Linkage to Care - Part II

HIV Infections Clinical Trial

Official title:

HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891644
• Other study ID #: ATN 066b
• Status: Completed
• Phase: N/A
• First received: April 30, 2009
• Last updated: February 27, 2017
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Care-seeking
• HIV
• HIV Infections

Intervention

Other:
• Case Management
Clinical personnel at each AMTU site may work with other personnel from organizations authorized to have access to personal health information to identify clients identified as HIV positive within the past 6 - 18 months. Initial contact will be made by persons at source organizations who are authorized to have access to personal health information. Persons so authorized will explain the nature of the research study and request permission from the client for subsequent contact by research personnel from the AMTU site. If permission for contact is received, research personnel at each site will attempt calls as specified by the potential participant or at random times (before 12:00 pm; between 12:00 - 4:00 pm; and between 4:00 - 10:00 pm) for no more than 10 attempts.
• Snowball sampling
Snowball sampling assumes that social networks of HIV sero-positive persons in treatment may overlap with those of HIV sero-positive persons not in treatment. When a site is assigned to identify HIV positive adolescents not in care by snowball sampling, all HIV positive persons in care at the site will be invited to refer other adolescents known to them as HIV positive, but not in care, for possible participation in the study. Printed information containing a brief description of the research in English and in Spanish and contact information of site study personnel will be provided to in-care adolescents at the site for distribution to those known HIV positive adolescents who are not in care.
• Referral Lists
AMTU staff will develop lists of potential participants at their sites who have had an initial HIV-related health care visit but not received additional visits within the 12 mos prior the list (or before protocol screening) or have completed initial and follow up visits but dropped out of care for 12 or more mos. Back-up lists will be made of potential participants who have gone 9-12 mos and 6-9 mos without a visit. Clinical staff at each AMTU may work with staff from other organizations authorized to access personal health information to find potential participants. 1st contact will be made by persons at source organizations who are authorized to access personal health information. Authorized staff will explain the study and ask permission for contact by research staff at the AMTU site. If so, research staff will attempt calls as specified by the potential participant or at random (before 12 pm; between 12-4 pm; and between 4-10 pm) for no more than 10 attempts.

Locations

Country	Name	City	State
United States	Children's Hospital at Montefiore Medical Center	Bronx	New York
United States	Childrens Memorial Hospital	Chicago	Illinois
United States	Children's Diagnostic and Treatment Center	Fort Lauderdale	Florida
United States	Children's Hopsital of Los Angeles	Los Angeles	California
United States	Children's Hopsital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospectively recreate the process and timeline of care-seeking among screened HIV positive adolescents.		1 year
Secondary	Evaluate technical aspects of identification and recruitment of HIV positive adolescents who have not engaged in care or who have not maintained care.		1 year

External Links

•   ATN Website