Linkage to Care - Part I
This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00703040
First received: June 20, 2008
Last updated: February 12, 2015
Last verified: December 2014
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Purpose
This first phase of a two-phase study involves three components:
- Review of existing linkage-to-care protocols and sources of referrals for care;
- Semi-structured telephone or face-to-face interviews with a minimum of two personnel per site who are associated with linkage to medical care. (Preference will be given to personnel with direct experience in linkage to care); and
- Structured observations of referral sessions.
| Condition |
|---|
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HIV |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase I |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Describe and evaluate community screening standards and practices. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Describe and evaluate the relationships of screening venues with care-providing venues. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Describe and evaluate referral and intake protocols. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Describe and evaluate care adherence support (including support from both clinical and non-clinical sources). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | March 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Component 1
Existing linkage to care protocols will be obtained from the 15 sites. This component does not involve study subjects.
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Component 2
Person-to-person or telephone interviews with ATN clinical site staff and staff from their community partners will be audio-taped.
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Component 3
Notes from direct observation of the linkage to medical care process within sites will be taken.
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Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Component 1: The object of study is a collection of documents on existing linkage-to-care protocols and does not constitute a population. Component 2: Ideally, a minimum of two clinical staff and/or case managers from each of 15 AMTU and a minimum of one staff member representing the AMTU's community partners/sites where linkage to care activities occur. Component 3- Structured Observations: Clinical site staff providing linkage to care counseling. Please note that patients are not part of this study population. See Section 5.3 and Section 10.0 for additional details.
Criteria
Inclusion Criteria:
- Component 1: Documents identified by clinical site personnel as pertaining to post-test counseling, linkage to care, or standard operating procedures addressing post-test counseling and linkage to care.
- Component 2: Persons employed by one of the AMTUs or an identified linkage-to-care partner and work as clinical staff or a case-manager or is a person familiar to linkage to care; or persons involved in posttest counseling and linkage-to-care processes. Clinical staff and case managers are chosen based on direct experience in the assistance of HIV seropositive youth obtaining medical care. This definition includes, but is not limited to, physicians, nurses, psychologists, social workers, and case managers (who may have diverse professional backgrounds).
- Component 3: All AMTU sites will be included.
Exclusion Criteria:
- Component 1: No a priori exclusions.
- Component 2: No a priori exclusions.
- Component 3: No a priori exclusions.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703040
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703040
Locations
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| Childrens Diagnostic&Treatment Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33101 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Mount Sinai Medical Center | |
| Manhattan, New York, United States, 10128 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| St. Jude Childrens Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
Sponsors and Collaborators
Investigators
| Study Chair: | J. Dennis Fortenberry, MD | Adolescent Trials Network |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00703040 History of Changes |
| Other Study ID Numbers: | ATN 066a |
| Study First Received: | June 20, 2008 |
| Last Updated: | February 12, 2015 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Care engagement Linkage to care HIV Infections |
ClinicalTrials.gov processed this record on February 25, 2015