Iwuji Collins C, Orne-Gliemann Joanna, Larmarange Joseph, Okesola Nonhlanhla, Tanser Frank, Thiebaut Rodolphe, Rekacewicz Claire, Newell Marie-Louise, Dabis Francois
Africa Centre for Population Health, University of KwaZulu-Natal, Durban, South Africa.
Research Department of Infection and Population Health, University College London, London, United Kingdom.
PLoS Med. 2016 Aug 9;13(8):e1002107. doi: 10.1371/journal.pmed.1002107. eCollection 2016 Aug.
The 2015 WHO recommendation of antiretroviral therapy (ART) for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population. We investigated this approach in a cluster-randomised trial in a high HIV prevalence setting in rural KwaZulu-Natal. We present findings from the first phase of the trial and report on uptake of home-based HIV testing, linkage to care, uptake of ART, and community attitudes about ART.
Between 9 March 2012 and 22 May 2014, five clusters in the intervention arm (immediate ART offered to all HIV-positive adults) and five clusters in the control arm (ART offered according to national guidelines, i.e., CD4 count ≤ 350 cells/μl) contributed to the first phase of the trial. Households were visited every 6 mo. Following informed consent and administration of a study questionnaire, each resident adult (≥16 y) was asked for a finger-prick blood sample, which was used to estimate HIV prevalence, and offered a rapid HIV test using a serial HIV testing algorithm. All HIV-positive adults were referred to the trial clinic in their cluster. Those not linked to care 3 mo after identification were contacted by a linkage-to-care team. Study procedures were not blinded. In all, 12,894 adults were registered as eligible for participation (5,790 in intervention arm; 7,104 in control arm), of whom 9,927 (77.0%) were contacted at least once during household visits. HIV status was ever ascertained for a total of 8,233/9,927 (82.9%), including 2,569 ascertained as HIV-positive (942 tested HIV-positive and 1,627 reported a known HIV-positive status). Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial, 559 (47.5%) visited their cluster trial clinic within 6 mo. In the intervention arm, 89% (194/218) initiated ART within 3 mo of their first clinic visit. In the control arm, 42.3% (83/196) had a CD4 count ≤ 350 cells/μl at first visit, of whom 92.8% initiated ART within 3 mo. Regarding attitudes about ART, 93% (8,802/9,460) of participants agreed with the statement that they would want to start ART as soon as possible if HIV-positive. Estimated baseline HIV prevalence was 30.5% (2,028/6,656) (95% CI 25.0%, 37.0%). HIV prevalence, uptake of home-based HIV testing, linkage to care within 6 mo, and initiation of ART within 3 mo in those with CD4 count ≤ 350 cells/μl did not differ significantly between the intervention and control clusters. Selection bias related to noncontact could not be entirely excluded.
Home-based HIV testing was well received in this rural population, although men were less easily contactable at home; immediate ART was acceptable, with good viral suppression and retention. However, only about half of HIV-positive people accessed care within 6 mo of being identified, with nearly two-thirds accessing care by 12 mo. The observed delay in linkage to care would limit the individual and public health ART benefits of universal testing and treatment in this population.
ClinicalTrials.gov NCT01509508.
2015年世界卫生组织建议对所有HIV诊断后立即开始抗逆转录病毒治疗(ART),部分依据是预期对周围人群HIV发病率的影响。我们在夸祖鲁-纳塔尔省农村地区HIV高流行环境下的一项整群随机试验中研究了这种方法。我们展示了试验第一阶段的结果,并报告了家庭HIV检测的接受情况、与治疗的联系、ART的接受情况以及社区对ART的态度。
在2012年3月9日至2014年5月22日期间,干预组(为所有HIV阳性成年人立即提供ART)的5个整群和对照组(根据国家指南提供ART,即CD4细胞计数≤350个/μl)的5个整群参与了试验的第一阶段。每6个月对家庭进行一次访视。在获得知情同意并发放研究问卷后,询问每位成年居民(≥16岁)采集指尖血样以估计HIV流行率,并使用串联HIV检测算法提供快速HIV检测。所有HIV阳性成年人被转介到其所在整群的试验诊所。对识别后3个月未与治疗建立联系的人,由治疗联系团队进行联系。研究程序未设盲。共有12,894名成年人登记为符合参与条件(干预组5,790名;对照组7,104名),其中9,927名(77.0%)在家庭访视期间至少被联系过一次。共确定了8,233/9,927名(82.9%)的HIV状态,包括2,569名被确定为HIV阳性(942名检测HIV阳性,1,627名报告已知HIV阳性状态)。在试验中1,177名之前未接受治疗且至少随访6个月的HIV阳性个体中,559名(47.5%)在6个月内前往其所在整群的试验诊所就诊。在干预组中,89%(194/218)在首次诊所就诊后3个月内开始接受ART。在对照组中,42.3%(83/196)在首次就诊时CD4细胞计数≤350个/μl,其中92.8%在3个月内开始接受ART。关于对ART的态度,93%(8,802/9,460)的参与者同意如果HIV阳性他们希望尽快开始接受ART的说法。估计基线HIV流行率为30.5%(2,028/6,656)(95%CI 25.0%,37.0%)。干预组和对照组在HIV流行率、家庭HIV检测的接受情况、6个月内与治疗的联系以及CD4细胞计数≤350个/μl者3个月内开始接受ART方面无显著差异。与未联系相关的选择偏倚不能完全排除。
家庭HIV检测在该农村人群中受到欢迎,尽管在家中男性较难联系到;立即开始ART是可接受的,病毒抑制和留存情况良好。然而,只有约一半的HIV阳性者在被识别后6个月内获得治疗,近三分之二在12个月内获得治疗。观察到的与治疗联系的延迟将限制该人群中普遍检测和治疗在个体和公共卫生方面的ART益处。
ClinicalTrials.gov NCT01509508