Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT00103896
First received: February 15, 2005
Last updated: July 6, 2016
Last verified: July 2016
  Purpose

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.


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II

Resource links provided by NLM:


Further study details as provided by Westat:

Primary Outcome Measures:
  • Ascertain specific community venues where at-risk youth can be recruited for interventions within the high-risk areas identified in the first Phase of the study [ Time Frame: One time assessment at 10 months ] [ Designated as safety issue: No ]
    The outcome measure will be assessed using results from: (a) Phase I mapping; (b) Phase II interviews with HIV-infected youth; and (c) Phase II Brief Venue Interviews (BVIs). Input from community partners and ethnographic procedures will add critical information.

  • Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues [ Time Frame: One time assessment at 10 months ] [ Designated as safety issue: No ]
    The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.

  • Describe social networks of adolescents and young adults recruited from targeted venues [ Time Frame: One time assessment at 10 months ] [ Designated as safety issue: No ]
    The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.

  • Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues [ Time Frame: One time assessment at 10 months ] [ Designated as safety issue: No ]
    The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.

  • Assess the characteristics of the community-researcher partnerships [ Time Frame: One time assessment at 10 months ] [ Designated as safety issue: No ]
    The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.

  • Assess quality of the community-researcher partnerships [ Time Frame: One time assessment at 10 months ] [ Designated as safety issue: No ]
    The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.

  • Assess outcomes of the community-researcher partnerships [ Time Frame: One time assessment at 10 months ] [ Designated as safety issue: No ]
    The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.


Enrollment: 16706
Study Start Date: September 2003
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).
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).
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)..

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.

  Eligibility

Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV infected youth, ages 12 through 24 years old, in treatment/care at each of the 15 ATN sites will be interviewed using ACASI technology to reveal possible venues where youth at high risk for acquiring the HIV may be found. Individuals approached at 3-5 of these identified venues who appear to be 12 through 24 years will be offered a brief venue interview. Anonymous HIV serosurvey (ACASI and HIV-Ab assay) will be administered to 20-30 young women at 2-3 identified high-risk venues, and 20-30 young men at 2-3 identified high-risk venues, who provide verbal confirmation of being 12 through 24 years old, and whose HIV status is unknown to the site staff.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103896

Locations
United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90054
UCSD Mother, Child & Adolescent HIV Program
San Diego, California, United States, 92103
Univ of Califormia at San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Children's Hospital National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Children's Diag. and Treatment Center
Ft. Lauderdale, Florida, United States, 33301
University of Miami
Miami, Florida, United States, 33101
USF Peds Div. of Infectious Disease
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Childrens' Hospital of Boston
Boston, Massachusetts, United States, 02115
United States, New York
Montefiore Medical Center, Adolescent AIDS Program
Bronx, New York, United States, 10467
Mount Sinai Medical Center
New York, New York, United States, 10128
United States, Pennsylvania
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Westat
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Study Chair: Jonathan Ellen, MD Johns Hopkins Medical Center
Principal Investigator: Ligia Peralta, MD Division of Adolescent & Young Adult Medicine University of MD, Medical School
Principal Investigator: Donna Futterman, MD Montefiore Medical Center
Principal Investigator: Marvin Belzer, MD Childrens Hosp of Los Angeles, Division of Adolescent Medicine
Principal Investigator: Bret Rudy, MD Children's Hospital of Philadelphia
Principal Investigator: Larry D'Angelo, MD Children's Research Institute
Principal Investigator: Cathryn Samples, MD Boston Children’s Hospital
Principal Investigator: Lisa Henry-Reid, MD John H. Stroger Jr. Hospital and the CORE Center
Principal Investigator: Ana Puga, MD Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL
Principal Investigator: Lawrence Friedman, MD University of Miami, School of Medicine, Div of Adolescent Medicine
Principal Investigator: Patricia Emmanuel, MD University of South Florida, Peds Div of Infectious Disease
Principal Investigator: Sue Ellen Abdalian, MD Tulane Medical Center
Principal Investigator: Linda Levin, MD Mount Sinai Adolescent Health Center
Principal Investigator: Irma Febo, MD University of Puerto Rico, Medical Sciences Campus
Principal Investigator: Stephen A Spector, MD UCSD Mother, Child, & Adolescent HIV Program
Principal Investigator: Rolando M Viani, MD UCSD Mother, Child, & Adolescent HIV Program
Principal Investigator: Barbara Moscicki, MD UCSF, Division of Adoles. Med
Principal Investigator: Coco Auerswald, MD UCSF, Division of Adoles. Med
  More Information

Additional Information:
Responsible Party: Westat
ClinicalTrials.gov Identifier: NCT00103896     History of Changes
Other Study ID Numbers: ATN 016b 
Study First Received: February 15, 2005
Last Updated: July 6, 2016
Health Authority: United States: Federal Government

Keywords provided by Westat:
High-risk youth
HIV infected youth
Community mobilization
HIV serosurveys

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 23, 2016