Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection

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.

• Study Type: Observational
• Enrollment (Actual): 16706

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • University Pediatric Hospital
• United States
  • California
    • Los Angeles, California, United States, 90054
      • Childrens Hospital of Los Angeles
    • San Diego, California, United States, 92103
      • UCSD Mother, Child & Adolescent HIV Program
    • San Francisco, California, United States, 94143
      • Univ of Califormia at San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's Hospital National Medical Center
  • Florida
    • Ft. Lauderdale, Florida, United States, 33301
      • Children's Diag. and Treatment Center
    • Miami, Florida, United States, 33101
      • University of Miami
    • Tampa, Florida, United States, 33606
      • USF Peds Div. of Infectious Disease
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stroger Hospital of Cook County
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Childrens' Hospital of Boston
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center, Adolescent AIDS Program
    • New York, New York, United States, 10128
      • Mount Sinai Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hopsital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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)..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	One time assessment at 10 months
Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues	The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.	One time assessment at 10 months
Describe social networks of adolescents and young adults recruited from targeted venues	The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.	One time assessment at 10 months
Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues	The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.	One time assessment at 10 months
Assess the characteristics of the community-researcher partnerships	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.	One time assessment at 10 months
Assess quality of the community-researcher partnerships	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.	One time assessment at 10 months
Assess outcomes of the community-researcher partnerships	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.	One time assessment at 10 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: Principal Investigator: Donna Futterman, MD, Montefiore Medical Center; Principal Investigator: Sue Ellen Abdalian, MD, Tulane Medical Center; 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: 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 National 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: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: February 15, 2005
• First Submitted That Met QC Criteria: February 15, 2005
• First Posted (Estimate): February 16, 2005

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Community mobilization; High-risk youth; HIV infected youth; HIV serosurveys
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ATN 016b