Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.

短信服务与同伴导航改善南非HIV照护参与度的效果评价：一项三臂整群随机对照试验方案。

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2016
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Abstract
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.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.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.NCT02417233, registered 12 December 2014.
在人类免疫缺陷病毒（HIV）高负担国家（如南非，其疫情规模仍居全球之首），提高抗逆转录病毒疗法的早期启动率与持续依从性，可带来显著的HIV预防效益。然而，目前患者转介并留存至诊疗体系的比例尚未达到遏制疫情所需的水平。在撒哈拉以南非洲地区，已展现出减少HIV诊疗级联各环节人员流失潜力的两种策略是：使用短信服务（SMS）以及同伴导航（peer-navigation）服务。 我们设计了一项整群随机试验，旨在评估短信干预和同伴导航干预在南非提高诊疗留存率、促进及时转介诊疗、提高用药依从性以及改善预防行为方面的有效性。本研究将西北省勒斯滕堡（Rustenburg）和摩西科塔内（Moses Kotane）分区的18家初级和社区卫生保健诊所随机分配至以下三组之一：短信干预组（n = 7）、同伴导航干预组（n = 7）或常规护理组（n = 4）。每家诊所计划招募约42名受试者，目标总人数为750人。入选标准包括：在研究诊所接受HIV检测或诊疗、新确诊HIV阳性、年龄在18周岁及以上、拥有手机且愿意接收HIV相关自动化短信的患者。数据收集包括从临床档案中提取就诊信息，以及在基线、第6个月和第12个月对受试者进行的问卷调查。我们将采用意向性治疗（ITT）分析，探讨不同随机组之间的差异，主要终点为入组后12个月时的患者诊疗留存率。我们还将探讨次要终点，包括受试者的：a）及时转介治疗（确诊HIV后3个月内），b）基于自报数据和诊所发药日期的治疗依从性，以及 c）安全套使用行为。 研究结果将有助于我们比较这两种互补干预措施的有效性：一种实施成本和资源需求较低（短信服务），另一种在应对患者就诊障碍方面则具有更高的灵活性（同伴导航）。 NCT02417233，注册于2014年12月12日。
Reference Key
lippman2016evaluationtrials Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors 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;
Journal Trials
Year 2016
DOI
10.1186/s13063-016-1190-y
URL
Keywords
Screening childhood obesity feedback parental views routine measurement programmes

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