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临床试验/NCT01433185
NCT01433185已完成不适用

Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention

University of Washington1 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
388
试验地点
1
主要终点
Proportion of women who attend postnatal clinic within 6-8 weeks postpartum

研究概览

简要总结

Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age at least 18 years
  • report ability to read SMS
  • ≥ 28 weeks gestation or delivery at study clinic on day of enrollment
  • HIV positive women enrolled in the PMTCT program
  • have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
  • willing to receive SMS messages from the study
  • planning to remain in the study area (Nyanza province) for the duration of the study

排除标准

  • age less than 18 years old
  • women who share phones with partners but HIV status not disclosed to partners
  • intention to deliver at a non-study hospital

结局指标

主要结局

Proportion of women who attend postnatal clinic within 6-8 weeks postpartum

时间窗: 6-8 weeks after delivery

Proportion of infants tested for HIV by DNA PCR

时间窗: 6-8 weeks after delivery

次要结局

  • Maternal adherence to antiretroviral prophylaxis(Up to 8 weeks after delivery)
  • Infant adherence to antiretroviral prophylaxis(Up to 6 weeks after delivery)
  • Time to post-natal clinic return(Up to 8 weeks after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Odeny

Principal Investigator

University of Washington

研究点 (1)

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