Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT02438592
Eligibility Criteria:
Inclusion Criteria:
* Laboratory evidence of HIV-1 infection per Centers for Disease Control and Prevention (CDC) Surveillance Case Definition for HIV Infection, 2014 (Section 1.1) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm;
* Behaviorally-acquired HIV after age 9 years;
* Age 13 through 24 years, inclusive, at the baseline visit (Enrollment);
* Planning to receive HIV medical care at an AMTU or at any clinical site that is part of the AMTU for the duration of study follow-up
• If transition to an adult health care provider must occur during the course of study participation, continued AMTU staff accessibility to medical and appointment records;
* Ability for the AMTU staff to access medical and appointment records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first;
* Ability to understand spoken English;
* Willing and able to provide signed informed consent or assent;
NOTE: If consent/assent is obtained \> 4 weeks prior to the enrollment date, reaffirmation of consent must be obtained prior to starting the Baseline visit.
-Parent or Legal Guardian permission, if applicable; and
In addition to all the criteria listed above, to be considered eligible for enrollment after August 31, 2015, an individual must also meet the following criterion.
-Must be considered either: (a) newly engaged in HIV medical care defined as no previous initial comprehensive HIV medical care visit with consent occurring before, at the time of, or within four weeks following that initial comprehensive visit; or (b) newly re-engaged in HIV medical care defined as attending the last medical appointment more than 52 weeks ago.
\*NOTE: The initial HIV medical care appointment is defined as a routine HIV medical appointment where the adolescent attends with a medical provider authorized to prescribe medication.
This HIV medical appointment must be a non-emergency, routine condition-focused exam AND one or more of the following:
* CD4, VL lab draw and/or review of these lab results;
* Discussion around HIV ART options;
* Primary and/or secondary HIV prevention education and counseling; or
* Diagnosis and treatment of complications of HIV, and of AIDS-defining conditions.
Exclusion Criteria:
* Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent or participate in the baseline ACASI\*;
* Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent or the baseline ACASI\*; or
* Intoxicated or under the influence of alcohol or other substances at the time of consent or the baseline ACASI\*
* NOTE: If consent/assent is obtained prior to the enrollment date, assessment for these exclusion criteria must be performed again prior to administration of the baseline ACASI (Enrollment). If any are present, the subject cannot be enrolled; do not administer the ACASI. Reassessment of eligibility and enrollment may take place at a later date per the discretion of the treating clinician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
24 Years
Study:
NCT02438592
Study Brief:
Protocol Section:
NCT02438592