Linkage to Care -- Part I

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00703040

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
HIV

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase I

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	45
Study Start Date:	March 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Component 1 Existing linkage to care protocols will be obtained from the 15 sites. This component does not involve study subjects.
Component 2 Person-to-person or telephone interviews with ATN clinical site staff and staff from their community partners will be audio-taped.
Component 3 Notes from direct observation of the linkage to medical care process within sites will be taken.

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

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
University of Miami School of Medicine
Miami, Florida, United States, 33101
Childrens Diagnostic&Treatment Center
Fort Lauderdale, Florida, United States, 33316
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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Investigators

Study Chair:

J. Dennis Fortenberry, MD

Adolescent Trials Network

More Information

Adolescent Trials Network website This link exits the ClinicalTrials.gov site

Responsible Party:	Adolescent Trials Network ( J. Dennis Fortenberry, MD )
Study ID Numbers:	ATN 066a
Study First Received:	June 20, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00703040
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

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 15, 2009