Intervention Development for Newly Diagnosed Youth With HIV

HIV Clinical Trial

Official title:

Intervention Development for Newly Diagnosed Youth With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255892
• Other study ID #: ATN 055
• Status: Completed
• Phase: N/A
• First received: November 16, 2005
• Last updated: February 27, 2017
• Start date: February 2006
• Est. completion date: March 2007

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico, School of Medicine	San Juan
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Montefiore Medical Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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