'HI-4-TU' Study: Health Improvement for Teen Ugandans Study
Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Wakiso DIstrict
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Kampala、Wakiso DIstrict、乌干达
- MUJHU Care Ltd
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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.
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实验性的:Routine Care plus group support
Routine Care plus enhanced group support
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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.
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实验性的:Routine Care plus individual support
Routine Care plus enhanced individual support
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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.
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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.
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A log-binomial regression model will be used to obtain the prevalence rate ratios.
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A comparison of this binary outcome will be conducted at one year.
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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.
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at one year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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