Engaging Care for HIV-infected Adolescent Females.

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infection

Treatments: Behavioral: Ethnographic Interview; Behavioral: Gender Interview; Behavioral: Quantitative Interview

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00489034

ATN 009

1R01DA014706-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: Female

Ages: 13 to 23 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

178 participants in 2 patient groups

Index Participants

Description:

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.

Treatment:

Behavioral: Gender Interview

Behavioral: Quantitative Interview

Behavioral: Ethnographic Interview

Network Participants

Description:

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.

Treatment:

Behavioral: Quantitative Interview

Behavioral: Ethnographic Interview