Engaging Care for HIV-infected Adolescent Females.
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ClinicalTrials.gov Identifier: NCT00489034 |
Recruitment Status
:
Completed
First Posted
: June 21, 2007
Last Update Posted
: March 6, 2017
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Condition or disease | Intervention/treatment |
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HIV Infection | Behavioral: Quantitative Interview Behavioral: Ethnographic Interview Behavioral: Gender Interview |
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 |
Actual Enrollment : | 178 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Drug Use and HIV-Infected Female Adolescents' Care Use |
Study Start Date : | July 2003 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Group/Cohort | Intervention/treatment |
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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.
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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.
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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.
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- Engagement in Care among Index Participants [ Time Frame: 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.
- Medication Adherence [ Time Frame: Baseline, 6 months, 12 months, and 18 months ]As assessed through the qualitative interviews for index and network participants.
- Sexual Risk Behaviors [ Time Frame: Baseline, 6 months, 12 months, and 18 months ]As assessed through the qualitative interviews for index and network participants.
- Substance Use [ Time Frame: Baseline, 6 months, 12 months, and 18 months ]As assessed through the qualitative interviews for index and network participants.

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Ages Eligible for Study: | 13 Years to 23 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Quantitative Study Inclusion Criteria
Index Participants:
- Female.
- Age 13 years, 0 months - 23 years, 11 months (364 days).
- All race/ethnicities.
- English or Spanish speaking.
- Non-perinatal, non-transfusion acquired HIV.
- Unknown transmission status with study personnel approval.
Network Participants:
Parents/Guardians of Index Participants:
- Know patient's HIV status
- Male or female.
- All race/ethnicities
- English or Spanish speaking.
- Serve a parental or guardian-like role.
Close Friend of Index Participants:
- Close friend of index subject.
- Male or female.
- Minimum age 13 years, 0 months.
- All race/ethnicities
- English or Spanish speaking
Ethnographic Sub-Sample
Inclusion Criteria:
Index Participants:
- Enrolled in Quantitative NIDA study.
- English-speaking at Miami, New York, Chicago, and New Orleans sites.
- English or Spanish-speaking at Los Angeles USC site
Network Participants:
- English-speaking at Miami, New York, Chicago, and New Orleans sites.
- English or Spanish-speaking at Los Angeles USC site.
- Know index serostatus.
Gender Sub-Sample
Inclusion Criteria:
- Age 18 years, 0 months - 23 years, 11 months.
- Enrolled in quantitative study.
- English-speaking.
- Female.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489034
United States, California | |
Universtiy of Southern California | |
Los Angeles, California, United States, 90033 | |
United States, Florida | |
University of Miami, School of Medicine | |
Miami, Florida, United States, 33101 | |
United States, Illinois | |
Stroger Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
Tulane Medical Center | |
New Orleans, Louisiana, United States, 70112 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Study Director: | Lori Perez, Ph.D | Westat |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00489034 History of Changes |
Other Study ID Numbers: |
ATN 009 1R01DA014706-01 ( U.S. NIH Grant/Contract ) |
First Posted: | June 21, 2007 Key Record Dates |
Last Update Posted: | March 6, 2017 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by University of North Carolina, Chapel Hill:
HIV adolescent females adherence clinical care risk behaviors |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |