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Clinical Trials/NCT00489034
NCT00489034
Completed
Not Applicable

Drug Use and HIV-Infected Female Adolescents' Care Use

University of North Carolina, Chapel Hill5 sites in 1 country178 target enrollmentJuly 2003
ConditionsHIV Infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infection
Sponsor
University of North Carolina, Chapel Hill
Enrollment
178
Locations
5
Primary Endpoint
Engagement in Care among Index Participants
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2003
End Date
December 2010
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Engagement in Care among Index Participants

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (5)

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