Elul Batya, Lamb Matthew R, Lahuerta Maria, Abacassamo Fatima, Ahoua Laurence, Kujawski Stephanie A, Tomo Maria, Jani Ilesh
ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, New York, United States of America.
Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, United States of America.
PLoS Med. 2017 Nov 14;14(11):e1002433. doi: 10.1371/journal.pmed.1002433. eCollection 2017 Nov.
Concerning gaps in the HIV care continuum compromise individual and population health. We evaluated a combination intervention strategy (CIS) targeting prevalent barriers to timely linkage and sustained retention in HIV care in Mozambique.
In this cluster-randomized trial, 10 primary health facilities in the city of Maputo and Inhambane Province were randomly assigned to provide the CIS or the standard of care (SOC). The CIS included point-of-care CD4 testing at the time of diagnosis, accelerated ART initiation, and short message service (SMS) health messages and appointment reminders. A pre-post intervention 2-sample design was nested within the CIS arm to assess the effectiveness of CIS+, an enhanced version of the CIS that additionally included conditional non-cash financial incentives for linkage and retention. The primary outcome was a combined outcome of linkage to care within 1 month and retention at 12 months after diagnosis. From April 22, 2013, to June 30, 2015, we enrolled 2,004 out of 5,327 adults ≥18 years of age diagnosed with HIV in the voluntary counseling and testing clinics of participating health facilities: 744 (37%) in the CIS group, 493 (25%) in the CIS+ group, and 767 (38%) in the SOC group. Fifty-seven percent of the CIS group achieved the primary outcome versus 35% in the SOC group (relative risk [RR]CIS vs SOC = 1.58, 95% CI 1.05-2.39). Eighty-nine percent of the CIS group linked to care on the day of diagnosis versus 16% of the SOC group (RRCIS vs SOC = 9.13, 95% CI 1.65-50.40). There was no significant benefit of adding financial incentives to the CIS in terms of the combined outcome (55% of the CIS+ group achieved the primary outcome, RRCIS+ vs CIS = 0.96, 95% CI 0.81-1.16). Key limitations include the use of existing medical records to assess outcomes, the inability to isolate the effect of each component of the CIS, non-concurrent enrollment of the CIS+ group, and exclusion of many patients newly diagnosed with HIV.
The CIS showed promise for making much needed gains in the HIV care continuum in our study, particularly in the critical first step of timely linkage to care following diagnosis.
ClinicalTrials.gov NCT01930084.
艾滋病病毒(HIV)照护连续过程中的差距影响个人和人群健康。我们评估了一种综合干预策略(CIS),该策略针对莫桑比克HIV照护中及时转介和持续留存的常见障碍。
在这项整群随机试验中,马普托市和伊尼扬巴内省的10家初级卫生机构被随机分配提供CIS或标准照护(SOC)。CIS包括诊断时的即时CD4检测、加速启动抗逆转录病毒治疗(ART)以及短信健康信息和预约提醒。在CIS组内采用干预前后的双样本设计,以评估CIS+的有效性,CIS+是CIS的强化版本,额外包括针对转介和留存的有条件非现金经济激励措施。主要结局是诊断后1个月内与照护机构建立联系并在12个月时留存的综合结局。2013年4月22日至2015年6月30日,我们在参与研究的卫生机构的自愿咨询和检测诊所中,从5327名年龄≥18岁且被诊断为HIV的成年人中纳入了2004名:CIS组744名(37%),CIS+组493名(25%),SOC组767名(38%)。CIS组57%的患者达到主要结局,而SOC组为35%(CIS组与SOC组的相对风险[RR] = 1.58,95%置信区间[CI] 1.05 - 2.39)。CIS组89%的患者在诊断当天就与照护机构建立了联系,而SOC组为16%(CIS组与SOC组的RR = 9.13,95% CI 1.65 - 50.40)。在综合结局方面,给CIS增加经济激励措施没有显著益处(CIS+组55%的患者达到主要结局,CIS+组与CIS组的RR = 0.96,95% CI 0.81 - 1.16)。主要局限性包括使用现有病历评估结局、无法分离CIS各组成部分的效果、CIS+组非同步入组以及排除了许多新诊断为HIV的患者。
在我们的研究中,CIS有望在HIV照护连续过程中取得急需的进展,特别是在诊断后及时与照护机构建立联系这一关键的第一步。
ClinicalTrials.gov NCT01930084