Clinical trial NCT00103896: Connect to Protect Partnerships for Youth Prevention Interventions: Phase II
Official title: Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: High-risk youth
HIV infected youth
Community mobilization
HIV serosurveys
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-02-16
Enrollment: 16706
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 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
timeFrame: One time assessment at 10 months
measure: Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
timeFrame: One time assessment at 10 months
measure: Describe social networks of adolescents and young adults recruited from targeted venues
timeFrame: One time assessment at 10 months
measure: Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
timeFrame: One time assessment at 10 months
measure: Assess the characteristics of the community-researcher partnerships
timeFrame: One time assessment at 10 months
measure: Assess quality of the community-researcher partnerships
timeFrame: One time assessment at 10 months
measure: Assess outcomes of the community-researcher partnerships
timeFrame: One time assessment at 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: UCSD Mother, Child & Adolescent HIV Program
state: California
city: San Francisco
country: United States
facility: Univ of Califormia at San Francisco
state: California
city: Washington
country: United States
facility: Children's Hospital National Medical Center
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Children's Diag. and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: USF Peds Div. of Infectious Disease
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Childrens' Hospital of Boston
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center, Adolescent AIDS Program
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hopsital of Philadelphia
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Johns Hopkins Medical Center
name: Jonathan Ellen, MD
role: STUDY_CHAIR
affiliation: Division of Adolescent & Young Adult Medicine University of MD, Medical School
name: Ligia Peralta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Donna Futterman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Childrens Hosp of Los Angeles, Division of Adolescent Medicine
name: Marvin Belzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Bret Rudy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Research Institute
name: Larry D'Angelo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Cathryn Samples, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: John H. Stroger Jr. Hospital and the CORE Center
name: Lisa Henry-Reid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL
name: Ana Puga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami, School of Medicine, Div of Adolescent Medicine
name: Lawrence Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida, Peds Div of Infectious Disease
name: Patricia Emmanuel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane Medical Center
name: Sue Ellen Abdalian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Adolescent Health Center
name: Linda Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico Medical Sciences Campus
name: Irma Febo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD Mother, Child, & Adolescent HIV Program
name: Stephen A Spector, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD Mother, Child, & Adolescent HIV Program
name: Rolando M Viani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF, Division of Adoles. Med
name: Barbara Moscicki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF, Division of Adoles. Med
name: Coco Auerswald, MD
role: PRINCIPAL_INVESTIGATOR
References: