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

• ClinicalTrials.gov Identifier: NCT01203332
• Recruitment Status: Completed
• First Posted: September 16, 2010
• Last Update Posted: February 28, 2017
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment
HIV	Behavioral: Effectiveness of different strategies in HIV testing and linkage to care

Study Design

• Study Type: Observational
• Actual Enrollment: 1917 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults
• Study Start Date: July 2010
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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.	Behavioral: 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.	Behavioral: Effectiveness of different strategies in HIV testing and linkage to care; HIV testing Linkage to Care

Outcome Measures

Primary Outcome Measures :

1. Effectiveness of AVT strategy with SSNIT [ Time Frame: 2 years ]
   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. Facilitators & barriers to HIV testing [ Time Frame: 2 years ]
   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).
3. Sub-group differences [ Time Frame: 2 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 24 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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

Contacts and Locations

Locations

United States, California

Childrens Hospital Los Angeles

Los Angeles, California, United States, 90027

University of California San Francisco

San Francisco, California, United States, 94117

United States, District of Columbia

Childrens National Medical Center

Washington, District of Columbia, United States, 20010

United States, Florida

Childrens Diagnostic & Treatment Center

Fort Lauderdale, Florida, United States, 33316

University of Miami School of Medicine

Miami, Florida, United States, 33101

University of South Florida

Tampa, Florida, United States, 33606

United States, Illinois

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, United States, 60612

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

Mount Sinai Medical Center

NY, New York, United States, 10128

United States, Pennsylvania

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

United States, Tennessee

St. Jude Childrens Research Hospital

Memphis, Tennessee, United States, 38105-2794

Puerto Rico

University of Puerto Rico

San Juan, Puerto Rico, 00936-5067

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Investigators

• Study Chair: Cherrie B. Boyer, Ph.D.; Adolescent Trials Network
• Study Chair: Jonathan M. Ellen, M.D.; Adolescent Trials Network

More Information

Additional Information:

Related Info 

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01203332
• Other Study ID Numbers: ATN 096
• First Posted: September 16, 2010
• Last Update Posted: February 28, 2017
• Last Verified: March 2016

Keywords provided by University of North Carolina, Chapel Hill:

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

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases