The CLIP Feasibility Study has been designed to explore prevailing facilitators and barriers for the upcoming implementation of the CLIP cRCT. This study aims to show the feasibility of conducting the CLIP cRCT in selected sites.
The objectives of the Feasibility Study are to:
1. Determine stakeholder support
2. Determine health care system organisation and infrastructure capacity
3. Determine cultural and community beliefs/practices/influences/attitudes
4. Determine the potential for scale-up and task-shifting for cHCPs administration of:
- patient and family education with a focus on pre-eclampsia/eclampsia knowledge particularly symptoms and signs as well as birth preparedness and complication readiness
- oral antihypertensive agent, as indicated
- parenteral drugs, as indicated
5. Assess cHCP competency and resource/informational capacity for provider training and develop appropriate training package
6. Pilot test the education and intervention package for acceptability and barriers identification
7. Identify/develop data collection tools for community and facility surveillance assessments in both the intervention and control clusters, develop a database, and obtain pre-intervention cluster level data for:
- maternal demographics
- maternal mortality & morbidity
- fetal mortality & morbidity
- neonatal mortality & morbidity
- pre-eclampsia/eclampsia prevalence and associated morbidities/near-misses
- current intervention coverage for women with pre-eclampsia/eclampsia including monitoring, antihypertensive agent, MgSO4, corticosteroids, and timely delivery.
8. Identify potential barriers to project success and commitments to remedy identified barriers
9. Conduct a cost identification analysis to conduct the Pilot CLIP cRCT and an adequately-powered Definitive CLIP cRCT
Multiple methods of data collection will be employed to explore enabling and disabling factors for the CLIP Trial in Nigeria, Mozambique, Pakistan, and India. Qualitative data will be collected through focus group discussions and in-depth interviews with diverse groups of community members, care providers, and policy makers. In addition, document review and participatory observations will be conducted. Quantitative data will be collected through health facility assessment, self-administered questionnaires and community surveillance.
Focus Group Discussions
Community perspectives will be obtained through focus group discussions by women of reproductive age represented by pregnant women and mothers with children under five, opinion leaders represented by religious leaders and elders, and male and female decision makers including family members particularly mothers-in-law. In addition, a variety of other health care providers will be included in focus group discussions due to their key role in health care service delivery: medical officers, obstetricians, faith-based providers, and traditional birth attendants.
Key policy makers will be targeted for in-depth interviews, these include: local opinion leaders, administrative heads, and hospital administrators. Health care providers who will participate include those in the formal (public and private) health care system as well as traditional birth attendants.
A systematic review of community health worker training curriculum will be conducted in all countries to determine their scope of responsibility. All relevant documents will be assessed in relation to the planned CLIP activities: community engagement, home visits, and domiciliary administration of intramuscular injections and oral medication in pregnancy.
Participatory observations will be conducted concurrent with all focus group discussions. At this time, one researcher is designated to observe and record field notes. In addition, a structured participatory observation was employed in Nigeria during a full antenatal day in four primary health centres.
Facility assessments will be used in the Feasibility Study to map facility locations, costs, available resources and services. Both public and private institutions will be evaluated in this process to gain insight to health care services in the region.
Self-administered surveys will be used to evaluate current knowledge, skills and readiness of community health care providers before the CLIP cRCT.
This surveillance activity will focus on past obstetric and general medical history for women of reproductive age over the previous 12 month period in Nigeria, Mozambique and Pakistan, as well as household socio-demographic information. In India, this data will be collected prospectively over a 5-month period. The primary objective of this data collection is to establish disease rates in the study communities to accurately assess the burden of disease and ultimate effectiveness of the intervention. Secondly, the community surveillance will serve to confirm the epidemiology of disease progression and presentation in target regions. Moreover, it will enable researchers to beta-test the surveillance processes prior to the trial.