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短信消息传递以提高肯尼亚预防母婴传播艾滋病毒(PMTCT)项目中的保留率和病毒抑制率:一项 3 臂随机临床试验。

SMS messaging to improve retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial.

机构信息

Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.

Department of Global Health, University of Washington, Seattle, Washington, United States of America.

出版信息

PLoS Med. 2021 May 24;18(5):e1003650. doi: 10.1371/journal.pmed.1003650. eCollection 2021 May.

Abstract

BACKGROUND

Pregnant and postpartum women living with HIV (WLWH) need support for HIV and maternal child health (MCH) care, which could be provided using short message service (SMS).

METHODS AND FINDINGS

We compared 2-way (interactive) and 1-way SMS messaging to no SMS in a 3-arm randomized trial in 6 MCH clinics in Kenya. Messages were developed using the Health Belief Model and Social Cognitive Theory; HIV messages were integrated into an existing MCH SMS platform. Intervention participants received visit reminders and prespecified weekly SMS on antiretroviral therapy (ART) adherence and MCH, tailored to their characteristics and timing. Two-way participants could message nurses as needed. Clinic attendance, viral load (VL), and infant HIV results were abstracted from program records. Primary outcomes were viral nonsuppression (VL ≥1,000 c/ml), on-time clinic attendance, loss to follow-up from clinical care, and infant HIV-free survival. Among 824 pregnant women randomized between November 2015 and May 2017, median age was 27 years, gestational age was 24.3 weeks, and time since initiation of ART was 1.0 year. During follow-up to 2 years postpartum, 9.8% of 3,150 VL assessments and 19.6% of women were ever nonsuppressed, with no significant difference in 1-way versus control (11.2% versus 9.6%, adjusted risk ratio (aRR) 1.02 [95% confidence interval (CI) 0.67 to 1.54], p = 0.94) or 2-way versus control (8.5% versus 9.6%, aRR 0.80 [95% CI 0.52 to 1.23], p = 0.31). Median ART adherence and incident ART resistance did not significantly differ by arm. Overall, 88.9% (95% CI 76.5 to 95.7) of visits were on time, with no significant differences between arms (88.2% in control versus 88.6% in 1-way and 88.8% in 2-way). Incidence of infant HIV or death was 3.01/100 person-years (py), with no significant difference between arms; risk of infant HIV infection was 0.94%. Time to postpartum contraception was significantly shorter in the 2-way arm than control. Study limitations include limited ability to detect improvement due to high viral suppression and visit attendance and imperfect synchronization of SMS reminders to clinic visits.

CONCLUSIONS

Integrated HIV/MCH messaging did not improve HIV outcomes but was associated with improved initiation of postpartum contraception. In programs where most women are virally suppressed, targeted SMS informed by VL data may improve effectiveness. Rigorous evaluation remains important to optimize mobile health (mHealth) interventions.

TRIAL REGISTRATION

ClinicalTrials.gov number NCT02400671.

摘要

背景

携带艾滋病毒的孕妇和产后妇女(WLWH)需要艾滋病毒和母婴健康(MCH)护理方面的支持,这可以通过短信服务(SMS)来提供。

方法和发现

我们在肯尼亚的 6 家 MCH 诊所进行了一项 3 臂随机试验,比较了双向(互动)和单向短信与无短信的效果。这些信息是使用健康信念模型和社会认知理论开发的;艾滋病毒信息被整合到现有的 MCH SMS 平台中。干预组参与者会收到访问提醒和每周关于抗逆转录病毒治疗(ART)依从性和 MCH 的预设短信,这些短信是根据他们的特点和时间量身定制的。双向参与者可以根据需要向护士发送短信。诊所就诊情况、病毒载量(VL)和婴儿 HIV 结果从项目记录中提取。主要结果是病毒未抑制(VL≥1000 c/ml)、按时就诊、因临床护理而失去随访以及婴儿 HIV 无存活。在 2015 年 11 月至 2017 年 5 月期间随机分配的 824 名孕妇中,中位年龄为 27 岁,妊娠周数为 24.3 周,开始接受 ART 治疗的时间为 1.0 年。在产后 2 年的随访中,3150 次 VL 评估中有 9.8%和 19.6%的女性出现过病毒未抑制,单向与对照组(11.2%比 9.6%,调整风险比(aRR)为 1.02[95%置信区间(CI)为 0.67 至 1.54],p=0.94)或双向与对照组(8.5%比 9.6%,aRR 为 0.80[95%CI 为 0.52 至 1.23],p=0.31)之间没有显著差异。手臂之间的 ART 依从性和新出现的 ART 耐药性中位数没有显著差异。总体而言,按时就诊的比例为 88.9%(95%CI 76.5%至 95.7%),各手臂之间没有显著差异(对照组为 88.2%,单向组为 88.6%,双向组为 88.8%)。婴儿 HIV 或死亡的发生率为每 100 人年(py)3.01,各手臂之间没有显著差异;婴儿 HIV 感染的风险为 0.94%。双向组与对照组相比,产后避孕的开始时间明显缩短。研究的局限性包括由于高病毒抑制率和就诊率,检测改善的能力有限,以及短信提醒与就诊时间的同步性不完美。

结论

整合的 HIV/MCH 信息并没有改善 HIV 结果,但与产后避孕的开始有关。在大多数女性病毒得到抑制的项目中,基于 VL 数据的有针对性的短信通知可能会提高效果。严格的评估仍然很重要,可以优化移动健康(mHealth)干预措施。

试验注册

ClinicalTrials.gov 编号 NCT02400671。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92a0/8186790/c3e2780163b2/pmed.1003650.g001.jpg

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