Engaging Care for HIV-Infected Adolescent Females.
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
HIV Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal |
| Official Title: | Drug Use and HIV-Infected Female Adolescents' Care Use |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 23 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
QUALITATIVE STUDY (1): ETHNOGRAPHIC STUDY ELIGIBILITY
Study Eligibility: In-depth Interviews
• Index Participants
- Approximately 10 index participants between the ages of 18 years, 0 months and 23 years, 11 months will be recruited for in-depth interviews at the substudy sites.
- Their selection need not be random; however, they should be participants who are enrolled already in the quantitative study.
- Index participants who are involved in the ethnographic study are eligible to participate in the gender substudy interviews also, if they wish.
Inclusion/ Exclusion Criteria: Inclusion
- Age 18 years, 0 months - 23 years, 11 months
- Enrolled in quantitative study
- English-speaking
SURVEY
Following initial development supported by in-depth interviews, the survey assessing gender vulnerability will be introduced as an additional instrument to be administered to all index participants in the quantitative study during the 12-month or 18-month quantitative study visit for index participants at New York, Miami, and Chicago, and at the 6-month or 12-month quantitative study visit for index participants at New Orleans.
Study Eligibility: Survey
• Index Participants
Index participants who are between the ages of 18 years, 0 months and 23 years, 11 months and who are enrolled in the quantitative study will be eligible to complete the gender survey. The survey will be introduced at the 12-month or 18-month study visit of the quantitative study in New York, Miami, and Chicago, and at the 6-month or 12-month quantitative study visit for index participants at New Orleans.
Inclusion/ Exclusion Criteria: Inclusion
- Age 18 years, 0 months - 23 years, 11 months
- Enrolled in quantitative study
- English-speaking
- Female
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00489034 History of Changes |
| Other Study ID Numbers: | ATN 009, 1RO1DA14706-01 |
| Study First Received: | June 19, 2007 |
| Last Updated: | June 19, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
HIV adolescent females adherence clinical care risk behaviors |
ClinicalTrials.gov processed this record on February 27, 2015