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

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Community Mobilization

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00271908

ATN 040b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,472 patients

Sex: All

Ages: 12 to 24 years old

Volunteers: Accepts Healthy Volunteers

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 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.

Trial design

4,472 participants in 2 patient groups

Cohort #1

Description:

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.

Treatment:

Behavioral: Community Mobilization

Cohort #2

Description:

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.

Treatment:

Behavioral: Community Mobilization