Engaging Care for HIV-infected Adolescent Females.

Drug Use and HIV-Infected Female Adolescents' Care Use

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Behavioral: Quantitative Interview; Behavioral: Ethnographic Interview; Behavioral: Gender Interview

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.

• Study Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Universtiy of Southern California
  • Florida
    • Miami, Florida, United States, 33101
      • University of Miami, School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stroger Hospital of Cook County
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	As assessed through the qualitative interviews for index and network participants.	Baseline, 6 months, 12 months, and 18 months
Sexual Risk Behaviors	As assessed through the qualitative interviews for index and network participants.	Baseline, 6 months, 12 months, and 18 months
Substance Use	As assessed through the qualitative interviews for index and network participants.	Baseline, 6 months, 12 months, and 18 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse and Alcoholism (NIAAA); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH)
• Investigators: Study Director: Lori Perez, Ph.D, Westat

Publications and helpful links

Helpful Links

• Adolescent Medicine Trials Network for HIV/AIDS Interventions Website

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 19, 2007
• First Submitted That Met QC Criteria: June 19, 2007
• First Posted (Estimate): June 21, 2007

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: HIV; adherence; risk behaviors; clinical care; adolescent females
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ATN 009; 1R01DA014706-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO