HIV InfectionNCT00103896
Connect to Protect Partnerships for Youth Prevention Interventions: Phase II
An observational study of HIV Infection, run by University of North Carolina, Chapel Hill at 15 sites in 2 countries.
Trial summary
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities. Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- How many people
- 16,706 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Sep 2003to Oct 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: HIV infected youth, ages 12 through 24 years old, in treatment/care at each of the 15 ATN sites will be interviewed using ACASI technology to reveal possible venues where youth at high risk for acquiring the HIV may be found. Individuals approached at 3-5 of these identified venues who appear to be 12 through 24 years will be offered a brief venue interview. Anonymous HIV serosurvey (ACASI and HIV-Ab assay) will be administered to 20-30 young women at 2-3 identified high-risk venues, and 20-30 young men at 2-3 identified high-risk venues, who provide verbal confirmation of being 12 through 24 years old, and whose HIV status is unknown to the site staff.
Who may be able to join
- Index Subjects:
- Documented HIV-infection
- Acquisition of HIV after age 9 years
- Verbal confirmation of 12-24 years of age
- Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
- Ability to understand and willingness to provide informed consent/assent
Show all 12Show fewer
- BVI subjects:
- Youths who appear to be 12-24 years old
- HIV Serosurvey subjects at the venues:
- Verbal confirmation of 12-24 years of age
- Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
- Ability to understand and willingness to provide informed consent/assent
Who cannot join
- Visibly distraught and/or emotionally unstable (i.e. depressive mood, exhibiting manic, suicidal or violent behavior, etc.)
- Visibly intoxicated or under the influence of psychoactive agents
- Clinically presents as acutely ill
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
University of Maryland
Baltimore, Maryland, 21201
Childrens' Hospital of Boston
Boston, Massachusetts, 02115
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Children's Diag. and Treatment Center
Fort Lauderdale, Florida, 33301
Childrens Hospital of Los Angeles
Los Angeles, California, 90054
University of Miami
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana, 70112
Mount Sinai Medical Center
New York, New York, 10128
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, 19104
UCSD Mother, Child & Adolescent HIV Program
San Diego, California, 92103
Univ of Califormia at San Francisco
San Francisco, California, 94143
USF Peds Div. of Infectious Disease
Tampa, Florida, 33606
Montefiore Medical Center, Adolescent AIDS Program
The Bronx, New York, 10467
Children's Hospital National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities.
This phase will describe specific locations within high-risk areas where youth, ages 12-24, spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at these venues will be assessed by administering anonymous computerized interviews to eligible and willing youth. This information will be shared with community partners during scheduled working group meetings.
Read the detailed description
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such ATN research activities.
During this phase, each ATN site will gather additional information within high-risk areas and solicit community partner input to ultimately pinpoint the specific locations where at-risk youths, ages 12-24, may be recruited for interventions. This will be done by the following methods:
Venues will be identified by HIV+ youth at the ATN site by participation in an anonymous computerized interview. Site staff will then perform brief venue interviews (BVIs) at selected venues to assess the potential yield of youths 12-24 years old. Community partners will also provide the site staff with information on known high-risk venues. High-risk venues will further be identified by the results of anonymous computerized interviews and HIV assays obtained from eligible and willing youth participants at the venues. The interviews will gather information on HIV risk behaviors, social networking patterns and HIV prevalence among youths at these venues. This information will be shared with community partners during scheduled working group meetings.
- Conditions
- HIV Infection
- Keywords
- High-risk youth, HIV infected youth, Community mobilization, HIV serosurveys
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV Infected Youth in Treatment/Care | HIV infected youth in treatment/care will be interviewed using Audio Computer-Assisted Self-Administered Interview ACASI technology to reveal possible venues where youth at high risk for acquiring the disease may be found (N = 20-30 individuals per ATN site). | |
| BVI Individuals | Additional data will be gathered on potential recruitment venues by administering a brief venue interview (BVI) to individuals who appear to be between 12 and 24 years old (N = unlimited individuals during 3-5 assessment periods per venue each lasting 5 hours). | |
| HIV Serosurvey Individuals | HIV Serosurvey Individuals Anonymous structured interview using ACASI technology and an anonymous HIV antibody assay will be administered to 20-30 young women at 2-3 targeted locations and 20-30 young men at 2-3 targeted locations whose HIV status is unknown (N = 160-360 individuals per ATN site).. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ascertain specific community venues where at-risk youth can be recruited for interventions within the high-risk areas identified in the first Phase of the study
The outcome measure will be assessed using results from: (a) Phase I mapping; (b) Phase II interviews with HIV-infected youth; and (c) Phase II Brief Venue Interviews (BVIs). Input from community partners and ethnographic procedures will add critical information.
Measured: One time assessment at 10 months
Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Measured: One time assessment at 10 months
Describe social networks of adolescents and young adults recruited from targeted venues
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Measured: One time assessment at 10 months
Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Measured: One time assessment at 10 months
Assess the characteristics of the community-researcher partnerships
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
Measured: One time assessment at 10 months
Assess quality of the community-researcher partnerships
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
Measured: One time assessment at 10 months
Assess outcomes of the community-researcher partnerships
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
Measured: One time assessment at 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2005 (estimated)
- Study startSep 2003
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 16,706 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 Medical CenterLigia Peralta, MD, Principal investigator, Division of Adolescent & Young Adult Medicine University of MD, Medical SchoolDonna Futterman, MD, Principal investigator, Montefiore Medical CenterMarvin Belzer, MD, Principal investigator, Childrens Hosp of Los Angeles, Division of Adolescent MedicineBret Rudy, MD, Principal investigator, Children's Hospital of PhiladelphiaLarry D'Angelo, MD, Principal investigator, Children's National Research InstituteCathryn Samples, MD, Principal investigator, Boston Children's HospitalLisa Henry-Reid, MD, Principal investigator, John H. Stroger Jr. Hospital and the CORE Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103896
- Sponsor's protocol ID
- ATN 016b
- Status last verified
- Jul 2016
- First submitted
- 15 Feb 2005
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II
- ClinicalTrials.gov ID
- NCT00103896
- Acronym / sponsor ID
- ATN 016b
- Conditions
- HIV Infection
- Keywords
- High-risk youth, HIV infected youth, Community mobilization, HIV serosurveys
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,706 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
- Sep 2003
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Feb 2005 (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.
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities.
This phase will describe specific locations within high-risk areas where youth, ages 12-24, spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at these venues will be assessed by administering anonymous computerized interviews to eligible and willing youth. This information will be shared with community partners during scheduled working group meetings.
Detailed description
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such ATN research activities.
During this phase, each ATN site will gather additional information within high-risk areas and solicit community partner input to ultimately pinpoint the specific locations where at-risk youths, ages 12-24, may be recruited for interventions. This will be done by the following methods:
Venues will be identified by HIV+ youth at the ATN site by participation in an anonymous computerized interview. Site staff will then perform brief venue interviews (BVIs) at selected venues to assess the potential yield of youths 12-24 years old. Community partners will also provide the site staff with information on known high-risk venues. High-risk venues will further be identified by the results of anonymous computerized interviews and HIV assays obtained from eligible and willing youth participants at the venues. The interviews will gather information on HIV risk behaviors, social networking patterns and HIV prevalence among youths at these venues. This information will be shared with community partners during scheduled working group meetings.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV Infected Youth in Treatment/Care | – | –HIV infected youth in treatment/care will be interviewed using Audio Computer-Assisted Self-Administered Interview ACASI technology to reveal possible venues where youth at high risk for acquiring the disease may be found (N = 20-30 individuals per ATN site). |
| BVI Individuals | – | –Additional data will be gathered on potential recruitment venues by administering a brief venue interview (BVI) to individuals who appear to be between 12 and 24 years old (N = unlimited individuals during 3-5 assessment periods per venue each lasting 5 hours). |
| HIV Serosurvey Individuals | – | –HIV Serosurvey Individuals Anonymous structured interview using ACASI technology and an anonymous HIV antibody assay will be administered to 20-30 young women at 2-3 targeted locations and 20-30 young men at 2-3 targeted locations whose HIV status is unknown (N = 160-360 individuals per ATN site).. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- HIV infected youth, ages 12 through 24 years old, in treatment/care at each of the 15 ATN sites will be interviewed using ACASI technology to reveal possible venues where youth at high risk for acquiring the HIV may be found. Individuals approached at 3-5 of these identified venues who appear to be 12 through 24 years will be offered a brief venue interview. Anonymous HIV serosurvey (ACASI and HIV-Ab assay) will be administered to 20-30 young women at 2-3 identified high-risk venues, and 20-30 young men at 2-3 identified high-risk venues, who provide verbal confirmation of being 12 through 24 years old, and whose HIV status is unknown to the site staff.
Key inclusion criteria (12 listed)
- Documented HIV-infection
- Acquisition of HIV after age 9 years
- Verbal confirmation of 12-24 years of age
- Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
- Ability to understand and willingness to provide informed consent/assent
Key exclusion criteria (3 listed)
- Visibly distraught and/or emotionally unstable (i.e. depressive mood, exhibiting manic, suicidal or violent behavior, etc.)
- Visibly intoxicated or under the influence of psychoactive agents
- Clinically 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.
Primary outcome
Ascertain specific community venues where at-risk youth can be recruited for interventions within the high-risk areas identified in the first Phase of the study
Time frame: One time assessment at 10 months
The outcome measure will be assessed using results from: (a) Phase I mapping; (b) Phase II interviews with HIV-infected youth; and (c) Phase II Brief Venue Interviews (BVIs). Input from community partners and ethnographic procedures will add critical information.
Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
Time frame: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Describe social networks of adolescents and young adults recruited from targeted venues
Time frame: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
Time frame: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Assess the characteristics of the community-researcher partnerships
Time frame: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
Assess quality of the community-researcher partnerships
Time frame: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
Assess outcomes of the community-researcher partnerships
Time frame: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
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 1 Mar 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 Medical Center
Ligia Peralta, MD principal investigator
Division of Adolescent & Young Adult Medicine University of MD, Medical School
Donna Futterman, MD principal investigator
Montefiore Medical Center
15 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 Infection, run by University of North Carolina, Chapel Hill at 15 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 12 inclusion and 3 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Ascertain specific community venues where at-risk youth can be recruited for interventions within the high-risk areas identified in the first Phase of the study (time frame: One time assessment at 10 months). The study lists 7 primary outcomes in all. 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 1 Mar 2017.