NCT00703040

Brief Summary

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

June 20, 2008

Last Update Submit

February 27, 2017

Conditions

Keywords

Care engagementLinkage to careHIV Infections

Outcome Measures

Primary Outcomes (4)

  • Describe and evaluate community screening standards and practices.

    1 year

  • Describe and evaluate the relationships of screening venues with care-providing venues.

    1 year

  • Describe and evaluate referral and intake protocols.

    1 year

  • Describe and evaluate care adherence support (including support from both clinical and non-clinical sources).

    1 year

Study Arms (3)

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 Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Childrens Diagnostic&Treatment Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami School of Medicine

Miami, Florida, 33101, United States

Location

Mount Sinai Medical Center

Manhattan, New York, 10128, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • J. Dennis Fortenberry, MD

    Adolescent Trials Network

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 23, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 28, 2017

Record last verified: 2016-02

Locations