Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)
2022년 5월 17일 업데이트: Professor Landon Myer, University of Cape Town
Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial
South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+").
There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period.
The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.
연구 개요
상세 설명
South Africa is implementing the policy of universal initiation of lifelong ART in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+") and given the high antenatal HIV seroprevalence, HIV-infected pregnant women represent the largest group of patients initiating ART in primary care facilities.
However, there are few well developed models of service delivery to support implementation.
There are particular concerns regarding the postpartum period, with multiple studies indicating high levels of non-retention in care and/or inadequate adherence to treatment postnatally.
Adherence Clubs (ACs) are an innovative but untested model of care based on chronic disease management strategies that emphasize social support, adherence to treatment and retention in care, rather than intensive clinical management, as the most important determinant of long-term health outcomes in stable patients in chronic care.
ACs have preliminarily been shown to to result in virologic outcomes that are similar to routine clinic services in patients stable on ART.
The investigators are conducting a pragmatic, randomised controlled trial to evaluate two different strategies for delivering HIV care and treatment services during the postpartum period to HIV-infected women who initiated ART during pregnancy.
Participants will be allocated to receive ART care at either local adult ART clinics, following the current standard of care, or the community-based adherence club system.
연구 유형
중재적
등록 (실제)
412
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
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
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
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- Documented HIV infection with ART initiation during the preceding antenatal period
- Within 70 days post-delivery
- Viral suppression documented in pregnancy with the most recent viral load <400 copies/mL within the last 3 months
- Willingness to be randomised and return for study measurement visits
- Able and willing to attend service visits at either a local ART treatment centre or the adherence club at Ikhwezi centre
- 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 including: refusal to take ART/antiretrovirals (ARVs) and/or denial of HIV status
- Loss of pregnancy/neonate at the time of eligibility determination
- Current co-morbidity requiring additional health care attention, including opportunistic infections such as tuberculosis (TB) disease or any chronic condition or other condition that is not controlled or stable
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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 and is defined as referral of women on antiretroviral therapy (ART) to general primary care adult ART services.
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실험적: Adherence Club Care
Adherence club care involves referral of women on ART 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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Women will be referred to the ACs at their postpartum ART clinic visit at the midwife obstetric unit (MOU) at the Gugulethu community health centre (CHC).
AC visits occur 2-4 monthly at a community hall near the CHC.
At routine visits, which last ~1 hour, community health workers provide health education, weigh participants, ask about symptoms, and dispense pre-packed ART.
Symptomatic participants are referred back to the main ART facility at the CHC for assessment by a nurse.
A nurse performs routine phlebotomy at an annual club visit, and does a clinical assessment and reviews blood results at the subsequent visit.
Participants requiring more regular follow-up and those with raised 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: 24 months
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Time to viral load >1000 copies per ml
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24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Maternal retention in care
기간: 24 months
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Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
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24 months
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Maternal death
기간: 24 months
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Maternal deaths over the study period
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24 months
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Maternal mental health
기간: 24 months
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Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
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24 months
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Maternal health care service use
기간: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant death
기간: 24 months
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Infant deaths over the study period
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24 months
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Infant health care service use
기간: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant HIV testing
기간: 24 months
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Uptake of routine infant HIV testing
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24 months
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Infant HIV infection
기간: 24 months
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Mother-to-child transmission of HIV
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24 months
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Infant feeding
기간: 24 months
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Breastfeeding practices
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24 months
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Cost and cost-effectiveness
기간: 24 months
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Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
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24 months
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Acceptability of each ART service
기간: 24 months
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Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
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24 months
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Viral suppression at other cutpoints (>400 copies/mL)
기간: 24 months
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Time to VL >400 copies/mL
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24 months
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Viral suppression at other cutpoints (>50 copies/mL)
기간: 24 months
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Time to VL >50 copies/mL
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24 months
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Virologic Failure
기간: 24 months
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Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)
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24 months
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Combined retention/VL outcome
기간: 24 months
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Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)
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24 months
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Viral suppression at each study visit
기간: 24 months
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VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
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24 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Landon Myer, MBChB PhD, University of Cape Town
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
- 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.
- Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, Mills EJ, Ho YS, Stringer JS, McIntyre JA, Mofenson LM. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012 Oct 23;26(16):2039-52. doi: 10.1097/QAD.0b013e328359590f.
- Kaplan R, Orrell C, Zwane E, Bekker LG, Wood R. Loss to follow-up and mortality among pregnant women referred to a community clinic for antiretroviral treatment. AIDS. 2008 Aug 20;22(13):1679-81. doi: 10.1097/QAD.0b013e32830ebcee.
- Coutsoudis A, Goga A, Desmond C, Barron P, Black V, Coovadia H. Is Option B+ the best choice? Lancet. 2013 Jan 26;381(9863):269-71. doi: 10.1016/S0140-6736(12)61807-8. No abstract available.
- Chi BH, Stringer JS, Moodley D. Antiretroviral drug regimens to prevent mother-to-child transmission of HIV: a review of scientific, program, and policy advances for sub-Saharan Africa. Curr HIV/AIDS Rep. 2013 Jun;10(2):124-33. doi: 10.1007/s11904-013-0154-z.
- Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.
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)
2016년 1월 1일
기본 완료 (실제)
2020년 1월 1일
연구 완료 (실제)
2020년 11월 1일
연구 등록 날짜
최초 제출
2017년 3월 21일
QC 기준을 충족하는 최초 제출
2017년 6월 23일
처음 게시됨 (실제)
2017년 6월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 5월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 5월 17일
마지막으로 확인됨
2022년 5월 1일
추가 정보
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. .
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