Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV (SMS4PMTCT)
2015年1月19日 更新者:Thomas Odeny、University of Washington
Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention
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.
研究概览
研究类型
介入性
注册 (实际的)
388
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Nyanza
-
Kisumu、Nyanza、肯尼亚
- Kenya Medical Research Institute, Family AIDS Care and Education Services
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Text message (SMS)
Text messages sent to women before and after delivery
|
Text messages sent to women before and after delivery
其他名称:
|
|
无干预:Usual care (current standard of care)
Current standard of care for women enrolled in PMTCT programs
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Proportion of women who attend postnatal clinic within 6-8 weeks postpartum
大体时间:6-8 weeks after delivery
|
6-8 weeks after delivery
|
|
Proportion of infants tested for HIV by DNA PCR
大体时间:6-8 weeks after delivery
|
6-8 weeks after delivery
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Infant adherence to antiretroviral prophylaxis
大体时间:Up to 6 weeks after delivery
|
Up to 6 weeks after delivery
|
|
Time to post-natal clinic return
大体时间:Up to 8 weeks after delivery
|
Up to 8 weeks after delivery
|
|
Maternal adherence to antiretroviral prophylaxis
大体时间:Up to 8 weeks after delivery
|
Up to 8 weeks after delivery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Elizabeth A Bukusi, MBChB, MMed, MPH, PhD、Kenya Medical Research Institute
- 首席研究员:Thomas A Odeny, MBChB, MPH、University of Washington/Kenya Medical Research Institute
- 学习椅:R Scott McClelland, MD, MPH、University of Washington
- 学习椅:Craig R Cohen, MD, MPH、University of California, San Francisco
- 学习椅:Carol Camlin, PhD、University of California, San Francisco
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Odeny TA, Bukusi EA, Cohen CR, Yuhas K, Camlin CS, McClelland RS. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing. AIDS. 2014 Sep 24;28(15):2307-12. doi: 10.1097/QAD.0000000000000409.
- Odeny TA, Newman M, Bukusi EA, McClelland RS, Cohen CR, Camlin CS. Developing content for a mHealth intervention to promote postpartum retention in prevention of mother-to-child HIV transmission programs and early infant diagnosis of HIV: a qualitative study. PLoS One. 2014 Sep 2;9(9):e106383. doi: 10.1371/journal.pone.0106383. eCollection 2014.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年4月1日
初级完成 (实际的)
2013年7月1日
研究完成 (实际的)
2013年7月1日
研究注册日期
首次提交
2011年9月12日
首先提交符合 QC 标准的
2011年9月12日
首次发布 (估计)
2011年9月13日
研究记录更新
最后更新发布 (估计)
2015年1月21日
上次提交的符合 QC 标准的更新
2015年1月19日
最后验证
2015年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.