Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults
NCT ID: NCT01203332
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1917 participants
OBSERVATIONAL
2010-07-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
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Alternative Venue Testing (AVT)
Participants recruited for testing through the AVT recruitment method.
Effectiveness of different strategies in HIV testing and linkage to care
HIV testing Linkage to Care
SSNIT - Index Recruiter
Participants recruited for HIV testing and to bring members of their social and sexual network to the study.
Effectiveness of different strategies in HIV testing and linkage to care
HIV testing Linkage to Care
SSNIT - Network Member
Participants recruited by someone in their social or sexual network to participate in the study, including HIV testing.
Effectiveness of different strategies in HIV testing and linkage to care
HIV testing Linkage to Care
Interventions
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Effectiveness of different strategies in HIV testing and linkage to care
HIV testing Linkage to Care
Eligibility Criteria
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Inclusion Criteria
* Self-identifies as being of Hispanic or Latino ethnicity;
* Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
* Self-reports a negative or unknown HIV status;
* Is male and self-reports any unprotected anal sex with a male sexual partner in the past three months; OR Is female and self-reports any unprotected anal or vaginal sex with two or more male sexual partners in the past three months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an injection drug user in the past 12 months;
* Willing to complete an HIV risk assessment;
* Willing to undergo HIV screening; and
* Able to understand and willing to provide signed informed consent/assent in English or Spanish.
1b. Social and Sexual Index Recruiter Participants
* Self-identifies as being of Hispanic or Latino ethnicity;
* Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
* Is male or female and self-reports being diagnosed with HIV in the past 12 months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an injection drug user in the past 12 months;
* Willing to complete a HIV risk assessment;
* Willing to undergo HIV screening (or an HIV confirmatory test if previously diagnosed);
* Willing to recruit one or more Latino/Latina family members, friends, or sexual partners who are between the ages of 13-24 years and who meet the criteria for a Social and Sexual Network Member for participation in the study; and
* Able to understand and willing to provide signed informed consent/assent in English or Spanish.
1c. Social and Sexual Network Members
* Self-identifies as being of Hispanic or Latino ethnicity;
* Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
* Self-reports any anal or vaginal sexual activity in the past 3 months and any unprotected anal or vaginal sex in the last 12 months; OR Self-reports any history of injection drug use;
* Willing to complete a HIV risk assessment;
* Willing to undergo HIV screening; and
* Able to understand and willing to provide signed informed consent/assent in English or Spanish.
* Is male or female and self-reports being diagnosed with HIV in the past 12 months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an IDU in the past 12 months; and
* Willing to recruit one or more Latino/Latina family members, friends, or sexual partners who are between the ages of 13-24 years and who meet the criteria for Social and Sexual Network Members for participation in the study.
Exclusion Criteria
* Previous participation in ATN 096 as an AVT or a SSNIT study participant;
* Current or prior participation in ATN 084;
* Anything that would impair the participant's ability to provide informed consent/assent and/or interfere with the protocol's objectives; i.e., readily apparent psychiatric symptoms (hallucinations, thought disorder), visibly distraught (suicidal, homicidal, exhibiting violent behavior) or visibly intoxicated or under the influence of alcohol or other substances at the time of study enrollment, and
* Acute illness that, in the opinion of study staff, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.
* Self-reports a prior diagnosis of HIV
13 Years
24 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Cherrie B. Boyer, Ph.D.
Role: STUDY_CHAIR
Adolescent Trials Network
Jonathan M. Ellen, M.D.
Role: STUDY_CHAIR
Adolescent Trials Network
Locations
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Childrens Hospital Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Childrens Diagnostic & Treatment Center
Fort Lauderdale, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Mount Sinai Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States
University of Puerto Rico
San Juan, , Puerto Rico
Countries
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Related Links
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Related Info
Other Identifiers
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ATN 096
Identifier Type: -
Identifier Source: org_study_id
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