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

NCT01203332 | Completed

• 1 other identifier: ATN 096
• Study Type: observational
• Target: 1,917
• Locations: 2 countries
• Sites: 13

Brief Summary

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.

Conditions

HIV

Keywords

HIV testing; Latino; Latina; Men who have sex with men

Outcome Measures

Primary Outcomes (3)

• Effectiveness of AVT strategy with SSNIT

  To compare the relative effectiveness of AVT with SSNIT, which is a coupon-based index recruiter driven network recruitment strategy for identifying previously undiagnosed HIV infection among Hispanic/Latino adolescents and young adults aged 13-24 years.

  2 years

• Facilitators & barriers to HIV testing

  To examine factors that facilitate and/or hinder Hispanic/Latino adolescents and young adults in getting an HIV test (e.g., perceived risk for HIV, acculturation, homophobia, stigma associated with IDU).

  2 years

• Sub-group differences

  To explore the extent to which sub-group differences (e.g., origin of birth, age, level of acculturation) exist by prevalence of HIV-related risk behaviors, HIV testing, and mode of HIV transmission.

  2 years

Study Arms (3)

Alternative Venue Testing (AVT)

Participants recruited for testing through the AVT recruitment method.

Behavioral: Effectiveness of different strategies in HIV testing and linkage to care

SSNIT - Index Recruiter

Participants recruited for HIV testing and to bring members of their social and sexual network to the study.

Behavioral: Effectiveness of different strategies in HIV testing and linkage to care

SSNIT - Network Member

Participants recruited by someone in their social or sexual network to participate in the study, including HIV testing.

Behavioral: Effectiveness of different strategies in HIV testing and linkage to care

Interventions

Effectiveness of different strategies in HIV testing and linkage to care BEHAVIORAL

HIV testing Linkage to Care

Alternative Venue Testing (AVT); SSNIT - Index Recruiter; SSNIT - Network Member

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent and young adult Hispanic/Latino MSM and heterosexual men and women, aged 13-24 years, who meet all eligibility requirements for enrollment into the AVT or SSNIT component of the study.

You may qualify if:

• a. 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.
• b. 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

You may not qualify if:

• a. 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.
• Self-reports a prior diagnosis of HIV

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (13)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of California San Francisco

San Francisco, California, 94117, United States

Location

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Childrens Diagnostic & Treatment Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami School of Medicine

Miami, Florida, 33101, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, 60612, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Mount Sinai Medical Center

New York, New York, 10128, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Childrens Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

University of Puerto Rico

San Juan, 00936-5067, Puerto Rico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Homosexuality

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Cherrie B. Boyer, Ph.D.

  Adolescent Trials Network

  STUDY CHAIR

• Jonathan M. Ellen, M.D.

  Adolescent Trials Network

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 28, 2017

Record last verified: 2016-03

Locations

US (12); PR (1)