Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:13 - 24
Updated:3/1/2017
Start Date:July 2010
End Date:January 2013

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The proposed research will include adolescent and young adult Hispanic/Latino men who have
sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13
ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial
services to the target group. In 10 of the 13 sites, comparisons will be made between
alternative venue-based testing (AVT) and social and sexual network-based interviewing and
HIV testing (SSNIT) strategies to assess which, among these approaches, is the most
effective means for identifying undiagnosed human immunodeficiency virus (HIV) in young,
at-risk Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for
identifying undiagnosed HIV in our target group of adolescents and young adults. All study
participants will complete an audio computer-assisted self-interview (ACASI) and undergo HIV
screening. Participants with presumptive HIV positive screening results will be referred to
the local AMTU for confirmatory testing, post-test counseling and referrals for linkage to
HIV medical care. Linkage to care for ATN 096 study participants will be conducted in
accordance with the Strategic Multisite Initiative for the Identification, Linkage, and
Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH)
Program (ATN 093), a collaboration of the CDC and NICHD/ATN, to ensure that youth who test
positive for HIV as part of this protocol are linked with treatment and care.


1. Inclusion Criteria

1a. Alternative Venue-Based Testing (AVT) 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;

- 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.

1d. Additional Inclusion Criteria for Social and Sexual Network Member Recruiters

- 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.

2. Exclusion Criteria

2a. All Participants

- 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.

2b. Additional Exclusion Criteria for Alternative Venue-Based Testing Participants

- Self-reports a prior diagnosis of HIV
We found this trial at
13
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
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1401 South Federal Highway
Fort Lauderdale, Florida 33301
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Chicago, IL
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NY, New York 10029
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San Francisco, California 94143
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San Francisco, CA
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San Juan, 36506
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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