UPDATE (February 22nd 2016)
The CLIP Trial (Community Level Interventions for Pre-eclampsia) was initiated in Ogun State, Nigeria on February 2012 with a 12-month Feasibility study to identify barriers and facilitators to the proposed Trial. A Pilot study commenced April 2014 in four Local Government Areas (LGAs) of the State and the Definitive Trial commenced in ten LGAs April 2015.
Logistical challenges in data collection and data entry led to considerable deliberations of the local research team, the CLIP Steering Committee, the PRE-EMPT Technical Advisory Group, and the Data Safety and Monitoring Board. Recognising these challenges, the difficult decision has been taken to close the Trial on 31 January 2016.
In order to maintain the integrity of the wider CLIP project, and by mutual consent, it is planned that the focus now will be on a process evaluation of the CLIP intervention in Nigeria. This will entail studying community engagement and the CLIP visits in which the Community Health Extension Workers and Health Assistants use the PIERS on the Move (POM) device to guide the triage, treatment, and transport of hypertensive pregnant women. Important data related to the mobile health-supported task-shifting and levels of community support for community-level interventions will follow. The findings will inform policy decision-making. Data from three remaining trials in Mozambique, Pakistan, and India will determine whether there is a casual relationship between the CLIP intervention and an improvement in health outcomes.
The local CLIP team in Nigeria and the PRE-EMPT Team (CLIP Co-ordinating team based at St. George’s, University of London and the University of British Columbia) are overseeing all transition activities, and the teams guarantee the confidentiality of all data for those who participated in CLIP. Importantly, efforts are underway to ensure that capacity-building activities undertaken in Nigeria during the CLIP Trial remain in-country.
The PRE-EMPT and CLIP Nigeria teams would like to acknowledge the efforts of those involved with CLIP in Nigeria over the past five years. In particular, we would like to recognise the generous support of Alhaji Olatunde Okewole (Chairman Ogun State Local Government Service Commission), Dr. Olaokun Soyinka (erstwhile Ogun State Honourable Commissioner of Health), members of the Ogun State Local Government Service Commission, the Medical Officers, Nurses/Midwives, the Community Health Extension Workers, and the Health Assistants for their service and commitment to the project. Most of all we are grateful to the women and their families for their participation and contribution to these activities.
Community mobilisation in Nigeria benefitted from significant support by local leaders, and galvanised patient advocacy efforts by bringing together survivors of pre-eclampsia and eclampsia in participant-led “Survivors’ Club.” It is our hope that the resilience and strength observed in these endeavours will translate into improved health outcomes for the mothers and babies in Ogun State, Nigeria.
The CLIP Feasibility Study in Nigeria is led by PIs: Olufemi Oladapo, Professor Olalekan Adetoro, Professor Kayode Dada, with further support from Bisi Orenuga, Bimpe Osiberu and David Akeju.
Data collection, entry and analysis for the CLIP Feasibility Study in Nigeria is complete. Data collection, cleaning and analysis were conducted by the local Nigerian team in close communication with the co-ordinating centre at UBC.
The findings of the Feasibility study highlight the key community factors, resources and infrastructure capacities which may influence the CLIP cRCT in Ogun State.
CLIP Pilot Trial
The CLIP Pilot Trial in Nigeria took place, between March 2014 to May 2015 in four pilot clusters: Yewa South, Remo north, Imeko-Afon and Sagamu. During this time, the CLIP Nigeria team also extended the baseline survey to the 6 remaining Definitive Trial clusters.Since March 2014 there have been more than 9941 pregnancies registered in the CLIP Pilot Trial and 5558 women have completed one or more CLIP study visits with a community health worker in an intervention cluster. The total number of CLIP visits completed is 8699.
Based on the data collected up to August 2015, the rate of hypertension is 4.29%. There have been 152 study visits resulting in a recommendation to seek higher level care; either within 4 or within 24 hours. The most frequent indication for urgent referral is severe hypertension, accounting for 26% of referral recommendations.