Linkage to Care - Part II
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|ClinicalTrials.gov Identifier: NCT00891644|
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment|
|HIV Care-seeking HIV Infections||Other: Case Management Other: Snowball sampling Other: Referral Lists|
ATN 066b consists of a cross-sectional evaluation of three groups of recently diagnosed HIV-infected adolescents including: (1) care non-initiation; (2) care initiation, no maintenance; and (3) care initiation with maintenance. Social, psychological and behavioral factors associated with HIV-related care-seeking will be assessed using an ACASI. Three recruitment strategies using a randomized permuted block list of possible sequences for HIV-infected youth not in care will be also compared.
The ACASI instrument will be adapted from previously used instruments intended to retrospectively reconstruct the care-seeking process and to assess quality of life, concerns and expectations for care, satisfaction with care, and social-problem solving.
Ideally, the ACASI will be administered during a single session and may take up to 90 minutes to complete. Participants who are unable to complete the ACASI in one session will be allowed up to 7 days after initiation to complete it. Completion of all study data collection, including accrual period, is expected to take approximately 12 months. Outcome measures will be classified as (1) care non-initiation; (2) care initiation, no maintenance; or (3) care initiation and maintenance.
The assessment of recruitment strategies most effective for not in care youth will include: use of usual case-management approaches; snowball sampling and venue-based advertisement.
|Study Type :||Observational|
|Actual Enrollment :||59 participants|
|Official Title:||HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase II|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
HIV positive adolescents who never initiated care within 6 months of receipt of HIV positive results.
Other: Case Management
Clinical personnel at each AMTU site may work with other personnel from organizations authorized to have access to personal health information to identify clients identified as HIV positive within the past 6 - 18 months.
Initial contact will be made by persons at source organizations who are authorized to have access to personal health information. Persons so authorized will explain the nature of the research study and request permission from the client for subsequent contact by research personnel from the AMTU site. If permission for contact is received, research personnel at each site will attempt calls as specified by the potential participant or at random times (before 12:00 pm; between 12:00 - 4:00 pm; and between 4:00 - 10:00 pm) for no more than 10 attempts.
Other: Snowball sampling
Snowball sampling assumes that social networks of HIV sero-positive persons in treatment may overlap with those of HIV sero-positive persons not in treatment.
When a site is assigned to identify HIV positive adolescents not in care by snowball sampling, all HIV positive persons in care at the site will be invited to refer other adolescents known to them as HIV positive, but not in care, for possible participation in the study.
Printed information containing a brief description of the research in English and in Spanish and contact information of site study personnel will be provided to in-care adolescents at the site for distribution to those known HIV positive adolescents who are not in care.
HIV positive adolescents who initiated care, but did not follow up with care within 12 months of the initial care visit. Also included in this group are those who initiated and followed-up with care, but have dropped out of care for 12 or more months.
Other: Referral Lists
AMTU staff will develop lists of potential participants at their sites who have had an initial HIV-related health care visit but not received additional visits within the 12 mos prior the list (or before protocol screening) or have completed initial and follow up visits but dropped out of care for 12 or more mos. Back-up lists will be made of potential participants who have gone 9-12 mos and 6-9 mos without a visit. Clinical staff at each AMTU may work with staff from other organizations authorized to access personal health information to find potential participants. 1st contact will be made by persons at source organizations who are authorized to access personal health information. Authorized staff will explain the study and ask permission for contact by research staff at the AMTU site. If so, research staff will attempt calls as specified by the potential participant or at random (before 12 pm; between 12-4 pm; and between 4-10 pm) for no more than 10 attempts.
HIV positive adolescents who initiated care and maintained care. These youth are currently in care.
- Retrospectively recreate the process and timeline of care-seeking among screened HIV positive adolescents. [ Time Frame: 1 year ]
- Evaluate technical aspects of identification and recruitment of HIV positive adolescents who have not engaged in care or who have not maintained care. [ Time Frame: 1 year ]
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): NCT00891644
|United States, California|
|Children's Hopsital of Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Florida|
|Children's Diagnostic and Treatment Center|
|Fort Lauderdale, Florida, United States, 33316|
|United States, Illinois|
|Childrens Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|United States, New York|
|Children's Hospital at Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|United States, Pennsylvania|
|Children's Hopsital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Dennis Fortenberry, MD||Adolescent Trials Network|