SolidarMed, Partnerships for Health, Lesotho.
Department of Medicine, Clinical Research Unit, Swiss Tropical and Public Health Institute, Socinstrasse 57, 4051, Basel, Switzerland.
BMC Public Health. 2020 Mar 30;20(1):425. doi: 10.1186/s12889-020-08535-6.
Despite tremendous progress in controlling the HIV epidemic in sub-Saharan Africa, HIV-related mortality continues to increase among adolescents and young people living with HIV (AYPLHIV). Globally, sub-Saharan Africa accounts for 85% of the AYPLHIV. Overall outcomes along the HIV care cascade are worse among AYPLHIV as compared to all other age groups due to various challenges in accessing and adhering to antiretroviral therapy (ART). New, innovative multicomponent packages of differentiated service delivery (DSD) models, are required to address the specific needs of AYPLHIV. This study aims to evaluate the feasibility and effectiveness of a multicomponent DSD model (PEBRA model) designed for AYPLHIV and coordinated by a peer-educator.
PEBRA (Peer-Educator Based Refill of ART) is a cluster randomized, open-label, superiority trial conducted at 20 health facilities in three districts of Lesotho, Southern Africa. The clusters (health facilities) are randomly assigned to either the PEBRA model or standard of care in a 1:1 ratio, stratified by district. AYPLHIV aged 15-24 years old in care and on ART at one of the clusters are eligible. In the PEBRA model, a peer-educator coordinates the antiretroviral therapy (ART) services - such as medication pick-up, SMS notifications and support options - according to the preferences of the AYPLHIV. The peer-educator delivers this personalized model using a tablet-based application called PEBRApp. The control clusters continue to offer standard of care: ART services coordinated by the nurse. The primary endpoint is viral suppression at 12 months. Secondary endpoints include self-reported adherence to ART, quality of life, satisfaction with care and engagement in care. The target sample size is 300 AYPLHIV. Statistical analyses are conducted and reported in line with CONSORT guidelines for cluster randomized trials.
The PEBRA trial will provide evidence on the feasibility and effectiveness of an inclusive, holistic and preference-based DSD model for AYPLHIV that is coordinated by a peer-educator. Many countries in SSA have an existing peer-educator program. If proven effective, the PEBRA model and PEBRApp have the potential to be scaled up to similar settings.
Clinicaltrials.gov, NCT03969030. Registered on 31 May 2019. More information: www.pebra.info.
尽管在撒哈拉以南非洲地区控制艾滋病毒流行方面取得了巨大进展，但艾滋病毒相关死亡率在感染艾滋病毒的青少年和青年中继续上升（简称“青少年和青年感染者”）。在全球范围内，撒哈拉以南非洲地区占青少年和青年感染者的 85%。由于在接受和坚持抗逆转录病毒治疗（ART）方面存在各种挑战，青少年和青年感染者在艾滋病毒护理各个环节的总体结果均不如其他所有年龄组。需要新的、创新的多组分差异化服务提供（DSD）模式，以满足青少年和青年感染者的特殊需求。本研究旨在评估一种多组分 DSD 模型（PEBRA 模型）的可行性和有效性，该模型专为青少年和青年感染者设计，由同伴教育者协调。
PEBRA（基于同伴教育者的 ART 药物补充）是一项在南部非洲莱索托三个地区的 20 个卫生机构开展的集群随机、开放性、优效性试验。采用集群（卫生机构）随机分配至 PEBRA 模型或标准护理，分配比例为 1:1，并按地区分层。符合条件的是在其中一个集群中接受护理并正在接受 ART 治疗、年龄在 15-24 岁之间的青少年和青年感染者。在 PEBRA 模型中，同伴教育者根据青少年和青年感染者的偏好协调抗逆转录病毒治疗（ART）服务，例如取药、短信通知和支持选项。同伴教育者使用名为 PEBRApp 的基于平板电脑的应用程序提供这种个性化模型。对照集群继续提供标准护理：由护士协调 ART 服务。主要终点是 12 个月时的病毒抑制情况。次要终点包括自我报告的 ART 依从性、生活质量、护理满意度和护理参与度。目标样本量为 300 名青少年和青年感染者。统计分析按照针对集群随机试验的 CONSORT 指南进行。
PEBRA 试验将提供有关由同伴教育者协调的、针对青少年和青年感染者的包容性、全面性和基于偏好的 DSD 模式的可行性和有效性的证据。撒哈拉以南非洲地区的许多国家都有现有的同伴教育者项目。如果被证明有效，PEBRA 模型和 PEBRApp 有可能在类似环境中推广。
Clinicaltrials.gov，NCT03969030。于 2019 年 5 月 31 日注册。更多信息：www.pebra.info。
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