Engaging Care for HIV-Infected Adolescent Females.
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 19, 2007 | ||||
| Last Updated Date | June 19, 2007 | ||||
| Start Date ICMJE | July 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Engaging Care for HIV-Infected Adolescent Females. | ||||
| Official Title ICMJE | Drug Use and HIV-Infected Female Adolescents' Care Use | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | HIV Infection | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | QUALITATIVE STUDY (1): ETHNOGRAPHIC STUDY ELIGIBILITY Study Eligibility: In-depth Interviews • Index Participants
Inclusion/ Exclusion Criteria: Inclusion
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
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| Gender | Female | ||||
| Ages | 18 Years to 23 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00489034 | ||||
| Other Study ID Numbers ICMJE | ATN 009, 1RO1DA14706-01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | March 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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