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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Community Mobilization

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.

• Study Type: Observational
• Enrollment (Actual): 4472

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • University Pediatric Hospital
• United States
  • California
    • Los Angeles, California, United States, 90054
      • Childrens Hospital of Los Angeles
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Childrens Hospital National Medical Center
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stroger Hospital of Cook County
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • New York
    • New York, New York, United States, 10128
      • Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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 Names: No other names
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.	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 Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Jonathan Ellen, MD, Johns Hopkins University

Publications and helpful links

Helpful Links

• Website for the Adolescent Trials Network for HIV/AIDS Interventions

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 30, 2005
• First Submitted That Met QC Criteria: December 30, 2005
• First Posted (Estimate): January 4, 2006

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Adolescent; HIV Seronegativity; HIV; AIDS; Community; Structural Changes
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ATN 040b