Labhardt Niklaus Daniel, Motlomelo Masetsibi, Cerutti Bernard, Pfeiffer Karolin, Kamele Mashaete, Hobbins Michael A, Ehmer Jochen
Clinical Research Unit, Medical Services and Diagnostic, Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland.
SolidarMed Lesotho, Seboche Hospital, Butha-Buthe, Lesotho.
PLoS Med. 2014 Dec 16;11(12):e1001768. doi: 10.1371/journal.pmed.1001768. eCollection 2014 Dec.
The success of HIV programs relies on widely accessible HIV testing and counseling (HTC) services at health facilities as well as in the community. Home-based HTC (HB-HTC) is a popular community-based approach to reach persons who do not test at health facilities. Data comparing HB-HTC to other community-based HTC approaches are very limited. This trial compares HB-HTC to mobile clinic HTC (MC-HTC).
The trial was powered to test the hypothesis of higher HTC uptake in HB-HTC campaigns than in MC-HTC campaigns. Twelve clusters were randomly allocated to HB-HTC or MC-HTC. The six clusters in the HB-HTC group received 30 1-d multi-disease campaigns (five villages per cluster) that delivered services by going door-to-door, whereas the six clusters in MC-HTC group received campaigns involving community gatherings in the 30 villages with subsequent service provision in mobile clinics. Time allocation and human resources were standardized and equal in both groups. All individuals accessing the campaigns with unknown HIV status or whose last HIV test was >12 wk ago and was negative were eligible. All outcomes were assessed at the individual level. Statistical analysis used multivariable logistic regression. Odds ratios and p-values were adjusted for gender, age, and cluster effect. Out of 3,197 participants from the 12 clusters, 2,563 (80.2%) were eligible (HB-HTC: 1,171; MC-HTC: 1,392). The results for the primary outcomes were as follows. Overall HTC uptake was higher in the HB-HTC group than in the MC-HTC group (92.5% versus 86.7%; adjusted odds ratio [aOR]: 2.06; 95% CI: 1.18-3.60; p = 0. 011). Among adolescents and adults ≥ 12 y, HTC uptake did not differ significantly between the two groups; however, in children <12 y, HTC uptake was higher in the HB-HTC arm (87.5% versus 58.7%; aOR: 4.91; 95% CI: 2.41-10.0; p<0.001). Out of those who took up HTC, 114 (4.9%) tested HIV-positive, 39 (3.6%) in the HB-HTC arm and 75 (6.2%) in the MC-HTC arm (aOR: 0.64; 95% CI: 0.48-0.86; p = 0.002). Ten (25.6%) and 19 (25.3%) individuals in the HB-HTC and in the MC-HTC arms, respectively, linked to HIV care within 1 mo after testing positive. Findings for secondary outcomes were as follows: HB-HTC reached more first-time testers, particularly among adolescents and young adults, and had a higher proportion of men among participants. However, after adjusting for clustering, the difference in male participation was not significant anymore. Age distribution among participants and immunological and clinical stages among persons newly diagnosed HIV-positive did not differ significantly between the two groups. Major study limitations included the campaigns' restriction to weekdays and a relatively low HIV prevalence among participants, the latter indicating that both arms may have reached an underexposed population.
This study demonstrates that both HB-HTC and MC-HTC can achieve high uptake of HTC. The choice between these two community-based strategies will depend on the objective of the activity: HB-HTC was better in reaching children, individuals who had never tested before, and men, while MC-HTC detected more new HIV infections. The low rate of linkage to care after a positive HIV test warrants future consideration of combining community-based HTC approaches with strategies to improve linkage to care for persons who test HIV-positive.
ClinicalTrials.gov NCT01459120. Please see later in the article for the Editors' Summary.
艾滋病项目的成功依赖于医疗机构以及社区中广泛可及的艾滋病检测与咨询（HTC）服务。居家艾滋病检测与咨询（HB - HTC）是一种流行的社区服务方式，旨在为那些未在医疗机构接受检测的人群提供服务。将HB - HTC与其他社区艾滋病检测与咨询方式进行比较的数据非常有限。本试验将HB - HTC与流动诊所艾滋病检测与咨询（MC - HTC）进行比较。
本试验旨在检验HB - HTC活动中艾滋病检测与咨询的接受率高于MC - HTC活动这一假设。12个群组被随机分配至HB - HTC组或MC - HTC组。HB - HTC组的6个群组开展了30次为期1天的多病种活动（每个群组5个村庄），通过挨家挨户上门的方式提供服务；而MC - HTC组的6个群组在30个村庄开展了社区集会活动，随后在流动诊所提供服务。两组的时间分配和人力资源均实现标准化且相等。所有艾滋病病毒感染状况未知或最后一次艾滋病检测时间超过12周且结果为阴性的参与活动者均符合条件。所有结果均在个体层面进行评估。统计分析采用多变量逻辑回归。对性别、年龄和群组效应进行了比值比和p值的调整。在来自12个群组的3197名参与者中，2563名（80.2%）符合条件（HB - HTC组：1171名；MC - HTC组：1392名）。主要结果如下。总体而言，HB - HTC组的艾滋病检测与咨询接受率高于MC - HTC组（92.5%对86.7%；调整后的比值比[aOR]：2.06；95%置信区间[CI]：1.18 - 3.60；p = 0.011）。在12岁及以上的青少年和成年人中，两组的艾滋病检测与咨询接受率无显著差异；然而，在12岁以下儿童中，HB - HTC组的艾滋病检测与咨询接受率更高（87.5%对58.7%；aOR：4.91；95% CI：2.41 - 10.0；p < 0.001）。在接受艾滋病检测与咨询的人群中，114名（4.9%）检测出艾滋病病毒呈阳性，HB - HTC组为39名（3.6%），MC - HTC组为75名（6.2%）（aOR：0.64；95% CI：0.48 - 0.86；p = 0.002）。HB - HTC组和MC - HTC组分别有10名（25.6%）和19名（25.3%）个体在检测呈阳性后的1个月内与艾滋病护理机构建立了联系。次要结果如下：HB - HTC组接触到更多首次检测者，尤其是在青少年和年轻成年人中，且参与者中男性比例更高。然而，在对群组因素进行调整后，男性参与率的差异不再显著。两组参与者的年龄分布以及新诊断出艾滋病病毒呈阳性者的免疫和临床阶段无显著差异。主要研究局限性包括活动限于工作日开展以及参与者中艾滋病病毒感染率相对较低，后者表明两组可能都接触到了未充分暴露于艾滋病病毒的人群。
本研究表明，HB - HTC和MC - HTC均可实现较高的艾滋病检测与咨询接受率。这两种基于社区的策略之间的选择将取决于活动目标：HB - HTC在接触儿童、从未接受过检测的个体和男性方面表现更佳，而MC - HTC检测出更多新的艾滋病病毒感染病例。艾滋病检测呈阳性后与护理机构建立联系的比例较低，这值得未来考虑将基于社区的艾滋病检测与咨询方法与改善艾滋病病毒检测呈阳性者与护理机构联系的策略相结合。
ClinicalTrials.gov NCT01459120。有关编辑总结，请参阅本文后面部分。
