同伴导航干预维持 HIV 阳性男性和出狱跨性别女性病毒抑制效果:LINK LA 随机临床试验。
Effectiveness of a Peer Navigation Intervention to Sustain Viral Suppression Among HIV-Positive Men and Transgender Women Released From Jail: The LINK LA Randomized Clinical Trial.
机构信息
Department of Medicine, Division of General Internal Medicine and Health Services Research, Geffen School of Medicine, University of California, Los Angeles.
Department of Health Policy and Management, Fielding School of Public Health, University of California, Los Angeles.
出版信息
JAMA Intern Med. 2018 Apr 1;178(4):542-553. doi: 10.1001/jamainternmed.2018.0150.
IMPORTANCE
Diagnosis of human immunodeficiency virus (HIV) infection, linkage and retention in care, and adherence to antiretroviral therapy are steps in the care continuum enabling consistent viral suppression for people living with HIV, extending longevity and preventing further transmission. While incarcerated, people living with HIV receive antiretroviral therapy and achieve viral suppression more consistently than after they are released. No interventions have shown sustained viral suppression after jail release.
OBJECTIVE
To test the effect on viral suppression in released inmates of the manualized LINK LA (Linking Inmates to Care in Los Angeles) peer navigation intervention compared with standard transitional case management controls.
DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted from December 2012 through October 2016 with people living with HIV being released from Los Angeles (LA) County Jail. All participants were (1) 18 years or older; (2) either men or transgender women diagnosed with HIV; (3) English speaking; (4) selected for the transitional case management program prior to enrollment; (5) residing in LA County; and (6) eligible for antiretroviral therapy.
MAIN OUTCOMES AND MEASURES
Change in HIV viral suppression (<75 copies/mL) over a 12-month period.
INTERVENTIONS
During the 12-session, 24-week LINK LA Peer Navigation intervention, trained peer navigators counseled participants on goal setting and problem solving around barriers to HIV care and adherence, starting while the participants were still in jail. After their release, they continued counseling while they accompanied participants to 2 HIV care visits, then facilitated communication with clinicians during visits.
RESULTS
Of 356 participants randomized, 151 (42%) were black; 110 (31%) were Latino; 303 (85%) were men; 53 (15%) were transgender women; and the mean (SD) age was 39.5 (10.4) years. At 12 months, viral suppression was achieved by 62 (49.6%) of 125 participants in the peer navigation (intervention) arm compared with 45 (36.0%) of 125 in the transitional case management (control) arm, for an unadjusted treatment difference of 13.6% (95% CI, 1.34%-25.9%; P = .03). In the repeated measures, random effects, logistic model the adjusted probability of viral suppression declined from 52% at baseline to 30% among controls, while those in the peer navigation arm maintained viral suppression at 49% from baseline to 12 months, for a difference-in-difference of 22% (95% CI, 0.03-0.41; P = .02).
CONCLUSIONS AND RELEVANCE
The LINK LA peer navigation intervention was successful at preventing declines in viral suppression, typically seen after release from incarceration, compared with standard transitional case management. Future research should examine ways to strengthen the intervention to increase viral suppression above baseline levels.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT01406626.
重要性
人类免疫缺陷病毒 (HIV) 感染的诊断、与医疗保健机构的联系和保留、以及抗逆转录病毒治疗的依从性,是使 HIV 感染者持续病毒抑制、延长寿命和防止进一步传播的护理连续体中的步骤。在监禁期间,HIV 感染者接受抗逆转录病毒治疗,并且比释放后更能持续抑制病毒。没有干预措施显示在释放后仍能持续抑制病毒。
目的
通过比较 LINK LA(洛杉矶囚犯联系关怀项目)同伴导航干预与标准过渡性病例管理对照组,检测对释放囚犯中病毒抑制的影响。
设计、地点和参与者:这是一项从 2012 年 12 月至 2016 年 10 月进行的随机临床试验,涉及从洛杉矶(LA)县监狱释放的 HIV 感染者。所有参与者均(1)年龄在 18 岁或以上;(2)被诊断患有 HIV 的男性或跨性别女性;(3)会说英语;(4)在入组前被选入过渡性病例管理项目;(5)居住在洛杉矶县;(6)有资格接受抗逆转录病毒治疗。
主要结局和测量指标
在 12 个月内 HIV 病毒抑制(<75 拷贝/毫升)的变化。
干预措施
在 24 周的 12 次 LINK LA 同伴导航干预中,接受培训的同伴导航员就 HIV 护理和治疗依从性障碍方面的目标设定和解决问题对参与者进行咨询,该咨询从参与者仍在监狱时开始。在他们获释后,他们继续进行咨询,同时陪同参与者进行 2 次 HIV 护理就诊,然后在就诊期间促进与临床医生的沟通。
结果
在 356 名随机分组的参与者中,151 名(42%)为黑人;110 名(31%)为拉丁裔;303 名(85%)为男性;53 名(15%)为跨性别女性;平均(标准差)年龄为 39.5(10.4)岁。在 12 个月时,125 名同伴导航(干预)组中的 62 名(49.6%)参与者实现了病毒抑制,而 125 名过渡性病例管理(对照组)组中的 45 名(36.0%)参与者实现了病毒抑制,未经调整的治疗差异为 13.6%(95%置信区间,1.34%-25.9%;P=0.03)。在重复测量的随机效应逻辑模型中,调整后的病毒抑制概率从基线时的 52%下降到对照组的 30%,而同伴导航组的参与者在基线到 12 个月期间仍保持 49%的病毒抑制,差异为 22%(95%置信区间,0.03-0.41;P=0.02)。
结论和相关性
与标准过渡性病例管理相比,LINK LA 同伴导航干预成功地防止了通常在监禁释放后出现的病毒抑制下降。未来的研究应探讨如何加强干预措施,使病毒抑制率超过基线水平。
试验注册
clinicaltrials.gov 标识符:NCT01406626。
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