Intervention Development for Newly Diagnosed Youth With HIV

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936-5067
    • University of Puerto Rico, School of Medicine
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stroger Hospital of Cook County
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Sybil G. Hosek, PhD, John Stroger Jr. Hospital of Cook County

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: November 16, 2005
• First Submitted That Met QC Criteria: November 16, 2005
• First Posted (Estimate): November 21, 2005

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: HIV
• Other Study ID Numbers: ATN 055