Intervention Development for Newly Diagnosed Youth With HIV
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ClinicalTrials.gov Identifier: NCT00255892 |
Recruitment Status
:
Completed
First Posted
: November 21, 2005
Last Update Posted
: February 28, 2017
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Condition or disease |
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HIV |
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 Type : | Observational |
Actual Enrollment : | 48 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Intervention Development for Newly Diagnosed Youth With HIV |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2007 |

Group/Cohort |
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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.
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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. |
- 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.

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Ages Eligible for Study: | 16 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255892
United States, Illinois | |
Stroger Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
United States, New York | |
Montefiore Medical Center | |
New York, New York, United States, 10467 | |
Puerto Rico | |
University of Puerto Rico, School of Medicine | |
San Juan, Puerto Rico, 00936-5067 |
Study Chair: | Sybil G. Hosek, PhD | John Stroger Jr. Hospital of Cook County |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00255892 History of Changes |
Other Study ID Numbers: |
ATN 055 |
First Posted: | November 21, 2005 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | February 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
HIV |