Clinical trial NCT00489034: Engaging Care for HIV-infected Adolescent Females.
Official title: Drug Use and HIV-Infected Female Adolescents' Care Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
adolescent females
adherence
clinical care
risk behaviors
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Drug Abuse (NIDA)
First posted: 2007-06-21
Enrollment: 178
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Engagement in Care among Index Participants
timeFrame: Baseline, 6 months, 12 months, and 18 months
Secondary outcomes:
measure: Medication Adherence
timeFrame: Baseline, 6 months, 12 months, and 18 months
measure: Sexual Risk Behaviors
timeFrame: Baseline, 6 months, 12 months, and 18 months
measure: Substance Use
timeFrame: Baseline, 6 months, 12 months, and 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Universtiy of Southern California
state: California
city: Miami
country: United States
facility: University of Miami, School of Medicine
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Westat
name: Lori Perez, Ph.D
role: STUDY_DIRECTOR
References: