HIV InfectionsNCT00271908
C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Community Mobilization
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,472 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Feb 2007to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
University of Maryland
Baltimore, Maryland, 21201
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Childrens Hospital of Los Angeles
Los Angeles, California, 90054
Mount Sinai Medical Center
New York, New York, 10128
University of California at San Francisco
San Francisco, California, 94143
University of South Florida
Tampa, Florida, 33606
Childrens Hospital National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Community Mobilization
- Keywords
- HIV, AIDS, Adolescent, Community, Structural Changes, HIV Seronegativity
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community MobilizationBehavioural
Also called No other names
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."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Mobilization | |
| 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. Receives: Behavioral: Community Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startFeb 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Jonathan Ellen, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271908
- Sponsor's protocol ID
- ATN 040b
- Status last verified
- Mar 2016
- First submitted
- 30 Dec 2005
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation
- ClinicalTrials.gov ID
- NCT00271908
- Acronym / sponsor ID
- ATN 040b
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Adolescent, Community, Structural Changes, HIV Seronegativity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,472 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort #1 | – | Behavioral: Community MobilizationVenue-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 | – | Behavioral: Community MobilizationHIV-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. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community MobilizationAlso: No other namesATN 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." | Behavioural | Cohort #1, Cohort #2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Website for the Adolescent Trials Network for HIV/AIDS InterventionsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Ellen, MD study chair
Johns Hopkins University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.