Schnall Rebecca, Jia Haomiao, Brin Maeve, Kay Emma S, Wood Olivia R, Abua Joseph, Batey D Scott
School of Nursing, Columbia University, 560 W. 168th street, New York, NY, 10032, USA.
Heilbrunn Department of Population and Family Health, Mailman School of Public Health, Columbia University, New York, NY, 10032, USA.
AIDS Behav. 2025 Jul 10. doi: 10.1007/s10461-025-04811-x.
Given the fragmented condition of the United States healthcare system and the challenges inherent in the lives of poor, stigmatized, and minoritized groups, our study team conducted a multi-site randomized (1:1) controlled efficacy trial of Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS), a combination intervention comprised of both the WiseApp and community health worker delivered health information, among adults with HIV in New York City and Birmingham, Alabama. Data analysis used an intention-to-treat approach. Enrollment for this study was from May 2021-May 2023 with follow-up completed at 6- and 12-months following study enrollment. In the analytic sample of 300 study participants, the mean age was 48.1 years; 219 (73.2%) participants identified as Non-Hispanic Black, 28 (9.4%) as Non-Hispanic White, 39 (13.0%) as Hispanic, and 10 (3.3%) as Other Non-Hispanic. From baseline to six months, the proportion of participants who were virally suppressed increased for both study arms, with OR = 1.16 (SE = 0.26, p = 0.52, 95%CI 0.75-1.79) for standard of care and OR = 1.66 (SE = 0.33, p = 0.010, 95%CI 1.13-2.44) for CHAMPS. However, there was no statistically significant difference in changes between the two study arms (p = 0.28). The CHAMPS intervention did not have a significant effect on HIV viral suppression relative to non-suppression at 12-months compared with the standard of care arm. Nonetheless, these findings should be interpreted in the context of the COVID-19 and Monkeypox pandemic with persistent concerns related to exposure to the viruses and limited access to healthcare and other social services. Trial Registration: ClinicalTrials.gov Identifier: NCT04562649.
鉴于美国医疗保健系统的碎片化状况以及贫困、受污名化和少数群体生活中固有的挑战，我们的研究团队在纽约市和阿拉巴马州伯明翰市的艾滋病毒感染者中开展了一项多地点随机（1:1）对照疗效试验，即社区卫生工作者与移动健康促进病毒抑制（CHAMPS）试验，这是一种由WiseApp和社区卫生工作者提供健康信息组成的联合干预措施。数据分析采用意向性分析方法。本研究的招募时间为2021年5月至2023年5月，随访在研究招募后的6个月和12个月完成。在300名研究参与者的分析样本中，平均年龄为48.1岁；219名（73.2%）参与者为非西班牙裔黑人，28名（9.4%）为非西班牙裔白人，39名（13.0%）为西班牙裔，10名（3.3%）为其他非西班牙裔。从基线到六个月，两个研究组中病毒得到抑制的参与者比例均有所增加，标准治疗组的比值比（OR）=1.16（标准误=0.26，p=0.52，95%置信区间0.75-1.79），CHAMPS组的OR=1.66（标准误=0.33，p=0.010，95%置信区间1.13-2.44）。然而，两个研究组之间的变化没有统计学上的显著差异（p=0.28）。与标准治疗组相比，CHAMPS干预在12个月时对艾滋病毒病毒抑制相对于未抑制没有显著影响。尽管如此，这些发现应在新冠疫情和猴痘疫情的背景下解读，人们持续担心接触这些病毒，且获得医疗保健和其他社会服务的机会有限。试验注册：ClinicalTrials.gov标识符：NCT04562649。
