Intervention Development for Newly Diagnosed Youth With HIV

NCT00255892 | Completed

• 1 other identifier: ATN 055
• Study Type: observational
• Target: 48
• Locations: 2 countries
• Sites: 3

Brief 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. 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.

Conditions

HIV

Keywords

HIV

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  4 Months

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (3)

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

University of Puerto Rico, School of Medicine

San Juan, 00936-5067, Puerto Rico

Location

Related Links

• Website for the Adolescent Trials Network for HIV/AIDS Interventions

Study Officials

• Sybil G. Hosek, PhD

  John Stroger Jr. Hospital of Cook County

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 21, 2005
• Study Start: February 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: February 28, 2017

Record last verified: 2016-02

Locations

US (2); PR (1)