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Intervention Development for Newly Diagnosed Youth With HIV

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

HIV

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00255892
ATN 055

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

16 to 24 years old

Volunteers

No Healthy Volunteers

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

Trial design

48 participants in 2 patient groups

Part A - Provider Interviews
Description:
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
Description:
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.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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