肯尼亚的 HIV 研究与产前保健整合在妊娠中的应用：一项集群随机对照试验的设计、方法和基线结果。

The study of HIV and antenatal care integration in pregnancy in Kenya: design, methods, and baseline results of a cluster-randomized controlled trial.

机构信息

Department of Health Care Organization and Policy, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.

出版信息

PLoS One. 2012;7(9):e44181. doi: 10.1371/journal.pone.0044181. Epub 2012 Sep 6.

BACKGROUND

Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma.

METHODOLOGY/PRINCIPAL FINDINGS: A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines.

CONCLUSIONS/SIGNIFICANCE: This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving to eliminate vertical transmission of HIV and improve maternal health.

TRIAL REGISTRATION

ClinicalTrials.gov NCT00931216 http://clinicaltrials.gov/ct2/show/NCT00931216.

背景

尽管抗逆转录病毒疗法在改善 HIV 感染者的健康和预防母婴传播（PMTCT）方面具有强有力的证据，但在撒哈拉以南非洲，HIV 仍然是一个主要的母婴健康问题。在大多数情况下，产前保健（ANC）服务和 HIV 治疗服务是在单独的诊所提供的。整合这些服务可能会导致更好地利用服务，减少开始治疗的时间，提高患者的依从性，并减少耻辱感。

方法/主要发现：本研究采用前瞻性整群随机对照试验设计，评估在肯尼亚农村政府卫生机构将 HIV 治疗纳入 ANC 诊所的效果。12 家机构被随机分为提供完全整合服务（ANC、PMTCT 和 HIV 治疗服务均在 ANC 诊所提供）或非整合服务（ANC 诊所提供 ANC 和基本 PMTCT 服务，并将患者转介到单独的 HIV 诊所进行 HIV 治疗）。在 2009 年 6 月至 2011 年 3 月期间，共有 1172 名 HIV 阳性孕妇入组该研究。主要研究结果是产妇接受 HIV 护理和治疗的比例、婴儿 HIV 检测率和 HIV 阴性婴儿的生存率。基线结果显示，干预组和对照组在社会人口统计学特征、男性伴侣 HIV 检测、夫妇血清不一致性、产科史、基线 CD4 计数和世界卫生组织（WHO）阶段方面相似。在资源匮乏的农村卫生机构开展这项试验时面临的挑战包括频繁的员工更替、基本用品短缺、交通挑战以及国家指南的变化。

结论/意义：这是在非洲农村地区进行的第一项关于 ANC 和 HIV 服务整合的随机试验。预计该研究将提供关于实施和有效性的关键证据，对努力消除垂直传播 HIV 和改善产妇健康的项目具有重要意义。