Linkage to Care - Part II

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.

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.)