Engaging Care for HIV-infected Adolescent Females.

HIV Infection Clinical Trial

Official title:

Drug Use and HIV-Infected Female Adolescents' Care Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489034
• Other study ID #: ATN 009
• Secondary ID: 1R01DA014706-01
• Status: Completed
• Phase: N/A
• First received: June 19, 2007
• Last updated: March 2, 2017
• Start date: July 2003
• Est. completion date: December 2010

Study information

• Verified date: August 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 23 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Universtiy of Southern California	Los Angeles	California
United States	University of Miami, School of Medicine	Miami	Florida
United States	Tulane Medical Center	New Orleans	Louisiana

Sponsors (5)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	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)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in Care among Index Participants	Engagement in care will be operationalized as the number of clinic visits attended and will be assessed through the qualitative interviews.	Baseline, 6 months, 12 months, and 18 months
Secondary	Medication Adherence	As assessed through the qualitative interviews for index and network participants.	Baseline, 6 months, 12 months, and 18 months
Secondary	Sexual Risk Behaviors	As assessed through the qualitative interviews for index and network participants.	Baseline, 6 months, 12 months, and 18 months
Secondary	Substance Use	As assessed through the qualitative interviews for index and network participants.	Baseline, 6 months, 12 months, and 18 months

External Links

•   Adolescent Medicine Trials Network for HIV/AIDS Interventions Website