Clinical trial NCT00891644: Linkage to Care - Part II
Official title: HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Care-seeking
HIV Infections
Keywords: HIV
Care-seeking
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: 2009-05-01
Enrollment: 59
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Behaviorally-infected, HIV positive adolescents, informed of their HIV diagnosis within 6-18 months of the protocol screening date, who provide consent for study participation;
2. Ages 14-24 years, inclusive at the time of protocol screening;
3. Males and females; and
4. English- or Spanish-speaking

Group 1 - HIV positive adolescents who never initiated care within 6 months of receipt of HIV positive results; Group 2 - HIV positive adolescents who initiated care, but did not follow up with care within 12 months of the initial care visit. Also included in this group are those who initiated and followed-up with care, but have dropped out of care for 12 or more months; and Group 3 - HIV positive adolescents who initiated care and maintained care. These youth are currently in care.

Brief summary: This is the second phase of a two-phase, cross-sectional study of linkage to medical care of HIV positive youth. Social, psychological and behavioral factors associated with receipt of care will be evaluated. This study will also compare three methods for recruitment of out-of-care youth using a randomized permuted block list of possible sequences.

Detailed description: ATN 066b consists of a cross-sectional evaluation of three groups of recently diagnosed HIV-infected adolescents including: (1) care non-initiation; (2) care initiation, no maintenance; and (3) care initiation with maintenance. Social, psychological and behavioral factors associated with HIV-related care-seeking will be assessed using an ACASI. Three recruitment strategies using a randomized permuted block list of possible sequences for HIV-infected youth not in care will be also compared.

The ACASI instrument will be adapted from previously used instruments intended to retrospectively reconstruct the care-seeking process and to assess quality of life, concerns and expectations for care, satisfaction with care, and social-problem solving.

Ideally, the ACASI will be administered during a single session and may take up to 90 minutes to complete. Participants who are unable to complete the ACASI in one session will be allowed up to 7 days after initiation to complete it. Completion of all study data collection, including accrual period, is expected to take approximately 12 months. Outcome measures will be classified as (1) care non-initiation; (2) care initiation, no maintenance; or (3) care initiation and maintenance.

The assessment of recruitment strategies most effective for not in care youth will include: use of usual case-management approaches; snowball sampling and venue-based advertisement.

Eligibility criteria: Inclusion Criteria:

* HIV-1 infection behaviorally-acquired at age 10 years or older, by the site staff's best determination;
* HIV-1 infection documented by a positive result on any of the following licensed tests at any time: any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR \> 1,000 copies/ml; NOTE: Anonymous HIV-1 antibody test results, with confirmation by Western blot, will be considered an acceptable form of documentation for those individuals who do not wish to have their name linked to their HIV diagnosis. The original slip containing the result will need to be presented. If individuals request that their test results remain anonymous, AMTUs are encouraged to retest using an anonymous method.
* Documented or self-reported receipt of HIV positive diagnosis between 6 -18 months, inclusive, prior to the protocol screening date; NOTE: The protocol team will monitor enrollment during the first 3 months of study implementation and may expand this window to 24 months, if necessary.
* Ages 14 - 24 years, inclusive at the time of protocol screening;
* Ability to understand and willingness to provide written informed consent/assent in English or Spanish;
* Group 1: Never initiated HIV-related medical care and 6 or more months have elapsed since receipt of an HIV diagnosis. This cohort is not currently considered in care;
* Group 2: Initiated HIV-related medical care, but 12 or more months have elapsed since care was initiated, and has not had additional HIV-related medical care since the initial visit; or
* Group 2: Initiated and had follow up HIV-related medical care, but is no longer in care for 12 or more months since the last visit. This cohort is not currently considered in care; and
* Group 3: Initiated and maintained HIV-related medical care with at least one maintenance visit within the 12 months prior to the protocol screening date. This cohort is currently considered in care.

Exclusion Criteria:

* Psychiatric disorder (untreated) associated with thought disorder, hallucinations, acute substance use withdrawal. Stabilized patients receiving appropriate psychiatric care will not be excluded if informed consent can be reasonably assumed;
* Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood; exhibiting manic, suicidal, or violent behavior);
* Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with ability to give true informed consent and to adhere to the study requirements;
* Known pregnancy;
* Acute illness that, in the opinion of the treating clinician, would endanger the well-being of the individual if treatment was delayed due to study participation;
* HIV positive adolescents infected through either perinatal transmission or blood products, including those who became aware of their HIV diagnosis within the prior 6 -18 months; and
* Explicit prior refusal of permission by the adolescent for any subsequent contact by site personnel. (Adolescents who wish to participate and provide signed informed consent, but who cannot or will not provide contact information, do not meet this exclusion criterion.)

Primary outcomes:
measure: Retrospectively recreate the process and timeline of care-seeking among screened HIV positive adolescents.
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate technical aspects of identification and recruitment of HIV positive adolescents who have not engaged in care or who have not maintained care.
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hopsital of Los Angeles
state: California
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
city: Bronx
country: United States
facility: Children's Hospital at Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hopsital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Adolescent Trials Network
name: Dennis Fortenberry, MD
role: STUDY_CHAIR
References: