Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

NCT ID: NCT00103896

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16706 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2010-10-31

Brief Summary

This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities.

This phase will describe specific locations within high-risk areas where youth, ages 12-24, spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at these venues will be assessed by administering anonymous computerized interviews to eligible and willing youth. This information will be shared with community partners during scheduled working group meetings.

Detailed Description

This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such ATN research activities.

During this phase, each ATN site will gather additional information within high-risk areas and solicit community partner input to ultimately pinpoint the specific locations where at-risk youths, ages 12-24, may be recruited for interventions. This will be done by the following methods:

Venues will be identified by HIV+ youth at the ATN site by participation in an anonymous computerized interview. Site staff will then perform brief venue interviews (BVIs) at selected venues to assess the potential yield of youths 12-24 years old. Community partners will also provide the site staff with information on known high-risk venues. High-risk venues will further be identified by the results of anonymous computerized interviews and HIV assays obtained from eligible and willing youth participants at the venues. The interviews will gather information on HIV risk behaviors, social networking patterns and HIV prevalence among youths at these venues. This information will be shared with community partners during scheduled working group meetings.

Conditions

HIV Infection

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV Infected Youth in Treatment/Care

HIV infected youth in treatment/care will be interviewed using Audio Computer-Assisted Self-Administered Interview ACASI technology to reveal possible venues where youth at high risk for acquiring the disease may be found (N = 20-30 individuals per ATN site).

No interventions assigned to this group

BVI Individuals

Additional data will be gathered on potential recruitment venues by administering a brief venue interview (BVI) to individuals who appear to be between 12 and 24 years old (N = unlimited individuals during 3-5 assessment periods per venue each lasting 5 hours).

No interventions assigned to this group

HIV Serosurvey Individuals

HIV Serosurvey Individuals Anonymous structured interview using ACASI technology and an anonymous HIV antibody assay will be administered to 20-30 young women at 2-3 targeted locations and 20-30 young men at 2-3 targeted locations whose HIV status is unknown (N = 160-360 individuals per ATN site)..

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Index Subjects:

• Documented HIV-infection
• Acquisition of HIV after age 9 years
• Verbal confirmation of 12-24 years of age
• Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
• Ability to understand and willingness to provide informed consent/assent

BVI subjects:

• Youths who appear to be 12-24 years old

HIV Serosurvey subjects at the venues:

• Verbal confirmation of 12-24 years of age
• Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
• Ability to understand and willingness to provide informed consent/assent

Exclusion Criteria

• Visibly distraught and/or emotionally unstable (i.e. depressive mood, exhibiting manic, suicidal or violent behavior, etc.)
• Visibly intoxicated or under the influence of psychoactive agents
• Clinically presents as acutely ill

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Ellen, MD

Role: STUDY_CHAIR

Johns Hopkins Medical Center

Ligia Peralta, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Adolescent & Young Adult Medicine University of MD, Medical School

Donna Futterman, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Marvin Belzer, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Hosp of Los Angeles, Division of Adolescent Medicine

Bret Rudy, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Larry D'Angelo, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Cathryn Samples, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Lisa Henry-Reid, MD

Role: PRINCIPAL_INVESTIGATOR

John H. Stroger Jr. Hospital and the CORE Center

Ana Puga, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL

Lawrence Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami, School of Medicine, Div of Adolescent Medicine

Patricia Emmanuel, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida, Peds Div of Infectious Disease

Sue Ellen Abdalian, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane Medical Center

Linda Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Adolescent Health Center

Irma Febo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Puerto Rico Medical Sciences Campus

Stephen A Spector, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Mother, Child, & Adolescent HIV Program

Rolando M Viani, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Mother, Child, & Adolescent HIV Program

Barbara Moscicki, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF, Division of Adoles. Med

Coco Auerswald, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF, Division of Adoles. Med

Locations

Childrens Hospital of Los Angeles

Los Angeles, California, United States

UCSD Mother, Child & Adolescent HIV Program

San Diego, California, United States

Univ of Califormia at San Francisco

San Francisco, California, United States

Children's Hospital National Medical Center

Washington D.C., District of Columbia, United States

Children's Diag. and Treatment Center

Fort Lauderdale, Florida, United States

University of Miami

Miami, Florida, United States

USF Peds Div. of Infectious Disease

Tampa, Florida, United States

Stroger Hospital of Cook County

Chicago, Illinois, United States

Tulane Medical Center

New Orleans, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Childrens' Hospital of Boston

Boston, Massachusetts, United States

Mount Sinai Medical Center

New York, New York, United States

Montefiore Medical Center, Adolescent AIDS Program

The Bronx, New York, United States

Children's Hopsital of Philadelphia

Philadelphia, Pennsylvania, United States

University Pediatric Hospital

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Related Links

http://www.atnonline.org

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Other Identifiers

ATN 016b

Identifier Type: -

Identifier Source: org_study_id