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临床试验/NCT00489034
NCT00489034已完成不适用

Drug Use and HIV-Infected Female Adolescents' Care Use

University of North Carolina, Chapel Hill5 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2003年7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
178
试验地点
5
主要终点
Engagement in Care among Index Participants

研究概览

简要总结

The proposed multi-site, longitudinal study will examine the correlation of substance use, mental health disorders, and social networks to engagement in care for HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months, and suggest ways to promote adherence and retention in treatment, care, and prevention programs. Qualitative and quantitative data collection methods will be used with index participants and network members.

详细描述

The primary outcome examined in the proposed study is engagement in care, operationalized as the number of clinical visits attended. Clinic visits will be monitored on a weekly basis. Secondary outcomes of interest include medication adherence, sexual risk behaviors, and substance use. For the quantitative study, formal psychological testing will be conducted with index adolescent females, and biological specimens will be collected to validate self-reported drug use. CD-4 counts and viral load will be monitored every three months via chart review.

Index adolescents will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for eighteen months while network members will be interviewed at baseline and one year.

Qualitative interviews in the Ethnographic Study will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of at least 18 months. Qualitative interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and to guide their progression.

Qualitative Interviews in the Gender Substudy will be conducted with a subsample of index participants. These qualitative interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey to be administered to all index participants from sites participating in this substudy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 23 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Index Participants:
  • Enrolled in Quantitative NIDA study.
  • English-speaking at Miami, New York, Chicago, and New Orleans sites.
  • English or Spanish-speaking at Los Angeles USC site
  • Network Participants:
  • English-speaking at Miami, New York, Chicago, and New Orleans sites.
  • English or Spanish-speaking at Los Angeles USC site.
  • Know index serostatus.
  • Gender Sub-Sample
  • Inclusion Criteria:
  • Age 18 years, 0 months - 23 years, 11 months.
  • Enrolled in quantitative study.
  • English-speaking.

排除标准

  • 未提供

结局指标

主要结局

Engagement in Care among Index Participants

时间窗: Baseline, 6 months, 12 months, and 18 months

Engagement in care will be operationalized as the number of clinic visits attended and will be assessed through the qualitative interviews.

次要结局

  • Substance Use(Baseline, 6 months, 12 months, and 18 months)
  • Medication Adherence(Baseline, 6 months, 12 months, and 18 months)
  • Sexual Risk Behaviors(Baseline, 6 months, 12 months, and 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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