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'HI-4-TU' Study: Health Improvement for Teen Ugandans Study

2019年5月15日 更新者:Johns Hopkins University

Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda

This randomized clinical trial is an adolescent focused implementation science study directed at improved social support and prevention of both HIV/STI's and subsequent unplanned pregnancies. The study population is pregnant adolescents who are attending antenatal care in Kampala, Uganda The acceptability and effectiveness of two enhanced peer lead, reproductive health promotion interventions compared to routine health care will be studied. The study participants will be individually randomized to one of three arms.

研究概览

详细说明

The overall goal of this research to test the acceptability and effectiveness of two enhanced adolescent friendly reproductive health prevention interventions versus current routine care. In each intervention group, 152 adolescent mothers will be randomized to either the enhanced group peer support education and counseling intervention or to the enhanced one-to-one (individual) peer support education and counseling group with a young, model, peer educator trained to deliver Reproductive Health Education and counseling messages, beginning during pregnancy (≥ 28 weeks) and followed up to 9 months postpartum or study end at or after 6 months (whichever comes first). The control group will consist of 215 adolescent mothers randomized to routine care as provided at Mulago hospital (or the designated health facility) where midwives deliver group sessions during antenatal and postpartum care visits as well as standard PMTCT services including routine opt-out HIV C&T and availability of partner C&T. Syphilis testing should also be routinely provided and treatment provided for infected pregnant mothers and their partners as per local standard of care.

The 3 groups will be enrolled with study visits at 3, 6 and 9 months post partum however the intervention groups (Arms 2 and 3) will have additional visits at 36 weeks Antepartum, delivery, 6 and 10 weeks postpartum, Quantitative baseline data will be collected on routine demographic characteristics, reproductive history, pregnancy intentions and sexual risk/perceptions and HIV/Sexually Transmitted Infection status.

研究类型

介入性

注册 (实际的)

486

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

    • Wakiso DIstrict
      • Kampala、Wakiso DIstrict、乌干达
        • MUJHU Care Ltd

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

15年 至 19年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Pregnant at ≥28 weeks of gestation
  • Agreeing to provide written informed consent to be screened for and take part in the study
  • Agreeing to provide adequate locator information with residence within 30 km
  • Agreeing to a home visit
  • Agreeing to come for follow up visits and to receive study follow up phone calls

Exclusion Criteria:

  • Serious illness or social conditions that would prevent adherence to study requirements
  • High risk pregnancy or fetal death in utero (with the exception of risk defined only by maternal age)

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
无干预:Routine Care
Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C&T and family planning C&T services on request.
实验性的:Routine Care plus group support
Routine Care plus enhanced group support
Routine Care plus enhanced group support, and peer education beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
实验性的:Routine Care plus individual support
Routine Care plus enhanced individual support
Routine Care plus individual peer education and support beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Composite measure of consistent condom-use and use of an effective family planning method method
大体时间:A comparison of this binary outcome will be conducted at one year.
A log-binomial regression model will be used to obtain the prevalence rate ratios.
A comparison of this binary outcome will be conducted at one year.
Incidence of any Sexually Transmitted Infection
大体时间:at one year
Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms.
at one year

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。

合作者

调查人员

  • 首席研究员:Florence Mirembe, MMED, PhD、MU-JHU Care Ltd

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 (实际的)

2016年3月30日

初级完成 (实际的)

2017年12月1日

研究完成 (实际的)

2017年12月30日

研究注册日期

首次提交

2016年7月20日

首先提交符合 QC 标准的

2016年7月22日

首次发布 (估计)

2016年7月27日

研究记录更新

最后更新发布 (实际的)

2019年5月17日

上次提交的符合 QC 标准的更新

2019年5月15日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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.

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