Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

Tracking Information
First Submitted Date	February 15, 2005
First Posted Date	February 16, 2005
Last Update Posted Date	March 1, 2017
Study Start Date	September 2003
Actual Primary Completion Date	October 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: July 6, 2016)	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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00103896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Connect to Protect Partnerships for Youth Prevention Interventions: Phase II
Official Title	Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II
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.
Study Type	Observational
Study Design	Observational Model: Ecologic or Community; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition	HIV Infection
Intervention	Not Provided
Study 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)..
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: July 6, 2016)	16706
Original Enrollment	Not Provided
Actual Study Completion Date	October 2010
Actual Primary Completion Date	October 2010 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: All
Ages	12 Years to 24 Years (Child, Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Puerto Rico, United States
Removed Location Countries
Administrative Information
NCT Number	NCT00103896
Other Study ID Numbers	ATN 016b
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of North Carolina, Chapel Hill
Study Sponsor	University of North Carolina, Chapel Hill
Collaborators	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
PRS Account	University of North Carolina, Chapel Hill
Verification Date	July 2016