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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203332
• Other study ID #: ATN 096
• Status: Completed
• Phase: N/A
• First received: September 15, 2010
• Last updated: February 27, 2017
• Start date: July 2010
• Est. completion date: January 2013

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1917
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	University of Maryland	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital	Chicago	Illinois
United States	Childrens Diagnostic & Treatment Center	Fort Lauderdale	Florida
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	St. Jude Childrens Research Hospital	Memphis	Tennessee
United States	University of Miami School of Medicine	Miami	Florida
United States	Mount Sinai Medical Center	NY	New York
United States	Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California San Francisco	San Francisco	California
United States	University of South Florida	Tampa	Florida
United States	Childrens National Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), 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	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
Primary	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
Primary	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

External Links

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