Timing of Referral to Adherence Clubs for Antiretroviral Therapy (TRAC)
Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial
연구 개요
상세 설명
Following on from the huge need for scaled-up models of ART (anti-retroviral therapy) delivery to improve patient adherence and viral suppression, the ART adherence club model was piloted from 2007 with the aim of assessing whether this group-based, lay-counsellor led service, with an emphasis on social support and adherence, could help address retention in care and viral suppression. Since the initial pilots, the club model has been scaled up rapidly with more than 400 clubs meeting in the Cape Town metro. As this model is being scaled-up and implemented rapidly, there is an urgent necessity to further assess its effectiveness.
Whilst adherence clubs have been shown to be locally implementable, popular (with buy-in by clinic staff and patients) and cost-effective, and whilst community-based interventions have been shown to improve retention, evidence of local adherence club effectiveness in improving viral suppression and retention has only been observationally obtained. This observational evidence is highly subject to selection bias.
This trial aims to address this by using a randomised controlled trial design with two arms - ART patients receiving care in clinic as per the Standard-of-Care (this arm will have delayed referral to Adherence clubs at 12 months post-initiation) and ART patients receiving care in Adherence clubs (this arm will have early referral to Adherence clubs at 4 months post-initiation). By doing this the investigators hope to generate robust evidence regarding both the effectiveness of clubs and the optimal timing of club referral.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Western Cape
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Cape Town, Western Cape, 남아프리카, 7750
- Gugulethu Community Health Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Documented HIV infection with ART initiation 4 months ago
- Suppressed viral load at 4 months post-initiation (<400 copies/ml)
- All other month 4 blood results within normal limits
- Willingness to be randomised and return for study measurement visits
- Able to willing to attend service visits at either the clinic or a club
- Able to provide informed consent for research
Exclusion Criteria:
- Intention to relocate out of Cape Town permanently during the study period
- Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study
- Pregnant
- Current co-morbidity requiring additional health care, either acutely eg tuberculosis or chronically eg hypertension
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Clinic-based Care
Clinic-based care is the current Standard-of-Care whereby newly initiated ART patients attend the ART clinic.
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실험적: Adherence Club Care
Adherence club care involves referral to community-based ART services in the form of Adherence clubs, which are led by community health workers and supported by ART clinic nurses.
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Participants will be referred to an Adherence Club at 4 months post-ART initiation.
Adherence club visits occur 2-4 monthly at a community hall near the Community Health Centre (CHC).
At routine visits, which last 1-2 hours, community health workers provide health education, weigh patients, ask about symptoms and dispense pre-packed ART.
Symptomatic patients are sent back to the ART clinic for clinician assessment.
An assigned nurse takes blood tests annually at each club, and then returns on the subsequent visit to perform a clinical assessment and check the results.
Patients requiring more follow-up or with high viral loads are referred back to the ART clinic at the CHC by the nurse.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Viral suppression
기간: Up to 12 months post-ART initiation
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Viral load <400 copies/ml with secondary analyses at other thresholds
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Up to 12 months post-ART initiation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Retention in care
기간: Up to 12 months post-ART initiation
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Numbers of missed visits and loss-to-follow up
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Up to 12 months post-ART initiation
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Physical and Mental Health
기간: Up to 12 months post-ART initiation
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As captured in the study visit questionnaires
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Up to 12 months post-ART initiation
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Acceptability of the ART service
기간: Up to 12 months post-ART initiation
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As captured in the study visit questionnaires
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Up to 12 months post-ART initiation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Landon Myer, MBChB PhD, University of Cape Town
간행물 및 유용한 링크
일반 간행물
- Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13.
- Grimsrud A, Sharp J, Kalombo C, Bekker LG, Myer L. Implementation of community-based adherence clubs for stable antiretroviral therapy patients in Cape Town, South Africa. J Int AIDS Soc. 2015 May 27;18(1):19984. doi: 10.7448/IAS.18.1.19984. eCollection 2015.
- Grimsrud A, Lesosky M, Kalombo C, Bekker LG, Myer L. Implementation and Operational Research: Community-Based Adherence Clubs for the Management of Stable Antiretroviral Therapy Patients in Cape Town, South Africa: A Cohort Study. J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e16-23. doi: 10.1097/QAI.0000000000000863.
- Takuva S, Brown AE, Pillay Y, Delpech V, Puren AJ. The continuum of HIV care in South Africa: implications for achieving the second and third UNAIDS 90-90-90 targets. AIDS. 2017 Feb 20;31(4):545-552. doi: 10.1097/QAD.0000000000001340.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
키워드
기타 연구 ID 번호
- 764/2016
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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