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C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions

Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00271908
Enrollment
4472
Registered
2006-01-04
Start date
2007-02-28
Completion date
2010-08-31
Last updated
2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, AIDS, Adolescent, Community, Structural Changes, HIV Seronegativity

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.

Detailed description

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.

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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
National Institute of Mental Health (NIMH)
CollaboratorNIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
Yes

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 * Presents as acutely ill. * Although it is very unlikely that an individual from the community will overtly show signs of suicidality, youth with any of these

Design outcomes

Primary

MeasureTime frameDescription
Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention4 yearsThe 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.

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026