Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103896
• Other study ID #: ATN 016b
• Status: Completed
• Phase: N/A
• First received: February 15, 2005
• Last updated: February 27, 2017
• Start date: September 2003
• Est. completion date: October 2010

Study information

• Verified date: July 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16706
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
Puerto Rico	University Pediatric Hospital	San Juan
United States	University of Maryland	Baltimore	Maryland
United States	Childrens' Hospital of Boston	Boston	Massachusetts
United States	Montefiore Medical Center, Adolescent AIDS Program	Bronx	New York
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Children's Diag. and Treatment Center	Ft. Lauderdale	Florida
United States	Childrens Hospital of Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Children's Hopsital of Philadelphia	Philadelphia	Pennsylvania
United States	UCSD Mother, Child & Adolescent HIV Program	San Diego	California
United States	Univ of Califormia at San Francisco	San Francisco	California
United States	USF Peds Div. of Infectious Disease	Tampa	Florida
United States	Children's Hospital National Medical Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One time assessment at 10 months
Primary	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.	One time assessment at 10 months
Primary	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.	One time assessment at 10 months
Primary	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.	One time assessment at 10 months
Primary	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.	One time assessment at 10 months
Primary	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.	One time assessment at 10 months
Primary	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.	One time assessment at 10 months

External Links

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