Intervention Development for Newly Diagnosed Youth With HIV

NCT ID: NCT00255892

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sybil G. Hosek, PhD

Role: STUDY_CHAIR

John Stroger Jr. Hospital of Cook County

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status

Montefiore Medical Center

New York, New York, United States

Site Status

University of Puerto Rico, School of Medicine

San Juan, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Related Links

Access external resources that provide additional context or updates about the study.

http://www.atnonline.org

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATN 055

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Linkage to Care - Part II
NCT00891644 COMPLETED
Linkage to Care - Part I
NCT00703040 COMPLETED
Confidential Care and Adolescent HIV Testing
NCT06279949 NOT_YET_RECRUITING NA