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临床试验/NCT02005835
NCT02005835Unknown不适用

Improving Uptake and Retention in PMTCT Services Through Novel Approaches in Family Supported Care and in Community Peer Outreach Support in Malawi

Lighthouse Trust1 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,050
试验地点
1
主要终点
Retention in Care

研究概览

简要总结

The purpose of this study is to determine if enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.

详细描述

The Malawi Ministry of Health (MoH) has embarked on a novel and ambitious programme to prevent mother to child transmission of HIV (PMTCT) known as "Option B Plus". This programme takes a public health approach to promote maternal health and eliminate paediatric HIV infections through a "test and treat" model, offering all HIV-infected pregnant and breastfeeding women lifelong ART regardless of CD4 count or clinical stage. The overall goal is to improve ART uptake and retention, and thus outcomes, of HIV-infected pregnant women and their infants in the continuum of ART services.

Although the Option B Plus strategy offers an attractive rapid ART scale-up alternative to the WHO PMTCT recommendations and has the potential to profoundly impact maternal and infant outcomes, it has not been implemented in any programme setting. Operational challenges throughout the cascade of PMTCT services may affect the uptake and adherence to highly active ART treatment (HAART) by pregnant women, the follow-up of HIV-exposed infants and the long-term retention of this patient population. Several issues identified at the national level are potential threats to the successful implementation and scale up of Option B plus: a) potential suboptimal uptake of HAART by asymptomatic pregnant women due to low treatment literacy and stigma; b) low adherence to HAART and poor follow-up of HIV exposed infants; and c) lack of psycho-social support for long term retention in this relatively asymptomatic patient population (Schouten et al. 2011).

The aim of the overall project (4 years) is to evaluate facility-based and community-based support models to strengthen uptake and retention of mothers and families in PMTCT care in Malawi. Our hypothesis is that enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.

We will conduct a cluster randomized clinical trial evaluating three support models for the implementation of the Option B+ program. Each of the 21 clinics will be randomized to one of the three adherence and support strategies. Arm 1 is the standard of care arm as outlined by the Ministry of Health, Arm 2 is facility level support by a peer educator and Arm 3 is community level support by a peer educator.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV infected women Presenting for Antenatal Care, Labor&Delivery, or post-partum Infants of Enrolled mothers Husbands/Spouses of Enrolled mothers

排除标准

  • 未提供

研究组 & 干预措施

Facility-based Peer Support

Other

Facility-based Peer Support to provide the following at the clinic

  • Routine standard clinical care based on the MoH guidelines
  • Mentor mothers provide education and psychosocial support at facility
  • Weekly support groups provided in clinic
  • Phone call, SMS, or home visit for each missed appointment

干预措施: Facility-based Peer Support (Other)

Community-based Peer Support

Other

Community-based Support from Peer Mothers (Expert mothers):

  • Routine standard clinical care based on the MoH guidelines
  • Mentor mothers provide education and psychosocial support in community prior to each visit
  • Monthly support groups in community
  • Home visits for each missed appointment

干预措施: Community based peer support (Other)

Standard of Care

No Intervention

The Standard of care as outlined in the Malawi HIV integrated Care Guidelines

结局指标

主要结局

Retention in Care

时间窗: 12 months post ART initiation

The primary outcome is the proportion of women retained alive and on ART at 12 months post ART initiation.

次要结局

  • HIV free survival(6 weeks, 12 months, 24 months)
  • Retention at 24 months(24 months post ART initiation)
  • Child HIV status(6 weeks, 12 months, 24 months)
  • Infant HIV resistance(6 weeks, 12 months, 24 months)
  • Social outcomes(12, 24 months)
  • Family retention(12 months)
  • Maternal Viral Load(6 months and 2 years post ART initiation)
  • Maternal resistance(6 months, 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sam Phiri, PhD, MSc, DCM

Executive Director

Lighthouse Trust

研究点 (1)

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