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Completed

NCT Number: NCT00489034

Engaging Care for HIV-infected Adolescent Females.

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.

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Key information

Conditions

HIV Infection Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Risk-Taking Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

13 year–23 year

Sex eligibility

Female

Study type

Observational

Primary location

Universtiy of Southern California, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Quantitative Study Inclusion Criteria

Index Participants:

  • Female.
  • Age 13 years, 0 months - 23 years, 11 months (364 days).
  • All race/ethnicities.
  • English or Spanish speaking.
  • Non-perinatal, non-transfusion acquired HIV.
  • Unknown transmission status with study personnel approval.

Network Participants:

Parents/Guardians of Index Participants:

  • Know patient's HIV status
  • Male or female.
  • All race/ethnicities
  • English or Spanish speaking.
  • Serve a parental or guardian-like role.

Close Friend of Index Participants:

  • Close friend of index subject.
  • Male or female.
  • Minimum age 13 years, 0 months.
  • All race/ethnicities
  • English or Spanish speaking

Ethnographic Sub-Sample

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

  • Age 18 years, 0 months - 23 years, 11 months.
  • Enrolled in quantitative study.
  • English-speaking.
  • Female.

Treatment and study plan

Quantitative Interview

Behavioral

Index participants will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for 18 months while network members will be interviewed at baseline and one year. Interviews will consist of in-depth face-to-face and audio computer-assisted interviews (ACASIs) and a structured diagnostic interview to assess engagement in care (number of clinical visits attended), substance use, attitudes about substance use, friend's substance use, sexual risk behaviors, PTSD (for index participants only), support of index participants care use (network participants only), attitudes about healthcare (network participants only), index participant's adherence (network participants only), own functioning (network participants only), and family functioning (network participants only). At Baseline only, a urine sample will be collected from index participants for drug testing to assess the agreement between urine and ACASI.

Ethnographic Interview

Behavioral

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

Gender Interview

Behavioral

Qualitative interviews will be conducted with a sub-sample of index participants. These interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey.

Primary outcomes

  1. 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

  1. Medication Adherence

    Time frame: Baseline, 6 months, 12 months, and 18 months

    As assessed through the qualitative interviews for index and network participants.

  2. Sexual Risk Behaviors

    Time frame: Baseline, 6 months, 12 months, and 18 months

    As assessed through the qualitative interviews for index and network participants.

  3. Substance Use

    Time frame: Baseline, 6 months, 12 months, and 18 months

    As assessed through the qualitative interviews for index and network participants.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Drug Use and HIV-Infected Female Adolescents' Care Use

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Jun 21, 2007
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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