Status:
COMPLETED
Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
HIV
Eligibility:
All Genders
13-24 years
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 M...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
1917 Patients enrolled
Trial Details
Trial ID
NCT01203332
Start Date
July 1 2010
End Date
January 1 2013
Last Update
February 28 2017
Active Locations (13)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of California San Francisco
San Francisco, California, United States, 94117
3
Childrens National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Childrens Diagnostic & Treatment Center
Fort Lauderdale, Florida, United States, 33316