Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission
The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are:
- Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH?
- Does community-based and DSD TPT reduce household and community TB transmission?
Researchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion.
Participants will:
- Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures.
- If eligible, receive DSD TPT service delivery or SoC TPT service delivery.
- Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up.
- Have TPT completion assessed at 12 weeks following enrolment.
- A subset of participants will be assess for TB incidence at 9 months following enrolment.
연구 개요
상태
상세 설명
We will conduct a two-arm, non-blinded, randomized controlled trial (RCT) comparing differentiated TPT delivery to standard of care (SOC) clinic-based TPT. Our central hypothesis is that decentralized, differentiated-service delivery approaches to TPT will improve TPT uptake and completion in Kenya. This study will be conducted in seven HIV clinics in Kisumu County, a high HIV/TB burden region in western Kenya. This study has two populations:
(A) Household contacts (HHC) of Index TB patients (Index patients: any age, diagnosed with pulmonary TB (or any TB if <18 years), who live with at least one other person not currently taking TB treatment). The TB index patients and household contacts include children.
(B) People living with HIV (PWH), aged 15+ who are eligible for TPT per Kenyan guidelines.
The primary outcome, 3 months after enrollment, is completion of a course of TPT, defined as taking 11 weeks of TPT within 16 weeks.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Gillian O'Bryan
- 전화번호: 240-444-0098
- 이메일: gilliano@uw.edu
연구 연락처 백업
- 이름: Adrienne Shapiro, MD, PhD
- 이메일: aeshapir@uw.edu
연구 장소
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-
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Kisumu, 케냐
- Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital
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연락하다:
- Celestine Atieno
- 전화번호: +254 713 053766
- 이메일: catien00@uw.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Household contacts (HHC) are eligible for enrolment if they share a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).
- People living with HIV (PWH) are eligible for enrolment if they are adults aged 15 and over, are eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.
Exclusion Criteria:
- HHC will be excluded if they plan on permanently relocating from the area within the next three months, are not willing to receive TPT screening and initiation at home, or are enrolled in any other investigational/interventional HIV or TB study.
- PWH will be excluded if they plan on permanently relocated from the area within the next three months, have contraindications for TPT according to the Kenyan National Guidelines, or are enrolled in any other investigational/interventional HIV or TB study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Differentiated service delivery (DSD) of TPT
In the household contact (HHC) population DSD TPT will be delivered at home in a single dispense of a full course of TPT; in the people living with HIV (PWH) population DSD TPT will be delivered at the clinic in a single dispense of a full course of TPT.
|
TPT is normally provided at clinics with monthly visits for refills, but the full course of TPT can also be provided all at once through differentiated service delivery (DSD) of TPT.
By doing the Kulindana study, we hope to learn which way of delivering TPT to clients (through usual clinic practice, or all at once) is best for helping people finish their full course of TPT.
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간섭 없음: Clinic-based standard of care
Both the household contact (HHC) population and the people living with HIV (PWH) population have TPT dispensed at the clinic according to standard practice, typically one month at a time.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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TB preventive therapy completion
기간: 16 weeks
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Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks
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16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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IGRA conversion
기간: 9 months
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Proportion of child household contacts (age <15 years) who convert their IGRA result from negative to positive.
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9 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Adrienne Shapiro, MD, PhD, University of Washington
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00024388
- R01AI183979-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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