C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions
Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation
1 other identifier
observational
4,472
2 countries
8
Brief Summary
During Phase III, Adolescent Trials Network for HIV/AIDS Interventions (ATN)/Connect-to-Protect (C2P) site staff, their official community partners established in Phase I, and newly invited community sector representatives (i.e., individuals from various key parts of the community such as family, spiritual or faith-based institutions, business and government) will form a coalition that will work toward achieving C2P objectives. ATN 040b is the evaluation protocol for ATN 040, Phase III of C2P.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2007
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2005
CompletedFirst Posted
Study publicly available on registry
January 4, 2006
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFebruary 28, 2017
March 1, 2016
3.5 years
December 30, 2005
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention
The aim of ATN 040b is to collect data that will be used to evaluate the overall efficacy of the community mobilization intervention and to assess changes in HIV-related risks over time.
4 years
Study Arms (2)
Cohort #1
Venue-tracking survey subjects recruited annually for 4 years: N= 320-640 (10-20 members of the population of focus per site, per year). The purpose of this cohort is to identify and track venues at which the population of focus congregates.
Cohort #2
HIV-related risk survey subjects recruited annually for 4 years: N = 1280-2880 (20-30 members of the population of focus per 2-3 congregation venues, per site, per year). These subjects will complete a survey designed to assess HIV-related risk. In the fourth and final year only, HIV Antibody \[Ab\] assays will also be conducted with survey participants to assess HIV serostatus. The survey and HIVAb assay data will be used to evaluate the intervention within and across sites.
Interventions
ATN 040b is the evaluation sub-study for ATN 040, Phase III of C2P. Phase III is a community mobilization intervention aimed at reducing HIV rates among youth via community structural change. ATN 040b involves annual anonymous data collection with two cohorts per participating ATN/C2P site. Both cohorts will represent the site's target population, or "population of focus."
Eligibility Criteria
Each site's population of focus was determined during C2P's Phase I (ATN 016a) and is one of the following: young women who have sex with men (YWSM), young men who have sex with men (YMSM), or young users of drugs. For each population, the age range must fall between 12 and 24 years, inclusive.
You may qualify if:
- An individual who provides verbal confirmation that his or her age falls within the range of the site's population of focus (which must be within 12 through 24 years, inclusive);
- Verbal confirmation of demographic and sexual orientation/experience profile reflective of the site's population of focus;
- Must report engaging in any voluntary sexual activity (vaginal, anal or oral sex) within the past 12 months, regardless of sexual abuse history; and
- Ability to understand and willingness to provide verbal informed consent/assent in English or Spanish.
You may not qualify if:
- Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood; exhibiting manic, suicidal, or violent behavior);\*
- Visibly intoxicated or under the influence of psychoactive agents#; or
- Presents as acutely ill.
- For sites targeting drug users, this may pose challenges. Potential participants who are visibly under the influence are to be further assessed in terms of their level of alertness, coherency, and abilities to understand and respond to questions. This is to be done keeping staff and participant safety in mind, as well as follow-up procedures such as providing service referrals.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Childrens Hospital of Los Angeles
Los Angeles, California, 90054, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Childrens Hospital National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of South Florida
Tampa, Florida, 33606, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Mount Sinai Medical Center
New York, New York, 10128, United States
University Pediatric Hospital
San Juan, 00936, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jonathan Ellen, MD
Johns Hopkins University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2005
First Posted
January 4, 2006
Study Start
February 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
February 28, 2017
Record last verified: 2016-03