Chicago, Illinois 60612

  • HIV Infection

Purpose:

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.


Study 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 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.


Criteria:

Inclusion Criteria: 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 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 Exclusion Criteria: - 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


Study is Available At:


Original ID:

ATN 016b


NCT ID:

NCT00103896


Secondary ID:


Study Acronym:


Brief Title:

Connect to Protect Partnerships for Youth Prevention Interventions: Phase II


Official Title:

Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

12 Years


Maximum Age:

24 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

16706


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jonathan Ellen, MD
Study Chair
Johns Hopkins Medical Center

Study Dates

Start Date:September 2003
Completion Date:October 2010
Completion Type:Actual
Primary Completion Date:October 2010
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:February 27, 2017
First Received Date:February 15, 2005

Study Outcomes

Outcome Type: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
Safety Issues:False
Description: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 info
Outcome Type:Primary Outcome
Measure:Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
Time Frame:One time assessment at 10 months
Safety Issues:False
Description:The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Outcome Type:Primary Outcome
Measure:Describe social networks of adolescents and young adults recruited from targeted venues
Time Frame:One time assessment at 10 months
Safety Issues:False
Description:The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Outcome Type:Primary Outcome
Measure:Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
Time Frame:One time assessment at 10 months
Safety Issues:False
Description:The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
Outcome Type:Primary Outcome
Measure:Assess the characteristics of the community-researcher partnerships
Time Frame:One time assessment at 10 months
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Assess quality of the community-researcher partnerships
Time Frame:One time assessment at 10 months
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Assess outcomes of the community-researcher partnerships
Time Frame:One time assessment at 10 months
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:HIV Infected Youth in Treatment/Care
Description: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).
Study Arm Type:Other
Arm Name:BVI Individuals
Description: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).
Study Arm Type:Other
Arm Name:HIV Serosurvey Individuals
Description: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)..

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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