- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02438592
PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
California
-
Aurora, California, 미국, 80045
- University of Colorado/The Children's Hospital
-
Los Angeles, California, 미국, 90027
- Children's Hopsital of Los Angeles
-
-
District of Columbia
-
Washington, District of Columbia, 미국, 20010
- Children's Hospital National Medical Center
-
-
Florida
-
Miami, Florida, 미국, 33101
- University of Miami School of Medicine
-
Tampa, Florida, 미국, 33606
- University Of South Florida
-
-
Illinois
-
Chicago, Illinois, 미국, 60612
- Stroger Hospital of Cook County
-
-
Louisiana
-
New Orleans, Louisiana, 미국, 70112
- Tulane University Health Sciences Center
-
-
Maryland
-
Baltimore, Maryland, 미국, 21287
- Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- Fenway Institute
-
-
Michigan
-
Detroit, Michigan, 미국, 48201
- Children's Hospital of Michigan
-
-
New York
-
Bronx, New York, 미국, 10467
- Montefiore Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
-
-
Tennessee
-
Memphis, Tennessee, 미국, 38105
- St. Jude Children's Research Hospital
-
-
Texas
-
Houston, Texas, 미국, 77030
- Baylor College of Medicine/Texas Children's Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
- 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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure
기간: Baseline
|
Baseline
|
The proportion of subjects engaged in care at Week 26, per subject year, as defined by the HRSA HAB measure
기간: Week 26
|
Week 26
|
The proportion of subjects engaged in care at Week 52, per subject year, as defined by the HRSA HAB measure
기간: Week 52
|
Week 52
|
The proportion of subjects engaged in care at Week 78, per subject year, as defined by the HRSA HAB measure
기간: Week 78
|
Week 78
|
The proportion of subjects engaged in care at Baseline, per subject year, as defined by the DHHS measure
기간: Baseline
|
Baseline
|
The proportion of subjects engaged in care at Week 26, per subject year, as defined by the DHHS measure
기간: Week 26
|
Week 26
|
The proportion of subjects engaged in care at Week 52, per subject year, as defined by the DHHS measure
기간: Week 52
|
Week 52
|
The proportion of subjects engaged in care at Week 78, per subject year, as defined by the DHHS measure
기간: Week 78
|
Week 78
|
The proportion of subjects prescribed antiretroviral therapy at Baseline per subject year
기간: Baseline
|
Baseline
|
The proportion of subjects prescribed antiretroviral therapy at Week 26 per subject year
기간: Week 26
|
Week 26
|
The proportion of subjects prescribed antiretroviral therapy at Week 52 per subject year
기간: Week 52
|
Week 52
|
The proportion of subjects prescribed antiretroviral therapy at Week 78 per subject year
기간: Week 78
|
Week 78
|
The proportion of subjects that have achieved viral suppression at Baseline per subject year
기간: Baseline
|
Baseline
|
The proportion of subjects that have achieved viral suppression at Week 26 per subject year
기간: Week 26
|
Week 26
|
The proportion of subjects that have achieved viral suppression at Week 52 per subject year
기간: Week 52
|
Week 52
|
The proportion of subjects that have achieved viral suppression at Week 78 per subject year
기간: Week 78
|
Week 78
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
The proportion of subjects with advanced HIV disease at time of first clinical visit defined as a CD4 count < 200 cells/mm3
기간: Baseline
|
Baseline
|
The incidence of STIs in the study population as an indicator of transmission risk at Baseline
기간: Baseline
|
Baseline
|
The incidence of STIs in the study population as an indicator of transmission risk at Week 26
기간: Week 26
|
Week 26
|
The incidence of STIs in the study population as an indicator of transmission risk at Week 52
기간: Week 52
|
Week 52
|
The incidence of STIs in the study population as an indicator of transmission risk at Week 78
기간: Week 78
|
Week 78
|
Number of subjects with mental health issues at Baseline
기간: Baseline
|
Baseline
|
Number of subjects engaging in substance use at Baseline
기간: Baseline
|
Baseline
|
Number of subjects engaging in sexual risk behaviors at Baseline
기간: Baseline
|
Baseline
|
ART adherence rate at Baseline
기간: Baseline
|
Baseline
|
Frequency of missed clinic visits at Baseline
기간: Baseline
|
Baseline
|
Frequency of missed clinic visits at Week 26
기간: Week 26
|
Week 26
|
Frequency of missed clinic visits at Week 52
기간: Week 52
|
Week 52
|
Frequency of missed clinic visits at Week 78
기간: Week 78
|
Week 78
|
Types of services available at each AMTU at Baseline
기간: Baseline
|
Baseline
|
Types of services available at each AMTU at 48 weeks after Baseline
기간: Week 48
|
Week 48
|
Types of services available at each AMTU at 96 weeks after Baseline
기간: Week 96
|
Week 96
|
Proportion of subjects notifying their sexual partners after learning their HIV status
기간: Baseline
|
Baseline
|
Timing of subjects notifying their partners after learning about their HIV status
기간: Baseline
|
Baseline
|
Proportion of subjects with whom partner notification was discussed
기간: Baseline
|
Baseline
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Bret Rudy, MD, NYU Langone Health
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- ATN 125
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
에이즈에 대한 임상 시험
-
Hospital Clinic of Barcelona완전한
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation완전한파트너 HIV 테스트 | 부부 에이즈 상담 | 커플커뮤니케이션 | HIV 발병률카메룬, 도미니카 공화국, 그루지야, 인도
-
University of Minnesota빼는HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염미국
-
Michael HoelscherClinton Health Access Initiative Inc.; Instituto Nacional de Saúde (INS), Ministério da... 그리고 다른 협력자들모집하지 않고 적극적으로HIV, 신생아 HIV 조기 진단(EID), 현장 진료 검사(PoC)모잠비크, 탄자니아
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
-
Erasmus Medical Center모병
-
Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
-
Erasmus Medical Center아직 모집하지 않음
-
University of Maryland, BaltimoreNational Institute of Mental Health (NIMH); Albert Einstein College of Medicine; Yale University 그리고 다른 협력자들아직 모집하지 않음HIV 예방 | HIV 사전 노출 예방
-
Erasmus Medical Center모집하지 않고 적극적으로