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Objective 3: CLIP Trials Updates (December 2016 - January 2017)

The CLIP Trial has recruited a total of 76,945 pregnancies to date, and two of the three trials have ended the active phase of the recruitment.

It gives us great excitement to share that the CLIP Pakistan Trial has ended the active phase of the trial as of 31 December 2016. The CLIP Pakistan Trial, co-ordinated by Aga Khan University (AKU) in Karachi and led by Rahat Qureshi and Zulfiqar Bhutta was the largest of the CLIP Trials having enrolled 39,475* women. We congratulate the team at AKU for their efforts in recruitment, management of the largest of the CLIP Trials, and the Lady Health Workers (LHW) for having completed close to 59,000* antenatal and postnatal visits guided by PIERS On the Move (POM).

In the definitive trial, the LHWs transitioned to measuring oxygen saturation using pulse oximetry and demonstrated increasing proficiency during the life of the trial. We hope to provide empirical evidence on the ability of the LHW to deliver the complex CLIP intervention.  A site visit was conducted by Beth Payne in January to discuss concurrent projects and plans for analyses of the CLIP Pakistan Trial. We thank the AKU team for their hospitality, and for organising all the logistics related to this visit.

The CLIP India Trial ended its active recruitment phase on 31 October 2016 with a total of 19,007 women, and 63,000* POM guided antenatal and postnatal visits. The team is focussed on outcome adjudication, and data query and cleaning. Concurrently, a preliminary analysis is underway, and a site visit is being planned for late March to review the findings with the study team. Data collection for economic analysis was completed in over 40 private health facilities in Belgaum and Bagalkot, and the cost allocation exercise was undertaken at two public health facilities (i.e, Belgaum Institute of Medical Sciences, and CHC Sankeshwar). The field team has obtained costs related to accredited social health activists and auxiliary nurse midwives programmes (such as salaries, transport and training support) during the implementation of the CLIP Trial. We are happy to share that the results from the baseline study have been published in PloS One and can be accessed here: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0166623  

The CLIP Mozambique Trial has recruited 18,013* women and recruitment is scheduled to end 24 February 2017. There have been 31,105 completed POM visits; the majority (~72%) are antepartum visits. More than 2,782 community engagement sessions have taken place since the beginning of the trial. Community engagement activities have evolved to address questions and comments raised by participants. This community engagement information has been summarized and a total of 2,000 copies of the second edition of the booklet have been reproduced and distributed to the mobilizers, community health workers, nurses, activists, field workers, supervisors, community leaders, religious leaders and teachers within the CLIP intervention clusters. The transport scheme, a community fund to address the lack of transport resulting in delays in accessing emergency obstetric care, has been used by eight women to date and has been adopted by nine communities. The start-up fund was based on the predicted number of obstetric emergencies in the area and was provided by the CLIP study; however, the communities contribute and manage the fund to sustain the scheme after the trial. A site visit is being planned for February to monitor study progress, and plan for trial close-out.

As we progress towards closure of the active phase of the CLIP Trial, this exciting period is marked by a shift from delivery of the intervention to rigorous data cleaning in all the trial sites. The country teams’ are now also focused on completing adjudication of outcomes reported. This country-specific mechanism of physician review of every maternal and neonatal mortality and morbidity reported in the data is made more remarkable given the volume of data collected. We applaud the sites for their diligence and efforts.

*not final numbers