An observational study in HIV Infection, sponsored by University of North Carolina, Chapel Hill. Completed at 5 sites in United States. Open to female participants aged 13 Years to 23 Years. Per ClinicalTrials.gov, last updated 2017-03-06.
Sponsored by University of North Carolina, Chapel Hill · Observational
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 178 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
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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.
Quantitative Study Inclusion Criteria
Index Participants:
Network Participants:
Parents/Guardians of Index Participants:
Close Friend of Index Participants:
Ethnographic Sub-Sample
Inclusion Criteria:
Index Participants:
Network Participants:
Gender Sub-Sample
Inclusion Criteria:
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 · Behavioral: Ethnographic Interview · Behavioral: Gender 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.
Behavioral: Quantitative Interview · Behavioral: Ethnographic 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.
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.
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.
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
Medication Adherence
As assessed through the qualitative interviews for index and network participants.
Time frame: Baseline, 6 months, 12 months, and 18 months
Sexual Risk Behaviors
As assessed through the qualitative interviews for index and network participants.
Time frame: Baseline, 6 months, 12 months, and 18 months
Substance Use
As assessed through the qualitative interviews for index and network participants.
Time frame: Baseline, 6 months, 12 months, and 18 months
Plan to share: No
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill