ClinicalTrials.gov
ClinicalTrials.gov Menu

Linkage to Care - Part I

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00703040
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This first phase of a two-phase study involves three components:

  1. Review of existing linkage-to-care protocols and sources of referrals for care;
  2. 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
  3. Structured observations of referral sessions.

Condition or disease
HIV

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase I
Study Start Date : March 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Describe and evaluate community screening standards and practices. [ Time Frame: 1 year ]
  2. Describe and evaluate the relationships of screening venues with care-providing venues. [ Time Frame: 1 year ]
  3. Describe and evaluate referral and intake protocols. [ Time Frame: 1 year ]
  4. Describe and evaluate care adherence support (including support from both clinical and non-clinical sources). [ Time Frame: 1 year ]

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): 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
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
Study Chair: J. Dennis Fortenberry, MD Adolescent Trials Network
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00703040     History of Changes
Other Study ID Numbers: ATN 066a
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2016

Keywords provided by University of North Carolina, Chapel Hill:
Care engagement
Linkage to care
HIV Infections