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临床试验/NCT02845284
NCT02845284已完成不适用

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

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 486 人开始时间: 2016年3月30日最近更新:
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
486
试验地点
1
主要终点
Composite measure of consistent condom-use and use of an effective family planning method method

研究概览

简要总结

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.

详细描述

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
15 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Routine Care

No Intervention

Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C&T and family planning C&T services on request.

Routine Care plus group support

Experimental

Routine Care plus enhanced group support

干预措施: enhanced group support (Behavioral)

Routine Care plus individual support

Experimental

Routine Care plus enhanced individual support

干预措施: enhanced individual support (Behavioral)

结局指标

主要结局

Composite measure of consistent condom-use and use of an effective family planning method method

时间窗: 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.

Incidence of any Sexually Transmitted Infection

时间窗: at one year

Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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