- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02438592
PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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Aurora, California, Forenede Stater, 80045
- University of Colorado/The Children's Hospital
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Los Angeles, California, Forenede Stater, 90027
- Children's Hopsital of Los Angeles
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Children's Hospital National Medical Center
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Florida
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Miami, Florida, Forenede Stater, 33101
- University of Miami School of Medicine
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Tampa, Florida, Forenede Stater, 33606
- University of South Florida
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University Health Sciences Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Fenway Institute
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Children's Hospital of Michigan
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New York
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Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children'S Research Hospital
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Texas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine/Texas Children's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
- Behaviorally-infected, HIV-positive adolescents and young adults who are currently receiving or plan to receive their medical care at any clinical site that is part of the AMTU;
- Ages 13 through 24, inclusive, at the Baseline visit;
- Males and females;
- Ability to understand spoken English; and
- Ability for the AMTU staff to access the subject's medical records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure
Tidsramme: Baseline
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Baseline
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The proportion of subjects engaged in care at Week 26, per subject year, as defined by the HRSA HAB measure
Tidsramme: Week 26
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Week 26
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The proportion of subjects engaged in care at Week 52, per subject year, as defined by the HRSA HAB measure
Tidsramme: Week 52
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Week 52
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The proportion of subjects engaged in care at Week 78, per subject year, as defined by the HRSA HAB measure
Tidsramme: Week 78
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Week 78
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The proportion of subjects engaged in care at Baseline, per subject year, as defined by the DHHS measure
Tidsramme: Baseline
|
Baseline
|
The proportion of subjects engaged in care at Week 26, per subject year, as defined by the DHHS measure
Tidsramme: Week 26
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Week 26
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The proportion of subjects engaged in care at Week 52, per subject year, as defined by the DHHS measure
Tidsramme: Week 52
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Week 52
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The proportion of subjects engaged in care at Week 78, per subject year, as defined by the DHHS measure
Tidsramme: Week 78
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Week 78
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The proportion of subjects prescribed antiretroviral therapy at Baseline per subject year
Tidsramme: Baseline
|
Baseline
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The proportion of subjects prescribed antiretroviral therapy at Week 26 per subject year
Tidsramme: Week 26
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Week 26
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The proportion of subjects prescribed antiretroviral therapy at Week 52 per subject year
Tidsramme: Week 52
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Week 52
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The proportion of subjects prescribed antiretroviral therapy at Week 78 per subject year
Tidsramme: Week 78
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Week 78
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The proportion of subjects that have achieved viral suppression at Baseline per subject year
Tidsramme: Baseline
|
Baseline
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The proportion of subjects that have achieved viral suppression at Week 26 per subject year
Tidsramme: Week 26
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Week 26
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The proportion of subjects that have achieved viral suppression at Week 52 per subject year
Tidsramme: Week 52
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Week 52
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The proportion of subjects that have achieved viral suppression at Week 78 per subject year
Tidsramme: Week 78
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Week 78
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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The proportion of subjects with advanced HIV disease at time of first clinical visit defined as a CD4 count < 200 cells/mm3
Tidsramme: Baseline
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Baseline
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The incidence of STIs in the study population as an indicator of transmission risk at Baseline
Tidsramme: Baseline
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Baseline
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The incidence of STIs in the study population as an indicator of transmission risk at Week 26
Tidsramme: Week 26
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Week 26
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The incidence of STIs in the study population as an indicator of transmission risk at Week 52
Tidsramme: Week 52
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Week 52
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The incidence of STIs in the study population as an indicator of transmission risk at Week 78
Tidsramme: Week 78
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Week 78
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Number of subjects with mental health issues at Baseline
Tidsramme: Baseline
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Baseline
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Number of subjects engaging in substance use at Baseline
Tidsramme: Baseline
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Baseline
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Number of subjects engaging in sexual risk behaviors at Baseline
Tidsramme: Baseline
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Baseline
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ART adherence rate at Baseline
Tidsramme: Baseline
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Baseline
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Frequency of missed clinic visits at Baseline
Tidsramme: Baseline
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Baseline
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Frequency of missed clinic visits at Week 26
Tidsramme: Week 26
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Week 26
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Frequency of missed clinic visits at Week 52
Tidsramme: Week 52
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Week 52
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Frequency of missed clinic visits at Week 78
Tidsramme: Week 78
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Week 78
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Types of services available at each AMTU at Baseline
Tidsramme: Baseline
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Baseline
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Types of services available at each AMTU at 48 weeks after Baseline
Tidsramme: Week 48
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Week 48
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Types of services available at each AMTU at 96 weeks after Baseline
Tidsramme: Week 96
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Week 96
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Proportion of subjects notifying their sexual partners after learning their HIV status
Tidsramme: Baseline
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Baseline
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Timing of subjects notifying their partners after learning about their HIV status
Tidsramme: Baseline
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Baseline
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Proportion of subjects with whom partner notification was discussed
Tidsramme: Baseline
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Baseline
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bret Rudy, MD, NYU Langone Health
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- ATN 125
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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