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临床试验/NCT01643005
NCT01643005已完成不适用

Pilot Phase of Couples-Based Intervention to Reduce HIV/STD Risk (Concurrency, Number of Partners, Unprotected Sex), Strengthen Relationships, and Improve Parenting Among Young Parenting Heterosexual Couples

Yale University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
High risk sexual behavior

研究概览

简要总结

This study seeks to develop, implement, and assess an innovative 15-session couple-based intervention to be delivered in a group format to young parents that aims to strengthen relationships and reduce HIV risk. The ultimate goal of our intervention is to reduce HIV/STD risk (concurrency, number of partners, unprotected sex), strengthen relationships, and improve parenting among young parenting heterosexual couples.

详细描述

This study develops a couple-based HIV prevention intervention that is innovative and important because it integrates an intervention that improves sexual health, relationship functioning, and parenting skills. Our intervention will be integrated with an existing community based parenting program. By targeting high risk heterosexual couples experiencing an important life transition that increases their stress, conflict, and sexual risk, the investigators can provide maximum benefit to the men, women, and children in our communities. Using the guiding framework of Attachment Theory and the principles of Emotion Focused Therapy, the investigators will directly address issues of emotion, intimacy,and relationship functioning to create an intervention that strengthens romantic relationships and reduces HIV risk behavior. The investigators will conduct a small pilot randomized controlled trial of 50 parenting couples randomized to either the relationship strengthening HIV prevention intervention or an active control. The intervention will last 15 weeks and each session will be approximately 1.5 hours long. The investigators will assess couples at baseline, 4-months, and 8-months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women's age between 14 and 25
  • Men's age 14 or older
  • Have a child that is 0-1 year old
  • In a romantic relationship with the mother/father of the baby
  • Not known to be HIV positive
  • English speaking

排除标准

  • Child older than 1 year
  • HIV positive

结局指标

主要结局

High risk sexual behavior

时间窗: 8 months

Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

次要结局

  • Relationship Functioning at 4 months(4 months)
  • Relationship Dissolution at 4 months(4 months)
  • Change from Baseline in relationship based determinants at 4 months(4 months)
  • Relationship Functioning at 8 months(8 months)
  • Relationship Dissolution at 8 months(8 months)
  • Change from Baseline in relationship based determinants at 8 months(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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