improved antiretroviral adherence and CD4+ cell counts in homeless and marginally housed individuals with HIV infection . Clin Infect Dis 2006; 43:234–242.
Tolley EE, Hamilton EL, Eley N, Maragh-Bass AC, Okumu E, Balán IC, et al. The role of case management in HIV treatment adherence: HPTN 078 . AIDS Behav 2022; 1–12.