Behavioral Intervention for Minority Adolescent Women
The purpose of this Stage II clinical trial is to test the efficacy of a culturally sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging contraceptive use.
Its primary goal is to expand risk-reduction interventions created in previous studies to further increase intervention efficacy for this particularly vulnerable, high-risk group.
An adolescent intervention has been created and pilot tested in developmental studies.
Results indicated reductions in substance use, risk behaviors, unintended pregnancy, STI and abuse without reports of adverse outcomes.
Specific aims of the current study include: 1) To obtain a more in-depth understanding of configurations of psychosocial and situational factors associated with high-risk sexual behavior, substance use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To implement a controlled randomized trial of a cognitive behavioral risk-reduction intervention consisting of 2 small group sessions, 2 individual counseling and 3 support groups for this group; 3) To evaluate the effects of the adolescent intervention model versus enhanced counseling for this group on AIDS Risk Reduction Model (ARRM)-related constructs, high-risk sexual behavior, substance use, abuse recurrence, contraceptive use, unintended pregnancy and STI/HIV at 6 and 12 months follow-up.
Participants will include a convenience sample of 600 Mexican-and African American adolescent women, aged 14-18 years with a history of sexual or physical abuse and current STI.
研究概览
详细说明
African-and Mexican-American adolescent women with a current STI and history of abuse will be identified at public health and STI clinics within the San Antonio Metropolitan Health District system.
Women who agree to participate and give informed consent will be randomized into the intervention or control arm.
Women in the control arm will be interviewed at baseline, be given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and will receive abuse and enhanced clinical counseling.
Women in the intervention arm will be interviewed at baseline, given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and enrolled in the intervention.
Women in the intervention arm will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline.
All women in the study will be followed over one year, with follow-up interviews including an inquiry about any Adverse Events (AEs) or Serious Adverse Events (SAEs), and a targeted physical exams and contraception counseling at 6 and 12 months.
During the study period, women will be encouraged to return to the study clinic for problem visits if they suspect they have been infected with a STI or require contraception or abuse counseling.
All analyses of intervention effects will be performed on an intent-to-treat basis.
研究类型
介入性
注册 (实际的)
562
阶段
- 阶段2
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
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Texas
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San Antonio、Texas、美国
- San Antonio Metropolitan Health District
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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
14年 至 18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:
- Aged 14-18 years, Mexican-or African-American female with a history of STI or abuse seeking health care through the San Antonio Metropolitan Health District.
Exclusion Criteria:
- No history of STI or abuse
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:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:Control Group
Participants in the control arm will be interviewed at baseline, be given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and will receive abuse and enhanced clinical counseling
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Participants in the intervention arm will be interviewed at baseline, given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and enrolled in the intervention.
The intervention will include 2 workshops, 5 support groups sessions and 2 individual counseling sessions.
They will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline.
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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 |
|---|---|---|
|
Sexually transmitted infection
大体时间:12 months
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Infection at 12 months with either chlamydia or gonorrhea
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Substance Use
大体时间:12 months
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Frequency and type of substance use
|
12 months
|
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Experience of abuse
大体时间:12 months
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Type and frequency of experience of abuse
|
12 months
|
|
Unintended pregnancy
大体时间:12 months
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Frequency of unintended pregnancy
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12 months
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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。
调查人员
- 首席研究员:Jane D Champion, PhD、The University of Texas Health Science Center at San Antonio
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Collins JL, Owen DC, Champion JD. The Meaning of Weight: A Big Way of Life for Rural Mexican-American Adolescent Men and Caregivers. Public Health Nurs. 2016 Sep;33(5):421-9. doi: 10.1111/phn.12263. Epub 2016 Apr 14.
- Collins JL, Champion JD. Assessment of mobile device and SMS Use for Diet and Exercise Information Among Rural Mexican-American adolescents. J Pediatr Nurs. 2014 Nov-Dec;29(6):493-502. doi: 10.1016/j.pedn.2014.03.020. Epub 2014 Mar 15.
- Dimmitt Champion J, Harlin B, Collins JL. Sexual risk behavior and STI health literacy among ethnic minority adolescent women. Appl Nurs Res. 2013 Nov;26(4):204-9. doi: 10.1016/j.apnr.2013.06.003. Epub 2013 Jul 15.
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
2004年10月1日
初级完成 (实际的)
2009年4月1日
研究完成 (实际的)
2009年4月1日
研究注册日期
首次提交
2011年6月30日
首先提交符合 QC 标准的
2011年7月1日
首次发布 (估计)
2011年7月4日
研究记录更新
最后更新发布 (估计)
2011年7月4日
上次提交的符合 QC 标准的更新
2011年7月1日
最后验证
2011年6月1日
更多信息
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.