Adherence Guideline Impact Evaluation - Effectiveness of Fast-track Treatment Initiation Counselling 2015-2018 - South Africa

Abstract
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The dataset contains core data on HIV patients who were eligible for fast-track treatment initiation counselling (FTIC) in the Adherence Guidelines evaluation of the South Africa Department of Health and The World Bank. This evaluation's purpose was to assess the effectiveness of five interventions recommended by the Adherence Guidelines by looking at short-term and final outcome results. This data set includes data from the fast-track treatment initiation counselling intervention. The objective was to determine if fast-track treatment initiation counselling improved treatment initiation one month after eligibility, and viral suppression during patient follow-up. There were 12 intervention clinics and 12 control clinics providing the prevailing standard of care. The patients were enrolled from routine data bases into the evaluation without patient contact. The patient-level data include the enrolment clinic, intervention arm, age group, and whether the patient had a diagnosis of tuberculosis at cohort enrolment. The datafile also provides the short-term and final outcome data for the evaluation of FTIC effectiveness. The datafile supports an academic publication on the evaluation.

Geographic coverage
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Provinces of Gauteng, KwaZulu Natal, Limpopo and North West

Analysis unit
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HIV Patient

Universe
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HIV cases eligible to initiate antiretroviral treatment based on South African clinical guidelines

Kind of data
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Clinical data [cli]

Sampling procedure
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The sample size was 730 patients, slightly higher than the target sample size of 720 to allow for missing data. The RapIT study of rapid ART initiation conducted in Gauteng Province PHC clinics, found that about 60% of ART-eligible patients initiated under standard care within 30 days. Conservatively assuming 60% initiation without the intervention and 75% with the intervention, about 30 subjects in each of the 24 clusters were required to detect a difference of 15%. Sample sizes were determined using PASS software for cluster-randomised designs. Each sample size was determined to measure the short-term outcome and calculations assumed a site-clustered design with the clinic as the cluster and 24 clusters evenly split between intervention and control groups. We assumed power of 80% and an alpha of 0.05. Sample sizes accounted for the cluster-randomised design by assuming a coefficient of variation of 0.1.

Patients eligible for inclusion were aged 18 years or above and patients who were not resident in the facility's catchment area, were recorded as having an intention to transfer care to a different facility within 12 months, or were pregnant and eligible for prevention of mother to child transmission were excluded. The specific inclusion criteria for the Fast-track Treatment Initiation Counseling cohort followed the December 2014 national guidelines for HIV care and ART and July 2016 National Adherence Guidelines for Chronic Disease (HIV, tuberculosis and non-communicable diseases). In order to identify eligible patients to enrol, information recorded on their electronic medical record were consulted. At intervention sites, lists were reviewed against clinic records, registers and other documentation for each intervention to identify eligible patients. At control sites, we reviewed lists against clinic records to confirm eligibility. If the patient file was found and eligibility for a cohort was confirmed then patients were enrolled sequentially until the required sample size was reached for the cohort. Due to delays in electronic data capturing data was not complete. To account for this at some sites, individuals receiving each intervention were identified directly from registers for that intervention.

Clinic files were then reviewed to confirm eligibility and patients were enrolled until the required sample size was achieved. For each patient enrolled, regardless of the method used to identify them, patient files were reviewed and information was extracted using an electronic case report form to confirm patients met all eligibility criteria for the cohort.

Mode of data collection
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Other [oth]

Research instrument
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The Case Report Form was composed of multiple modules, each containing specific data fields. The modules covered identifiers and eligibility (including whether the patient had treatment initiation counselling, how often and of what type, and whether a treatment adherence plan had been developed for the patient), as well as demographics and clinical data.

Cleaning operations
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The HE2RO Johannesburg office study team oversaw the development and management of the database. As needed data was converted to SAS and STATA for cleaning and data analysis. The study team reviewed data files on a monthly basis and returned queries to provincial staff for response. All databases were password protected with access restricted to the members of the study team. A fully de-identified data set will be made available through one or more open access portals when the study is closed.

Response rate
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Two subjects (0.2% of total sample size) do not have outcomes as they were not found in the data base providing viral load results, and the patient files were not able to be located during follow-up data collection.

{'Abstract': '本数据集收录了南非卫生部门与世界银行合作进行的依从性指南评估中，符合快速治疗启动咨询（FTIC）资格的艾滋病患者的核心数据。该评估旨在通过审视短期及最终结果，评估依从性指南推荐的五种干预措施的有效性。数据集包含快速治疗启动咨询干预的数据。研究旨在确定快速治疗启动咨询是否能在资格认定一个月后提高治疗启动率，并在患者随访期间实现病毒载量抑制。共有12个干预诊所和12个对照诊所提供标准护理。患者从常规数据库中纳入评估，无需与患者直接接触。患者级别的数据包括注册诊所、干预组、年龄组以及患者是否在队列注册时被诊断为结核病。数据文件还提供了评估FTIC有效性的短期和最终结果数据。该数据文件支持了一篇关于评估的学术出版物。

地理覆盖范围：

豪登省、夸祖鲁纳塔尔省、林波波省和西北省

分析单位：

艾滋病病毒感染者

总体：

根据南非临床指南有资格启动抗逆转录病毒治疗的艾滋病病例

数据类型：

临床数据 [cli]

抽样程序：

样本量为730名患者，略高于目标样本量720，以允许缺失数据。在豪登省公立诊所进行的RAPIT快速ART启动研究显示，大约60%的ART资格患者在接受标准护理的30天内开始治疗。保守估计，在干预措施前60%的患者开始治疗，而在干预措施下75%的患者开始治疗，每个24个簇群中需要大约30名受试者以检测到15%的差异。样本量使用PASS软件针对簇群随机设计来确定。每个样本量均确定用于测量短期结果，计算假定了一个以诊所为簇群、24个簇群在干预组和对照组之间均匀分配的簇群设计。我们假定80%的统计功效和0.05的显著性水平。样本量考虑到簇群随机设计，假定变异系数为0.1。

符合纳入标准的患者年龄在18岁或以上，且不在设施服务区域内居住、在12个月内记录有转诊到不同设施意愿或怀孕且符合预防母婴传播资格的患者被排除。快速治疗启动咨询队列的特定纳入标准遵循2014年12月的国家HIV关怀和ART指南以及2016年7月的国家慢性病依从性指南（HIV、结核病和非传染性疾病）。为了确定合格的患者进行注册，查阅了他们的电子病历信息。在干预地点，审查了名单与诊所记录、登记册和其他文件，以确定每个干预的合格患者。在对照地点，我们审查了名单与诊所记录以确认资格。如果找到患者文件并确认了队列的资格，则按顺序注册患者，直到达到所需的样本量。由于电子数据捕获的延误，某些地点的数据不完整。为此，直接从该干预措施的登记册中确定了接受每个干预措施的个人。

然后审查诊所文件以确认资格，并注册患者，直到达到所需的样本量。对于每位注册的患者，无论使用何种方法识别他们，都会审查患者文件，并使用电子病例报告表提取信息，以确认患者符合队列的所有资格标准。

数据收集方式：

其他 [oth]

研究工具：

病例报告表由多个模块组成，每个模块包含特定的数据字段。模块涵盖了标识符和资格（包括患者是否接受治疗启动咨询、咨询频率和类型，以及是否为患者制定了治疗依从性计划），以及人口统计学和临床数据。

清洗操作：

HE2RO约翰内斯堡办公室研究团队监督了数据库的开发和管理。所需数据被转换为SAS和STATA进行清洗和分析。研究团队每月审查数据文件，并将查询返回给省级工作人员进行回应。所有数据库均通过密码保护，访问权限仅限于研究团队成员。当研究结束时，将通过一个或多个开放获取门户提供完全去识别化的数据集。

应答率：

有两个受试者（占样本总量的0.2%）没有结果，因为它们未在提供病毒载量结果的数据库中找到，且在随访数据收集期间无法找到患者文件。'}