Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

NCT00103896 | Completed

• 1 other identifier: ATN 016b
• Study Type: observational
• Target: 16,706
• Locations: 2 countries
• Sites: 15

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.

Conditions

HIV Infection

Keywords

High-risk youth; HIV infected youth; Community mobilization; HIV serosurveys

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

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)..

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (15)

Childrens Hospital of Los Angeles

Los Angeles, California, 90054, United States

Location

UCSD Mother, Child & Adolescent HIV Program

San Diego, California, 92103, United States

Location

Univ of Califormia at San Francisco

San Francisco, California, 94143, United States

Location

Children's Hospital National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Diag. and Treatment Center

Fort Lauderdale, Florida, 33301, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

USF Peds Div. of Infectious Disease

Tampa, Florida, 33606, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Childrens' Hospital of Boston

Boston, Massachusetts, 02115, United States

Location

Mount Sinai Medical Center

New York, New York, 10128, United States

Location

Montefiore Medical Center, Adolescent AIDS Program

The Bronx, New York, 10467, United States

Location

Children's Hopsital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University Pediatric Hospital

San Juan, 00936, Puerto Rico

Location

Related Links

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

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jonathan Ellen, MD

  Johns Hopkins Medical Center

  STUDY CHAIR

• 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 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

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2005
• First Posted: February 16, 2005
• Study Start: September 1, 2003
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 1, 2017

Record last verified: 2016-07

Locations

PR (1); US (14)