Engaging Care for HIV-infected Adolescent Females.

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT00489034
First received: June 19, 2007
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
HIV Infection
Behavioral: Quantitative Interview
Behavioral: Ethnographic Interview
Behavioral: Gender Interview

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use and HIV-Infected Female Adolescents' Care Use

Resource links provided by NLM:


Further study details as provided by Westat:

Primary Outcome Measures:
  • Engagement in Care among Index Participants [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
    Engagement in care will be operationalized as the number of clinic visits attended and will be assessed through the qualitative interviews.


Secondary Outcome Measures:
  • Medication Adherence [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
    As assessed through the qualitative interviews for index and network participants.

  • Sexual Risk Behaviors [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
    As assessed through the qualitative interviews for index and network participants.

  • Substance Use [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
    As assessed through the qualitative interviews for index and network participants.


Enrollment: 178
Study Start Date: July 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Index Participants
HIV-infected females, ages 13- 23 years, recruited from ATN sites in New York, Chicago, Miami, Los Angeles, and New Orleans will undergo quantitative interviewing. A sub-sample of the group will undergo ethnographic and/or gender interviewing.
Behavioral: Quantitative Interview
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.
Behavioral: Ethnographic Interview
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.
Behavioral: Gender Interview
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.
Network Participants
Closest friends of index participants s and parents/guardians of index participants who know the index participant's HIV status will undergo quantitative interviewing. A sub-sample of the group will undergo ethnographic interviewing.
Behavioral: Quantitative Interview
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.
Behavioral: Ethnographic Interview
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 23 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months will be followed to examine the correlation of substance use, mental health disorders, and social networks to engagement in care and suggested ways to promote adherence and retention in treatment, care, and prevention.
Criteria

Quantitative Study Inclusion Criteria

Index Participants:

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

Network Participants:

Parents/Guardians of Index Participants:

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

Close Friend of Index Participants:

  1. Close friend of index subject.
  2. Male or female.
  3. Minimum age 13 years, 0 months.
  4. All race/ethnicities
  5. English or Spanish speaking

Ethnographic Sub-Sample

Inclusion Criteria:

Index Participants:

  1. Enrolled in Quantitative NIDA study.
  2. English-speaking at Miami, New York, Chicago, and New Orleans sites.
  3. English or Spanish-speaking at Los Angeles USC site

Network Participants:

  1. English-speaking at Miami, New York, Chicago, and New Orleans sites.
  2. English or Spanish-speaking at Los Angeles USC site.
  3. Know index serostatus.

Gender Sub-Sample

Inclusion Criteria:

  1. Age 18 years, 0 months - 23 years, 11 months.
  2. Enrolled in quantitative study.
  3. English-speaking.
  4. Female.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489034

Locations
United States, California
Universtiy of Southern California
Los Angeles, California, United States, 90033
United States, Florida
University of Miami, School of Medicine
Miami, Florida, United States, 33101
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Westat
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Lori Perez, Ph.D Westat
  More Information

Additional Information:
Responsible Party: Westat
ClinicalTrials.gov Identifier: NCT00489034     History of Changes
Other Study ID Numbers: ATN 009  1RO1DA14706-01 
Study First Received: June 19, 2007
Last Updated: August 1, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Westat:
HIV
adolescent females
adherence
clinical care
risk behaviors

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 30, 2016