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临床试验/NCT03023033
NCT03023033已完成不适用

Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania

Elizabeth Glaser Pediatric AIDS Foundation1 个研究点 分布在 1 个国家目标入组 1,505 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,505
试验地点
1
主要终点
Early identification of HEI at Reproductive and Child Health (RCH) Clinic

研究概览

简要总结

The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.

详细描述

Following a formative phase I, we propose in phase II to implement a three-group cluster-randomized study to test the effectiveness of short message service (SMS) reminders and notifications, [mobile health or mhealth] (group 1) and the combined effectiveness of SMS reminders/notifications and cash transfers (group 2) compared to the standard prevention of mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH) practices (group 3).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC
  • Plans to deliver in facility catchment area
  • 18 years or older
  • Able and willing to provide consent

排除标准

  • 未提供

研究组 & 干预措施

Clinic group 3

No Intervention

Services provided under the Ministry of Health standard care

Clinic group 2

Experimental

Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)

干预措施: Transport Payments (Behavioral)

Clinic group 1

Experimental

Clinics using SMS health promotion and reminder messages (mhealth messaging)

干预措施: mHealth messaging (Behavioral)

结局指标

主要结局

Early identification of HEI at Reproductive and Child Health (RCH) Clinic

时间窗: 1 year

Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic

Antenatal care (ANC) visits

时间窗: 1 year

Proportion of pregnant women attending at least 4 ANC visits

Facility delivery

时间窗: 1 year

Proportion of pregnant women delivering in a health facility

Post natal care (PNC) visits

时间窗: 1 year

Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery

Nevirapine (NVP) at delivery

时间窗: 1 year

Proportion of HEI given NVP at delivery

Attendance for Early infant diagnosis (EID) of HIV

时间窗: 1 year

Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks

次要结局

  • Receipt of EID results(1 year)
  • Time to receipt of EID results(1 year)
  • Time to treatment(! year)
  • HIV infected infants initiated on antiretroviral therapy (ART)(1 year)
  • Time to EID(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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