HIVNCT00255892
Intervention Development for Newly Diagnosed Youth With HIV
An observational study of HIV, run by University of North Carolina, Chapel Hill at 3 sites in 2 countries.
Trial summary
This study is an exploratory qualitative investigation of the challenges, strengths, and needed areas of support associated with receiving an HIV diagnosis among youth living with HIV. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- HIV
- How many people
- 48 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2006to Mar 2007
- 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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with HIV+ youth; a target number of one from each category will be interviewed from all 15 ATN sites. The focus groups will be comprised of participants who are between the ages of 16 and 24, diagnosed HIV+ and aware of their HIV diagnosis for between 12-24 months, and receive services at one of the three selected ATN sites or their community partner. Focus group participants will be balanced to reflect the diversity (i.e., age, pregnant and parenting women, men who have sex with men (MSM), mono-lingual Spanish-speaking, etc.) of the clinic populations.
Who may be able to join
- Diagnosed HIV+ and aware of their HIV status for between 12-24 months
- Between the ages of 16-24 (inclusive)
- Gives informed consent for participation
Who cannot join
- Presence of serious psychiatric symptoms (active hallucinations, thought disorder)
- Visibly distraught (suicidal, homicidal, exhibiting violent behavior)
- Intoxicated or under the influence of alcohol or other substances at the time of study entry
- Acquired HIV through perinatal infection
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Montefiore Medical Center
New York, New York, 10467
Puerto Rico1 site
University of Puerto Rico, School of Medicine
San Juan, 00936-5067
About this study
This study is an exploratory qualitative investigation of the challenges, strengths, and needed areas of support associated with receiving an HIV diagnosis among youth living with HIV. Qualitative interviews will be conducted with health care providers who work with adolescents living with HIV and focus groups will be conducted with adolescents who are living with HIV (ages 16-24). One third of the focus groups will be conducted in Spanish. Findings from this study will be used to create an outline and development plan for a culturally-sensitive and developmentally appropriate intervention (or set of interventions) for youth recently diagnosed with HIV.
Read the detailed description
Providers will participate in one interview of approximately one-hour duration; these interviews are expected to occur over a 2 month period. Following the completion of the provider interviews, participants will participate in one 2-hour focus group. A total of 6 focus groups (2 at each of the 3 study sites) are anticipated to occur over a 6-8 week period. The complete study duration is expected to take 12 months.
Part A - Provider interviews - 15 clinical providers, 15 mental health providers, 15 case managers (1 provider from each category per ATN site resulting in a total of 45 interviews).
Part B - Focus groups - 36-48 youth living with HIV. It is estimated there will be 6-8 participants per group and we will conduct two groups at each of three different sites (one male specific group and one female specific group) for a total of six focus groups. One third of the focus groups will be conducted in Spanish.
The provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with HIV+ youth; one from each category will be interviewed from all 15 ATN sites.
The focus groups will be comprised of participants who are between the ages of 16 and 24, diagnosed HIV+ and aware of their HIV diagnosis for between 12-24 months, and receive services at three selected ATN sites or their community partner.
Focus group participants will be balanced to reflect the diversity (i.e., age, pregnant and parenting women, MSM, mono-lingual Spanish-speaking, etc.) of the clinic populations.
- Conditions
- HIV
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Provider Interviews | The provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with HIV-positive youth; one from each category from all 15 ATN sites will be targeted for a total of 45 participants. | |
| Part B - Youth Focus Groups | The focus groups will be comprised of 6-8 participants per group who are between the ages of 16 and 24, diagnosed HIV+ and aware of their HIV diagnosis for between 12-24 months, and receive services at three selected ATN sites or their community partners for a total of 36-48 participants. For the purposes of this study, youth who acquired HIV perinatally will be excluded from participation in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elicit information from HIV+ youth and their healthcare providers in order to guide the development of a psychosocial intervention
To elicit information from HIV+ youth and their healthcare providers in order to guide the development of a psychosocial intervention aimed at improving adjustment to HIV diagnosis among adolescents and young adults recently diagnosed with HIV
Measured: 4 Months
Develop an outline and development plan for a culturally-sensitive and developmentally appropriate intervention
To develop an outline and development plan for a culturally-sensitive and developmentally appropriate intervention (or set of interventions) to improve psychosocial adjustment to an HIV diagnosis among adolescent and young adults recently diagnosed with HIV based on the information collected that is described in Objective 1.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startFeb 2006
- Primary completionMar 2007
- Study completionMar 2007
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.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 48 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), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sybil G. Hosek, PhD, Study chair, John Stroger Jr. Hospital of Cook County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255892
- Sponsor's protocol ID
- ATN 055
- Status last verified
- Feb 2016
- First submitted
- 16 Nov 2005
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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
- Intervention Development for Newly Diagnosed Youth With HIV
- ClinicalTrials.gov ID
- NCT00255892
- Acronym / sponsor ID
- ATN 055
- Conditions
- HIV
- Keywords
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 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), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Nov 2005 (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 study is an exploratory qualitative investigation of the challenges, strengths, and needed areas of support associated with receiving an HIV diagnosis among youth living with HIV. Qualitative interviews will be conducted with health care providers who work with adolescents living with HIV and focus groups will be conducted with adolescents who are living with HIV (ages 16-24). One third of the focus groups will be conducted in Spanish. Findings from this study will be used to create an outline and development plan for a culturally-sensitive and developmentally appropriate intervention (or set of interventions) for youth recently diagnosed with HIV.
Detailed description
Providers will participate in one interview of approximately one-hour duration; these interviews are expected to occur over a 2 month period. Following the completion of the provider interviews, participants will participate in one 2-hour focus group. A total of 6 focus groups (2 at each of the 3 study sites) are anticipated to occur over a 6-8 week period. The complete study duration is expected to take 12 months.
Part A - Provider interviews - 15 clinical providers, 15 mental health providers, 15 case managers (1 provider from each category per ATN site resulting in a total of 45 interviews).
Part B - Focus groups - 36-48 youth living with HIV. It is estimated there will be 6-8 participants per group and we will conduct two groups at each of three different sites (one male specific group and one female specific group) for a total of six focus groups. One third of the focus groups will be conducted in Spanish.
The provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with HIV+ youth; one from each category will be interviewed from all 15 ATN sites.
The focus groups will be comprised of participants who are between the ages of 16 and 24, diagnosed HIV+ and aware of their HIV diagnosis for between 12-24 months, and receive services at three selected ATN sites or their community partner.
Focus group participants will be balanced to reflect the diversity (i.e., age, pregnant and parenting women, MSM, mono-lingual Spanish-speaking, etc.) of the clinic populations.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - Provider Interviews | – | –The provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with HIV-positive youth; one from each category from all 15 ATN sites will be targeted for a total of 45 participants. |
| Part B - Youth Focus Groups | – | –The focus groups will be comprised of 6-8 participants per group who are between the ages of 16 and 24, diagnosed HIV+ and aware of their HIV diagnosis for between 12-24 months, and receive services at three selected ATN sites or their community partners for a total of 36-48 participants. For the purposes of this study, youth who acquired HIV perinatally will be excluded from participation in this study. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with HIV+ youth; a target number of one from each category will be interviewed from all 15 ATN sites. The focus groups will be comprised of participants who are between the ages of 16 and 24, diagnosed HIV+ and aware of their HIV diagnosis for between 12-24 months, and receive services at one of the three selected ATN sites or their community partner. Focus group participants will be balanced to reflect the diversity (i.e., age, pregnant and parenting women, men who have sex with men (MSM), mono-lingual Spanish-speaking, etc.) of the clinic populations.
Key inclusion criteria (3 listed)
- Diagnosed HIV+ and aware of their HIV status for between 12-24 months
- Between the ages of 16-24 (inclusive)
- Gives informed consent for participation
Key exclusion criteria (4 listed)
- Presence of serious psychiatric symptoms (active hallucinations, thought disorder)
- Visibly distraught (suicidal, homicidal, exhibiting violent behavior)
- Intoxicated or under the influence of alcohol or other substances at the time of study entry
- Acquired HIV through perinatal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elicit information from HIV+ youth and their healthcare providers in order to guide the development of a psychosocial intervention
Time frame: 4 Months
To elicit information from HIV+ youth and their healthcare providers in order to guide the development of a psychosocial intervention aimed at improving adjustment to HIV diagnosis among adolescents and young adults recently diagnosed with HIV
Develop an outline and development plan for a culturally-sensitive and developmentally appropriate intervention
Time frame: 4 Months
To develop an outline and development plan for a culturally-sensitive and developmentally appropriate intervention (or set of interventions) to improve psychosocial adjustment to an HIV diagnosis among adolescent and young adults recently diagnosed with HIV based on the information collected that is described in Objective 1.
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.
- Website for the Adolescent Trials Network for HIV/AIDS InterventionsLink 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.
Sybil G. Hosek, PhD study chair
John Stroger Jr. Hospital of Cook County
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of North Carolina, Chapel Hill at 3 sites in 2 countries.
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 3 inclusion and 4 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 3 sites in United States, Puerto Rico. 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?
Elicit information from HIV+ youth and their healthcare providers in order to guide the development of a psychosocial intervention (time frame: 4 Months). The study lists 2 primary outcomes in all. 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.