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临床试验/NCT04372667
NCT04372667已完成不适用

Adaptation and Evaluation of the PMTCT Community Score Card Approach in Dedza and Ntcheu Districts, Malawi

Elizabeth Glaser Pediatric AIDS Foundation1 个研究点 分布在 1 个国家目标入组 1,233 人开始时间: 2017年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,233
试验地点
1
主要终点
Early retention of newly diagnosed HIV-positive women in HIV care

研究概览

简要总结

This CDC-funded study sought to evaluate the effect of an adapted Community Score Card Approach on maternal retention in ART, maternal retention across the PMTCT service cascade, and the uptake of early infant diagnosis services in Malawi. The study also estimated the cost of the implementation of the Community Score Card Approach.

详细描述

Prevention of Mother to Child HIV Transmission (PMTCT) services aim to identify HIV-infected pregnant and breastfeeding mothers and initiate them on antiretroviral treatment (ART) for improving the health of the mother as well as reducing HIV transmission to their infants. In 2011, Malawi was the first country to adopt lifelong ART for HIV- pregnant and breastfeeding women, known as 'Option B+'. Despite leading the way on operationalization of this approach, Malawi has faced challenges retaining HIV-infected pregnant and breastfeeding women on lifelong ART as well as with improving uptake of early infant HIV testing for HIV-exposed infants. Innovative approaches are needed which engage health service users (i.e. patients) as part of quality improvement solutions within clinical settings to improve retention throughout the PMTCT cascade and ultimately improve PMTCT outcomes for mothers and infants.

One approach to broadly engage health service users in quality improvement activities is the Community Score Card (CSC). The CSC engages both service providers and users within a clinical setting in dialogues to identify solutions to the perceived barriers with health service delivery and utilization.

CARE developed the CSC intervention in Malawi in 2002 as part of a project aimed at developing innovative and sustainable models to improve general maternal and child health services. The main goal of the CSC intervention is to positively influence the quality, efficiency, and accountability with which health services are provided at different levels. The original CSC consists of five core phases, repeated on a regular basis (called "rounds"), for the life of the project.

This project adapted the CSC to the PMTCT setting across 11 sites in two priority PEPFAR scale-up districts in Malawi. The adaptation of the CSC was evaluated through a pre-post design to measure change in maternal retention on ART, change in maternal retention across the PMTCT service cascade, and uptake of Early Infant Diagnosis (EID) services following CSC implementation. Additionally, the project estimated the cost of the adapted CSC implementation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • New born infants of HIV-positive women
  • Women 18 years and over newly initiating antiretroviral therapy (ART) at ART clinic
  • HIV-positive pregnant women >15 years of age newly receiving care at first ANC (ANC1)
  • Women who are HIV-positive at ANC1 (known positive, already on treatment)
  • Women who are newly identified HIV-positive and initiated on treatment at ANC (newly identified at ANC or labor and delivery)
  • Women known HIV-positive but not yet on treatment prior to enrollment at ANC and initiated on treatment at ANC

排除标准

  • 未提供

研究组 & 干预措施

Post intervention

Experimental

Community score card approach

干预措施: Community score card approach (Behavioral)

结局指标

主要结局

Early retention of newly diagnosed HIV-positive women in HIV care

时间窗: 1 to 6 months

Proportions of HIV-positive women (pregnant and breastfeeding women as well as non-pregnant women) newly initiating ART services retained in HIV care

Early diagnosis of HIV exposed infants (HEI)

时间窗: 6 - 8 weeks after birth

Proportion of HEI receiving a DNA PCR test

Early retention of pregnant and breastfeeding HIV positive women in PMTCT

时间窗: 1 to 6 months

Proportions of HIV-positive pregnant and breastfeeding women (including women newly-identified and already-known to be HIV positive) retained in PMTCT services

Implementation cost of CSC

时间窗: 12 months

Estimate the total cost of implementing of the CSC intervention at community and facility levels.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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