Engaging Care for HIV-infected Adolescent Females.

Completed

• Conditions: HIV Infection
• Interventions: Behavioral: Quantitative Interview; Behavioral: Ethnographic Interview; Behavioral: Gender Interview

• Registration Number: NCT00489034
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-21
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-08
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 178

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Index Participants	Gender Interview	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.
Index Participants	Quantitative Interview	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.
Network Participants	Ethnographic Interview	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.
Index Participants	Ethnographic Interview	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.
Network Participants	Quantitative Interview	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.

Primary Outcome Measures

Name	Time	Method
Engagement in Care among Index Participants	Baseline, 6 months, 12 months, and 18 months	Engagement in care will be operationalized as the number of clinic visits attended and will be assessed through the qualitative interviews.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Universtiy of Southern California; 🇺🇸 Los Angeles, California, United States

University of Miami, School of Medicine; 🇺🇸 Miami, Florida, United States

Stroger Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Tulane Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States