HIVNCT00891644
Linkage to Care - Part II
An observational study of HIV and Care-seeking, run by University of North Carolina, Chapel Hill at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- HIV, Care-seeking, HIV Infections
- What is being tested?
- Case Management, Snowball sampling and Referral Lists
- How many people
- 59 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2009to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Childrens Memorial Hospital
Chicago, Illinois, 60614
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital at Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase II
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.
Read the 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.
- Conditions
- HIV, Care-seeking, HIV Infections
- Being tested
- Case Management, Snowball sampling, Referral Lists
- Keywords
- HIV, Care-seeking
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case ManagementOther
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 samplingOther
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 ListsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV positive adolescents who never initiated care within 6 months of receipt of HIV positive results. Receives: Other: Case Management; Other: Snowball sampling | |
| 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. Receives: Other: Referral Lists | |
| 3 | HIV positive adolescents who initiated care and maintained care. These youth are currently in care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospectively recreate the process and timeline of care-seeking among screened HIV positive adolescents.
Measured: 1 year
Secondary outcomes (1)
Evaluate technical aspects of identification and recruitment of HIV positive adolescents who have not engaged in care or who have not maintained care.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Dennis Fortenberry, MD, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891644
- Sponsor's protocol ID
- ATN 066b
- Status last verified
- Feb 2016
- First submitted
- 30 Apr 2009
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase II
- ClinicalTrials.gov ID
- NCT00891644
- Acronym / sponsor ID
- ATN 066b
- Conditions
- HIV, Care-seeking, HIV Infections
- Keywords
- HIV, Care-seeking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Case Management, Other: Snowball samplingHIV positive adolescents who never initiated care within 6 months of receipt of HIV positive results. |
| 2 | – | Other: Referral ListsHIV 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. |
| 3 | – | –HIV positive adolescents who initiated care and maintained care. These youth are currently in care. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case ManagementClinical 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. | Other | 1 |
| Snowball samplingSnowball 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. | Other | 1 |
| Referral ListsAMTU 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. | Other | 2 |
Primary outcome
Retrospectively recreate the process and timeline of care-seeking among screened HIV positive adolescents.
Time frame: 1 year
1 secondary outcome
Evaluate technical aspects of identification and recruitment of HIV positive adolescents who have not engaged in care or who have not maintained care.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- ATN WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Fortenberry, MD study chair
Adolescent Trials Network
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Care-seeking, run by University of North Carolina, Chapel Hill at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospectively recreate the process and timeline of care-seeking among screened HIV positive adolescents. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.