Clinical trial NCT00703040: Linkage to Care - Part I
Official title: HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Care engagement
Linkage to care
HIV Infections
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2008-06-23
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Describe and evaluate community screening standards and practices.
timeFrame: 1 year
measure: Describe and evaluate the relationships of screening venues with care-providing venues.
timeFrame: 1 year
measure: Describe and evaluate referral and intake protocols.
timeFrame: 1 year
measure: Describe and evaluate care adherence support (including support from both clinical and non-clinical sources).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Childrens Diagnostic&Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhattan
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
Study officials:
affiliation: Adolescent Trials Network
name: J. Dennis Fortenberry, MD
role: STUDY_CHAIR
References: