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

February 15, 2005
July 6, 2016
September 2003
October 2010   (final data collection date for primary outcome 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 [ 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.
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Complete list of historical versions of study NCT00103896 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
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Non-Probability Sample
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.
HIV Infection
Not Provided
  • 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)..
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16706
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 24 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00103896
ATN 016b
No
Not Provided
Not Provided
Westat
Westat
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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
Westat
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP