Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women
2022年5月17日 更新者：Professor Landon Myer、University of Cape Town
Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women: A Pilot Study
Young pregnant and postpartum women living with HIV are at the greatest risk of disengagement from HIV services and suboptimal adherence to antiretroviral therapy (ART).
Among young women, stigma is a major barrier to retention in services and adherence to ART, and interventions are needed to combat stigma and improve ART outcomes.
The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in this population.
研究概览
详细说明
Despite major reductions in mother-to-child HIV transmission (MTCT), young pregnant and postpartum women living with HIV remain a vulnerable group and experience the greatest risk of disengagement from services and suboptimal adherence to antiretroviral therapy (ART).
HIV-related and intersectional stigmas are major barriers to uptake and retention in prevention of mother-to-child transmission (PMTCT) services and drive suboptimal adherence, and young women experience unique stigmas.
Despite this, there are no evidence-based interventions to combat stigma and improve ART outcomes in this group.
Peer support group interventions have shown promise in other populations, but have not been examined in young pregnant and postpartum women living with HIV.
The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in young pregnant and postpartum women living with HIV in South Africa.
Participants will be allocated to the standard of care, in which no standardized peer support groups exist for this patient population, or to a peer support intervention.
研究类型
介入性
注册 (实际的)
120
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
-
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Western Cape
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Cape Town、Western Cape、南非、7750
- Gugulethu Community Health Centre
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-
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
16年 至 24年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Aged 16-24 years
- Documented HIV infection
- Confirmed pregnant or recently postpartum
- Accessing antenatal or immediate postpartum PMTCT services at the study site
- Planning on remaining a resident of Cape Town for at least 6 months after enrolment
- Able to provide informed consent for research
Exclusion Criteria:
- Significant pre-existing psychiatric comorbidity that may impact ability to consent
- Stated intention to move outside of Cape Town during the 6 months after enrolment
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：支持治疗
- 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 |
|---|---|
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无干预：Local standard of care
Women receive integrated antenatal and HIV services during pregnancy and are referred to general adult HIV services after delivery; no standardized peer support groups exist for this patient population.
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实验性的：Peer support intervention
Women will be invited to attend monthly peer support groups during pregnancy and postpartum, separate from any routine health services.
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Peer support groups will meet monthly for the duration of follow-up, with separate groups for pregnant and postpartum women.
Groups will be facilitated by women who are living with HIV and have experience of PMTCT services in this setting.
Group sessions will include brief information and a structured discussion about a relevant topic, followed by opportunities for unstructured discussion.
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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 |
|---|---|---|
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Retention and viral suppression
大体时间：After 6 months of follow-up
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Combined endpoint of (i) retention in HIV services and (ii) HIV viral suppression.
Women will be considered to have achieved the primary outcome if they are both retained in care and virally suppressed.
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After 6 months of follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Psychosocial outcomes
大体时间：6 months
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Psychosocial outcomes, including perceived social support and adherence self-efficacy, assessed using self-report questionnaires
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6 months
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Implementation of the intervention
大体时间：6 months
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Implementation of the peer support intervention including standardization, assessed using logs and process notes completed by counsellors who will deliver the intervention
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6 months
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Acceptability of the intervention
大体时间：6 months
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Acceptability of the peer support intervention, assessed as utilization and during in-depth interviews in a subset of participants
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6 months
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Health status
大体时间：6 months
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Maternal and infant health status, assessed using self-report and routine medical records
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6 months
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Health service use
大体时间：6 months
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Maternal and infant routine medical service use, assessed using self-report and routine medical records
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6 months
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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。
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)
2019年8月30日
初级完成 (实际的)
2020年8月1日
研究完成 (实际的)
2021年11月1日
研究注册日期
首次提交
2019年7月16日
首先提交符合 QC 标准的
2019年7月25日
首次发布 (实际的)
2019年7月30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
其他研究编号
- 267/2019
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.