적응형 무작위 통제 시험 (ADAP-TIV)
2026년 5월 26일 업데이트: Max O'Donnell, Columbia University
남아공에서 약물 내성 결핵 및 HIV에 대한 새로운 치료 요법으로 결과를 최적화하기 위한 mHealth 및 기존 순응 지원 개입의 적응형 평가
이것은 베다퀼린 함유 다제내성 결핵 치료 요법을 시작하는 확인된 다제내성결핵 HIV가 있는 성인과 ART(통합효소 가닥 전이 억제제(INSTI)- 남아공 콰줄루-나탈(KwaZulu-Natal)
개입 무기에는 다음이 포함됩니다. 향상된 치료 표준; 심리사회적 지원; 셀룰러 지원 전자 선량 모니터링을 사용하는 mHealth; 결합된 mHealth 심리사회적 지원.
지원 수준은 차별화된 서비스 제공(DSD)에 기반한 치료 지원 요구 사항 평가를 사용하여 조정됩니다.
연구 개요
상세 설명
이 연구는 4군 베이지안 적응 시험 설계를 따를 것입니다. 환자가 등록되면 4개 부문 중 하나로 무작위 배정됩니다.
연구는 효율적인 등록 및 분석이 가능하도록 공통 구조 내에서 수행됩니다. 전체 구조는 차별화된 서비스 제공(DSD) 접근 방식을 통해 정보를 제공하는 mHealth 및 심리사회적 준수 지원 개입의 4가지 적응형 플랫폼입니다.
목표 1은 개입 요소를 개별적으로 또는 조합하여 비교할 수 있도록 베이지안 적응 설계를 사용하는 mHealth 및 심리사회적 순응 지원 개입에 대한 적응형 연구입니다. Aim 1 참가자는 무작위로 4개 그룹 중 하나로 배정되고 6개월의 개입 기간 동안 매달 추적된 다음 전화로 치료가 끝날 때까지 추가 직접 방문하여 주요 결과를 설정합니다. 1차 결과는 아래에 설명된 12개월의 결합된 임상/생물학적 결과입니다. 가설 1a는 모든 참가자를 활용하는 반면, 1b는 세분화된 EDM 측정 순응도가 필요하므로 mHealth 개입 부문(3+4)의 참가자만 활용합니다.
연구 유형
중재적
등록 (추정된)
360
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kogieleum Naidoo
- 전화번호: +27 31 260 4687
- 이메일: Kogie.Naidoo@caprisa.org
연구 연락처 백업
- 이름: Max O'Donnell, MD, MPH
- 이메일: mo2130@columbia.edu
연구 장소
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KwaZulu-Natal
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Durban, KwaZulu-Natal, 남아프리카, 4001
- 모병
- King DinuZulu Hospital
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연락하다:
- Max O'Donnell, MD, MPH
- 이메일: mo2130@columbia.edu
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연락하다:
- Kogieleum Naidoo
- 전화번호: +27 31 260 4684
- 이메일: Kogie.Naidoo@caprisa.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- MTB에 대한 배양 또는 분자 검사 양성
- HIV에 대해 양성인 분자 검사 또는 문서화된 HIV 양성 이력
- 분자에 의한 약물 감수성 검사(예: GeneXpert MTB/RIF) 또는 최소한 리팜피신 내성 결핵과 일치하는 기존 테스트,
- 등록 후 4주 이내에 베다퀼린 함유 결핵 요법으로 치료를 시작하고 BDQ로 처음 치료를 받는 경우
- 돌루테그라비르 함유 병용 항레트로바이러스 요법을 포함한 항레트로바이러스 요법(ART) 요법(즉, Tenofovir-Lamivudine-Dolutergravir), 또는 등록 4주 이내에 시작,
- isiZulu 또는 영어로 정보에 입각한 동의를 할 수 있는 능력
제외 기준:
- 임신
- 죄수
- IOR 또는 임상의의 재량
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 향상된 관리 기준
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다른: 심리사회적 지원
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적응형 무작위 플랫폼을 사용하여 임상 및 생물학적 종점에 대한 순응도 지원 개입의 효과를 비교합니다.
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다른: 모바일 헬스
Wisepill 장치는 2G/3G 셀룰러 네트워크를 사용하는 RT2000 셀룰러 지원 전자 필 박스입니다.
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적응형 무작위 플랫폼을 사용하여 임상 및 생물학적 종점에 대한 순응도 지원 개입의 효과를 비교합니다.
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다른: mHealth 및 심리사회적 지원
팔 2와 팔 3의 조합.
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적응형 무작위 플랫폼을 사용하여 임상 및 생물학적 종점에 대한 순응도 지원 개입의 효과를 비교합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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생물학적 결과
기간: 06개월
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결핵 배양 전환
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06개월
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임상 결과
기간: 12 개월
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활착
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12 개월
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생물학적 결과
기간: 12 개월
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HIV 바이러스 부하
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12 개월
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임상 결과
기간: 12 개월
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관리 유지
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12 개월
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생물학적 결과
기간: 12 개월
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결핵 배양 전환
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12 개월
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Max O'Donnell, MD, MPH, Columbia University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 3월 7일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2029년 4월 1일
연구 등록 날짜
최초 제출
2022년 11월 21일
QC 기준을 충족하는 최초 제출
2022년 11월 21일
처음 게시됨 (실제)
2022년 12월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 26일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AAAT8513
- CAP262 (기타 식별자: University of KwaZulu Natal-Biomedical Research Ethics Committee)
- 1R01AI167795 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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