C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions
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| ClinicalTrials.gov Identifier: NCT00271908 |
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Recruitment Status
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Completed
First Posted
: January 4, 2006
Last Update Posted
: February 28, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| HIV Infections | Behavioral: Community Mobilization |
Phase III's objective is to initiate and complete a community mobilization intervention aimed at reducing HIV incidence and prevalence among youth. The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. The effectiveness of the intervention will be evaluated by tracking venues where the population of interest congregates and trends in risk factors associated with HIV acquisition and transmission.
ATN 040b evaluates annual anonymous data collection of two cohorts per participating ATN/C2P site. Both cohorts will represent a site's population of focus, but will be recruited in different ways and for different activities.
Cohort #1 will be referred to the site via Official Community Partners and word of mouth. Each year of the study, 10 to 20 individuals will be recruited to complete venue-tracking surveys as described in Section 2.1 (N = 40-80 per site over four years). The results will either confirm that the population of focus can still be reached at previously identified congregation venues or reveal new ones that should be considered for further research activities. Each year, based on data from Cohort #1, ATN/C2P site staff will go to two to three of the confirmed and/or new congregation venues to recruit 20 to 30 participants per venue for Cohort #2. These participants will complete the HIV-related risk survey, with the addition of the HIV-Ab assay in the final year only (N = 160-360 per site over four years). Data will be used to evaluate the intervention within and across ATN/C2P sites.
| Study Type : | Observational |
| Actual Enrollment : | 4472 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation |
| Study Start Date : | February 2007 |
| Actual Primary Completion Date : | August 2010 |
| Actual Study Completion Date : | August 2010 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Behavioral: Community Mobilization
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."
Other Name: No other names
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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.
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Behavioral: Community Mobilization
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."
Other Name: No other names
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- Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention [ Time Frame: 4 years ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years to 24 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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Presents as acutely ill.
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Although it is very unlikely that an individual from the community will overtly show signs of suicidality, youth with any of these exclusion criteria may be approached at a later date if encountered again at the venue and earlier exclusionary conditions are resolved.
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271908
| United States, California | |
| Childrens Hospital of Los Angeles | |
| Los Angeles, California, United States, 90054 | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, District of Columbia | |
| Childrens Hospital National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| Stroger Hospital of Cook County | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10128 | |
| Puerto Rico | |
| University Pediatric Hospital | |
| San Juan, Puerto Rico, 00936 | |
| Study Chair: | Jonathan Ellen, MD | Johns Hopkins University |
Additional Information:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00271908 History of Changes |
| Other Study ID Numbers: |
ATN 040b |
| First Posted: | January 4, 2006 Key Record Dates |
| Last Update Posted: | February 28, 2017 |
| Last Verified: | March 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
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HIV AIDS Adolescent |
Community Structural Changes HIV Seronegativity |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |