Lippman Sheri A, Shade Starley B, Sumitani Jeri, DeKadt Julia, Gilvydis Jennifer M, Ratlhagana Mary Jane, Grignon Jessica, Tumbo John, Gilmore Hailey, Agnew Emily, Saberi Parya, Barnhart Scott, Steward Wayne T
Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, UCSF Box 0886, 550 16th Street, 3rd Floor, San Francisco, CA, 94143, USA.
International Training and Education Center for Health South Africa, University of Washington, 232 Bronkhorst Street, Pretoria, Republic of South Africa.
Trials. 2016 Feb 6;17:68. doi: 10.1186/s13063-016-1190-y.
BACKGROUND: In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world's largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messaging or short message service (SMS) and peer-navigation services. METHODS/DESIGN: We designed a cluster randomized trial to assess the efficacy of an SMS intervention and a peer-navigation intervention to improve retention in care and treatment, timely linkage to care and treatment, medication adherence, and prevention behaviors in South Africa. Eighteen primary and community healthcare clinics in Rustenburg and Moses Kotane Sub-districts in the North West Province were randomized to one of three conditions: SMS intervention (n = 7), peer navigation intervention (n = 7), or standard of care (n = 4). Approximately 42 participants are being recruited at each clinic, which will result in a target of 750 participants. Eligible participants include patients accessing HIV testing or care in a study clinic, recently diagnosed with HIV, aged 18 years or older, and with access to a cellular telephone where they are willing to receive automated SMS with HIV-related messaging. Data collection includes extraction of visit information from clinical files and participant surveys at baseline, 6 months, and 12 months. Intent-to-treat (ITT) analysis will explore differences between randomization arms and the primary outcome of patient retention in care at 12 months following enrollment. We will also explore secondary outcomes including participants' a) timely linkage to care (within 3 months of HIV diagnosis), b) adherence to treatment based on self-report and clinic's medication dispensation dates, and c) condom-use behaviors. DISCUSSION: The findings will allow us to compare the efficacy of two complementary interventions, one that requires fewer resources to implement (SMS) and one (peer navigation) that offers more flexibility in terms of the patient barriers to care that it can address. TRIAL REGISTRATION: NCT02417233, registered 12 December 2014.
背景:在南非等艾滋病毒负担沉重的国家,该国的疫情仍是全球最严重的,提高抗逆转录病毒疗法的早期接受率和持续依从性能够在很大程度上预防艾滋病毒感染。然而,患者接受治疗和持续接受治疗的比例未达到遏制疫情所需的水平。在撒哈拉以南非洲地区,有两种策略已显示出在艾滋病毒治疗过程中减少患者流失的潜力,即使用短信或短消息服务(SMS)以及同伴导航服务。 方法/设计:我们设计了一项整群随机试验,以评估短信干预和同伴导航干预对提高南非患者治疗依从性、及时接受治疗、药物依从性以及预防行为的效果。西北省勒斯滕堡和摩西·科塔内分区的18家初级和社区医疗诊所被随机分为三种情况之一:短信干预组(n = 7)、同伴导航干预组(n = 7)或标准治疗组(n = 4)。每家诊所大约招募42名参与者,目标是招募750名参与者。符合条件的参与者包括在研究诊所接受艾滋病毒检测或治疗的患者,他们最近被诊断出感染艾滋病毒,年龄在18岁及以上,并且有手机且愿意接收与艾滋病毒相关的自动短信。数据收集包括在基线、6个月和12个月时从临床档案和参与者调查中提取就诊信息。意向性分析(ITT)将探讨随机分组组之间的差异以及入组后12个月时患者持续接受治疗的主要结局。我们还将探讨次要结局,包括参与者:a)及时接受治疗(在艾滋病毒诊断后3个月内),b)根据自我报告和诊所药物配给日期的治疗依从性,以及c)使用避孕套的行为。 讨论:研究结果将使我们能够比较两种互补干预措施的效果,一种实施所需资源较少(短信干预),另一种(同伴导航)在解决患者接受治疗的障碍方面提供了更大的灵活性。 试验注册:NCT02417233,于2014年12月12日注册。
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