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Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)

2022年5月17日 更新者: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.

研究概览

地位

完全的

详细说明

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.

研究类型

介入性

注册 (实际的)

412

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Western Cape
      • Cape Town、Western Cape、南非、7750
        • Gugulethu Community Health Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
无干预: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.
实验性的: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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Viral suppression
大体时间:24 months
Time to viral load >1000 copies per ml
24 months

次要结果测量

结果测量
措施说明
大体时间
Maternal retention in care
大体时间:24 months
Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
24 months
Maternal death
大体时间:24 months
Maternal deaths over the study period
24 months
Maternal mental health
大体时间:24 months
Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
24 months
Maternal health care service use
大体时间:24 months
Use of health facilities including hospitalization
24 months
Infant death
大体时间:24 months
Infant deaths over the study period
24 months
Infant health care service use
大体时间:24 months
Use of health facilities including hospitalization
24 months
Infant HIV testing
大体时间:24 months
Uptake of routine infant HIV testing
24 months
Infant HIV infection
大体时间:24 months
Mother-to-child transmission of HIV
24 months
Infant feeding
大体时间:24 months
Breastfeeding practices
24 months
Cost and cost-effectiveness
大体时间:24 months
Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
24 months
Acceptability of each ART service
大体时间:24 months
Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
24 months
Viral suppression at other cutpoints (>400 copies/mL)
大体时间:24 months
Time to VL >400 copies/mL
24 months
Viral suppression at other cutpoints (>50 copies/mL)
大体时间:24 months
Time to VL >50 copies/mL
24 months
Virologic Failure
大体时间:24 months
Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)
24 months
Combined retention/VL outcome
大体时间:24 months
Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)
24 months
Viral suppression at each study visit
大体时间:24 months
VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Landon Myer, MBChB PhD、University of Cape Town

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年1月1日

初级完成 (实际的)

2020年1月1日

研究完成 (实际的)

2020年11月1日

研究注册日期

首次提交

2017年3月21日

首先提交符合 QC 标准的

2017年6月23日

首次发布 (实际的)

2017年6月27日

研究记录更新

最后更新发布 (实际的)

2022年5月18日

上次提交的符合 QC 标准的更新

2022年5月17日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 195/2015

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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