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Introduction and Scale-Up
7.1% Chlorhexidine Digluconate for Umbilical Cord Care
April 12, 2016
Chlorhexidine Working Group (CWG)
An international collaboration of organizations dedicated to advancing the use
of 7.1% chlorhexidine digluconate (delivering 4% chlorhexidine) for umbilical
cord care through advocacy and technical assistance.
Members include individuals representing:
• PATH [CWG Secretariat]
• ayzh
• Bill & Melinda Gates Foundation
• Boston University
• Burnet Institute
• Centre for Infectious Disease Research in Zambia
• Clinton Health Access Initiative
• Drugfield Pharmaceuticals Ltd. (Nigeria)
• Duke University
• GSK (UK)
• Global Health Action
• Jhpiego
• John Snow, Inc.
• Johns Hopkins Bloomberg School of Public Health
• Johnson & Johnson (USA)
• Lomus Pharmaceuticals Pvt. Ltd. (Nepal)
• Maternal Child Survival Program
• PSI
• Promoting the Quality of Medicines/ United States
Pharmacopeia
• Save the Children/Saving Newborn Lives
• Systems for Improved Access to Pharmaceuticals and
Services/Management Sciences for Health
• United Nations Children’s Fund
• United States Agency for International Development
• Universal Corporation Ltd. (Kenya)
• University of Illinois at Chicago School of Nursing
• University Research Co., LLC | Center for Human Services
• World Health Organization
Coordinating global uptake The Chlorhexidine Working Group accelerates introduction and scale-
up of chlorhexidine for umbilical cord care by:
Coordinating efforts for global policy development (e.g., WHO EML and WHO cord care recommendation).
Managing clinical, technical, and program knowledge.
Ensuring rational decision making for resource allocation and priority setting.
Identifying and troubleshooting issues that arise.
Aligning demand with quality supply.
CWG Resource page on Healthy Newborn
Network (HNN) website
Materials for:
• Consensus building
• Building evidence for
implementation
• Aligning policies and guidelines
• Demand generation and training
• Manufacturing and distribution
• Monitoring and evaluation
http://www.healthynewbornnetwork.org/issue/chlorhexidine-
for-umbilical-cord-care/
Presenters
Mali: Winifred Mwebesa, MD, MPH
Senior Director, Family Planning/Reproductive Health,
Department of Global Health, Save the Children USA
Liberia: Marion Subah, MSN
Technical Director, Jhpiego/MCSP, Liberia
Kenya: Mutsumi Metzler, MBA
Senior Commercialization Officer, PATH
Nigeria: David Milestone, MBA, MPA, MS
Senior Market Access Advisor
Nikki Tyler, MBA
Market Access Advisor
Center for Accelerating Innovation and Impact, USAID
Every day. In times of crisis. For our future.
CORE Webinar – April 12, 2016
Dr. Winnie Mwebesa – Save the Children
Introducing Chlorhexidine for Cord Care in Mali
The Context in Mali • NMR: 35/1000 (Mali DHS 2012)
• Facility Births: 55% (Mali DHS 2012)
• Main causes of newborn deaths: infections (32%), prematurity
(29%), asphyxia (24%) (CHERG, 2010)
• Guidelines and standards recommend « not putting anything
on the cord »
• MCHIP 2014 endline survey conducted in Kita and Diema
districts: 87% of mothers reported the use of a non
recommended substance
• 2014 best practices workshop: session on global evidence on
CHX and results from the MCHIP endline: Recommendations
to introduce CHX
Formative Research Study
Overall Objective
Better understanding of the acceptability and
accessibility of Chlorhexidine digluconate 7,1%
for newborn cord care by communities and
providers
Specific Objectives
• Describe existing practices and perceptions
regarding newborn cord care
• Gauge the acceptability of Chlorhexidine
digluconate 7,1%
• Better understanding of the potential financial
and geographic access to CHX
• Collect input to inform the appropriate
mechanism for distributing and marketing/sales of
CHX to beneficiaries
9
Methodology Target population Total
Focus Group
Discussions
Mothers of Children 0- 59 months 4
Grandmothers – “mussokoroba” 6
Heads of Households 4
Individual
Interviews
1. CHW sites & satellite villages
Mothers of Children 0- 59 months 30
Trained TBAs 12
CHWs 6
Relais 8 /12
2. Health Facility sites: health centers &
district hospitals
Midwives/obstetric nurses/matrones 8
ASACOs (trios) 6
HC directors 6
Maternity doctors (D. Hosp) 2
DHOs 2
Study Results: Select Findings
• 60% (18/30) of mothers interviewed reported
having attended ANC
– 20% received counselling on cord care during ANC
• Providers don’t provide counseling on cord care
during ANC; mainly done after facility deliveries
• 57% of deliveries were conducted by TTBAs.
Their advice is respected by community
members (more frequent in Kenieba vss
Koutiala)
– Most TTBAs apply and advise mothers to use a
substance on the cord (10/12)
• CHWs and the relais are informed about
deliveries and make home visits to check on
newborns. Their advice on cord care is not
respected by mothers
Study Results: Select Findings
Substances used Reason for use
• Crushed shea butter nuts
(Koutiala) Help the stump fall off
• Lizard excrement powder
«bassa bo» or insect powder
mixed with shea butter, sap or
powder of Pourghère «Bagani
dji» (Koutiala)
Help the stump fall off and healing of the
umbilicus
• Crushed Néré nuts mixed with
shea butter, bottle shards
(Koutiala)
Help the umbilicus to heal
Most communities use various substances for « cord care » that differ from 1 district to another
• Shea Butter is the substance most commonly used in the 2 districts
Can Chlorhexidine be an alternative to current practices?
• Some/most communities perceive these practices as traditional and
« hard-to-abandon »
• All actors (providers and communities) are supportive of an
alternative to their current practices – i.e., Chlorhexidine - on
condition that the product be:
– Low cost, permanently available, with proven effectiveness
• Communities provided information on:
– Where: Dépôts, CHWs, relais, TTBAs, village chief or his advisors, women’s
groups, kiosks
– Cost: 100 à 250 CFAs (20-50 cents) – with a range from 25-2000 CFAs (5
cents to 4 dollars )
– Proposed names:
• «baratoulou» ou «batatoulou», - meaning a lotion/pommade for the cord
• «barafura» ou «batafura» - medication for the cord
What has been so far?
• Findings have guided the development of the introduction
process
– CHX gel is being introduced as a low-cost, available and effective
alternative for substances currently being used
– Communication strategy developed – with messages that explain why
CHX is a safe alternative and how/how long it should be used
– Training materials are being adapted for use in training providers and
community actors
– Duration – product to be applied for the first 7 days till cord stump
falls off; otherwise potential for reverting to other substances
– When/how to introduce the product: women will receive a
prescription during pregnancy; at the facility immediately after birth; or
procure it immediately after birth (community or facility)
– CHX will also be made available through social marketing –
USAID/KJK (JHU CCP lead)
What has been so far?
• A 2-year action plan (2015–2016) and technical brief
developed for the introduction of CHX - key steps:
– 4 districts selected for the introductory phase to inform programming
– An estimation exercise to identify needs for the first year
– Procurement from Drugfield, Nigeria: 20,000 tubes graciously donated
by the CHX working group
– An evaluation will be conducted for this first phase to inform further
scale up
Questions?
Made possible by USAID, Save the Children and the Mali Ministry of Health.
Joseph Kerkula, MD, Director Family Health Division, MOH, Liberia
Marion Subah, CNM, Technical Director, MCSP Liberia
Liberia has a newborn death rate of 26/1,000 live births which is among the highest in the world
Neonatal deaths account for 35% of under-five deaths with
prematurity, intra-partum related events, and infections as the major causes of deaths.
27% of all neonatal/newborn deaths in Liberia are due to newborn infection
61% of deliveries are done by a skilled provider; however, only 30% of the newborns actually receive any form of postnatal care by a skilled provider.
Poor hygiene and limited infection prevention and control (IPC) practices at birth and in the first week of life increase the risk of deadly but preventable infections.
Each Ethnic group has their own cord care beliefs and practices, which includes: o Alcohol to cord o Leaves- herbal
mixture o Talc powder o Ash o Dirt o Maggi cubes o Dressing cord o Leaving a binder
around the baby until cord drops
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February 2013:
◦ MOH discussion and adoption of chlorhexidine.
◦ Policy developed.
September 2013: Introduction Phase: pilot project in Bong, Montserrado and Margibi counties.
February 2014: external consultant recommendations in five key areas: sustainability, cost, procurement routes, ANC, M&E.
March 2014: Chlorhexidine expanded to 48 facilities.
Between April and August 2014: MCHIP, SC Liberia, UNICEF, and UNFPA supported expansion of use of chlorhexidine in 4 more (Maryland, Grand Gedeh, River Gee, and Grand Kru).
Next Steps- ◦ “Costed” scale-up & procurement
plans.
◦ Expansion through community means.
◦ Review of current status.
◦ Inclusion of a CHX indicator in HMIS.
◦ Support to national RH committee for coordination & monitoring.
August 2014 Ebola outbreak halted the distribution
Developed in 2013 Product Selected: ◦ 7.1% chlorhexidine digluconate
Why: ◦ Product sufficiently potent as an
antiseptic. ◦ May replace common, harmful
practices such as applying substances to the cord.
Delivery Strategies: ◦ All births: facility & home ◦ Multi-prong distribution
approach. public and private health
services. antenatal clinics & labour and
postpartum wards. community health workers. retail outlets .
Chlorhexidine will be applied to the cord for all births irrespective of where childbirth takes place - both institutional and home deliveries.
Using a multi-prong distribution approach. ◦ Through existing public and private health services.
◦ At antenatal clinics and in the labour wards.
◦ Through community health workers to reach women who delivered at home.
◦ Through retail outlets including pharmacies.
The MOHSW issued a policy to adopt the use of 7.1% chlorhexidine digluconate for all babies born in Liberia in May 2013.
7.1% chlorhexidine digluconate for umbilical cord care incorporated into Liberia’s reproductive health commodities list in Summer 2013.
Local name for product determined: Weniŋ-kɛɛ-sale meaning “naval string medicine”.
10 gm tubes of the chlorhexidine made and package specifically for Liberia.
PRIORITY INVESTMENTS
1. Quality Emergency Obstetric and Neonatal Care and routine AYF - RMNCAH Service Delivery
2. Emergency preparedness, surveillance and response, especially maternal neonatal deaths surveillance and response (MMNDSR)
3. Sustainable community engagement
4. Leadership, governance and management at all levels
Making plans to finalize scale up plan
Jan 26, 2016
Republic of Liberia
Reproductive, Maternal, Newborn, Child and Adolescent Health Investment Case Family Health Division Ministry of Health
Introducing 7.1% chlorhexidine gluconate (CHX) for umbilical cord care in Kenya
Mutsumi Metzler
Sr. Commercialization Officer
April 12, 2016
Five key activities
Page 29
Formulation of policy and guidelines
Establishment of local production
base
Market research
Initial implementation in Western and Nyanza regions
TA for a national scale-up strategy
development
Formulation of policy and guidelines
Collaborated with the Kenya Ministry of Health and other key stakeholders to: • Developed policy and guidelines for cord care. • Included chlorhexidine in the national essential medicine list. • Developed a training protocol for health workers. • Created behavior change materials targeting mothers.
Page 30
Formulation of policy
and guidelines
Establishment of local production
base
Market research
Initial implementation in Western and Nyanza regions
TA for national scale-up strategy
development
Policy alignment
• Gel and aqueous solution (Gel is being introduced). Product form
• Apply chlorhexidine once daily for 7 days or until the cord falls off, whichever occurs first.
Application regimen
• Home and facility births Location of
use
Page 4
Establishment of local production base
• Elicited interest from pharmaceutical manufacturers (October 2014).
• Performed rapid assessments of facilities and due diligence (November 2014).
• Performed in-depth GMP assessment and identified areas for improvement (April 2015).
Page 32
Abbreviation: GMP, good manufacturing practices.
Formulation of policy and guidelines
Establishment of local
production base
Market research
Initial implementation in
Western and Nyanza regions
TA for national scale-up strategy
development
• Regulatory approval of CHX gel
manufactured by a Kenyan
company (November 2015).
Market research
• Conducted market research in 2014 to identify effective distribution and communication strategies.
• Included 8 counties in 4 regions. • Samples size:
• Surveyed 738 mothers and family members. • Interviewed 80 service providers and
policymakers, held 8 focus groups with mothers.
Page 33
Formulation of policy and guidelines
Establishment of local production
base
Market research
Initial implementation in Western and Nyanza regions
TA for national scale-up strategy
development
Market research: major findings
• Receiving antenatal care and giving birth at government facilities were common.
• Health care professionals were the most trusted source of information.
• Willingness to use the CHX product was high.
• Effectiveness of the CHX product was a key reason to use it.
• There was no strong preference toward either gel or liquid form.
Page 34
Initial implementation in Western and Nyanza regions (Nov 2015–Sept 2016)
• Support Kenyan Ministry of Health’s effort to introduce and scale use of CHX.
• Introduce CHX gel (produced by a Kenyan manufacturer) initially in five counties in the Nyanza and Western regions, leveraging PATH’s APHIAplus project.
• Implemented a monitoring and evaluation plan and collect data to support development of a national scale-up strategy.
Page 35
Formulation policy and guidelines
Establishment of local production
base
Market research
Initial implementation in Western and Nyanza
regions
TA for national scale-up strategy
development
Service delivery model evaluated
1st ANC at RMNCH facilities
Receive the product and education
Subsequent ANC at RMNCH facilities
Confirm the receipt of the product. Provide product if it was not provided.
Reinforce the information on the CHX Product that was provided during the previous visit.
At time of childbirth
•Mothers bring the CHX Product that they received during the ANC.
•Apply the CHX Product immediately after the cord is cut.
•Give mothers instructions to continue to apply the product for 7 days (but stop application once the cord falls off).
At 1st CWC visit
•Confirm if the product was applied for 7 days and how much mothers adhere to the instructions.
• # of total births captured in the Maternity Register
• Application of CHX Product captured and source of the product captured by a data collection tool
ANC visit and receipt of the product captured in the ANC register
Level of user adherence captured by a data collection tool
ANC visit and receipt of the product captured in the ANC Register
Page 9
TA for a national scale-up strategy development
Page 37
Formulate policy and guidelines
Establishment of local production
base
Market research
Introduction in Western and
Nyanza regions
TA for to a national scale-
up strategy development
Dec 2015: the first strategy
meeting hosted by the Kenyan
MOH
Draft national scale-up strategy
is under development.
June 2016 (est): Second strategy
meeting + review of mid-term data from the initial
implementation.
Finalize the strategy and translate the strategy into
implementation plan.
Sept 2016 (est): finalize the
national scale-up strategy and
implementation plan.
Feb 2016: Disseminated policy and guideline to all counties to get support. Continue to involve counties in the process of
implementation strategy and plans.
Development of CHX scale-up strategy in Nigeria
CORE Webinar April 12, 2016
39
Nigeria has a large share of neonatal deaths, and ~60,000 deaths per year stem from infection
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Nigeria has the second highest burden of neonatal deaths globally, estimated at 276,000 annually
Countries with largest number of neonatal deaths Thousands of neonatal deaths, 2014
Given Nigeria’s high annual number of neonatal deaths, progress in reducing neonatal deaths globally is closely linked to results in Nigeria
These nine countries account for ~2/3 of
global neonatal deaths
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Annual neonatal deaths in Nigeria Thousands of neonatal deaths, 2013
Infection (includes sepsis, meningitis, and tetanus) is the third largest driver of neonatal
deaths in Nigeria
About 60,000 deaths are due to infection – and about 20,000 of these are umbilical cord-related
Source: N. Orobaton, et al., “A Report of At-Scale Distribution of Chlorhexidine Digluconate 7.1% Gel for Newborn Cord Care to 36,404 Newborns in Sokoto State, Nigeria: Initial Lessons Learned,” PLoS ONE 10(7), July 2015; World Bank; UNICEF, “Levels and Trends in Child Mortality,” 2014
40
In Nigeria, coverage of CHX remains low – although programs are gaining traction in a number of states
Source: TSHIP Final Dissemination Meeting, July 7, 2015; DHS 2013; PATH, “Market Research for 7.1% Chlorhexidine Digluconate: Nigeria,” Nov. 2014; Stakeholder interviews, Sep.- Nov. 2015
1% 3%
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10%
15%
20%
25%
30%
2012 2013 2015
Coverage of CHX in Bauchi and Sokoto
2012 - 2015
Bauchi
Sokoto
Over ~1,000 newborn lives were saved in these two states as a result of CHX in the past three years - other states,
such as Ogun, Kano, Kaduna, and Katsina, have also begun scaling CHX but coverage to date remains fairly low
Today’s national CHX coverage in Nigeria can largely be attributed to TSHIP’s work in Bauchi and Sokoto
Application of CHX is low today, with national coverage significantly under 5%
While CHX coverage is significantly under 5% nationally, market research indicates that ~90% of women apply some substance to the cord already, suggesting a significant opportunity to scale CHX by
encouraging its substitution for other products
31%
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13%
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7% 11% Oil
Methylated spirit
Toothpaste
Ash
Ointment/powder
Other
Recognizing the opportunity to build on these initial efforts, the FMoH developed a scale-up strategy and implementation plan to lead national scale-up efforts and overcome key barriers to widespread coverage
Use of various cord care products in Nigeria
2013
41
The development of the CHX scale-up strategy in late 2015 built on existing efforts in Nigeria
Source: James, Dr. Femi, “Introduction of 4% Chlorhexidine in Nigeria: Journey so far,” Sep. 2015; Stakeholder interviews, Sep.- Nov. 2015
2013
2012
2016
2014
Indigenous production of CHX commenced by Drugfield
CHX introduced in Kano, Kaduna, and Katsina via CHAI
CHX introduced in Bauchi and Sokoto via TSHIP
First stakeholder meeting convened by FMoH
Second and third stakeholder meetings convened by FMoH
CHX included in country implementation plan for UNCoLSC
Specifications for CHX in Nigeria articulated (25g tube of gel)
National CHX working group inaugurated
Nepal learning visit completed
Regulatory approval given to three indigenous manufacturers
CHX provisionally included in EML
2015 8+ states distributing CHX via community or facility systems
CHAI market research conducted
Sokoto study tour completed National Newborn Conference convened
University of Benin Teaching Hospital study on cord care practices completed
TSHIP Knowledge, Attitude, and Perceptions study completed
Manufacturing guide developed by NAFDAC
Training packages and pre-service curriculum materials updated
From September 2015 to December 2015, the draft scale-up strategy was developed
• September 2015: stakeholder’s meeting with 70+ in attendance; needs assessment conducted
• September 2015 to November 2015: series of 40+ interviews to pinpoint strategy and implementation recommendations
• November 2015: draft scale-up strategy presented to FMoH
• December 2015: second stakeholder’s meeting to present draft strategy and incorporate feedback
• March 2015: scale-up strategy to be presented at Newborn Sub-committee Meeting in Nigeria
42
The scale-up strategy consists of key interventions across five interrelated components of scale-up
• Generate demand across all target users and points of access
• Develop and disseminate key messages and trainings via multiple channels
• Improve communications to drive demand for CHX
Market & user understanding: generate awareness and demand
• Leverage existing private and public delivery channels in each state to integrate CHX with other products
• Advocate for state procurement
• Support current and future indigenous manufacturers to expand private sector distribution
• Incorporate branding and messaging recommendations
Manufacturing & distribution: increase availability of the product
• Maintain, and ensure, that favorable policies are in place
• Seek commitment from key opinion leaders to help activate target users
• Mobilize resources and support for scale-up
Policy, advocacy, & financing: strengthen enabling environment
• Monitor evidence from recent and future studies and address as needed
Clinical & regulatory: maintain existing support
• Formalize national coordinating mechanism
• Appoint an uptake coordinator to support execution of the strategy
• Establish and strengthen coordination in each state
• Track progress against targets
• Oversee strategic approach to roll-out
Coordination: ensure leadership needed to match supply and demand
Successful implementation of these interventions depends on commitment from many public and private stakeholders – as well as close coordination amongst them
43
To implement scale-up efforts, active involvement from public and private stakeholders are needed…
Source: Stakeholder interviews, Sep.- Nov. 2015; Dalberg analysis
The FMoH, with support from an uptake coordinator, will drive scale-up by coordinating across the numerous stakeholders and activities
Primary care facilities
Woman & child
Secondary care facilities
Tertiary care facilities
Indigenous manufacturers
Donors
Development banks
Federal government (including health and
regulatory MDAs)
Domestic private sector
Global private sector
Development partners
State government
Local government
Professional associations
International NGOs
FBOs, CSOs, Local NGOs
CHWs Pharmacies & PPMVs
LOCAL NATIONAL GLOBAL STATE
Distributors
44
…and these stakeholders were actively involved in the development of the scale-up strategy
Under the leadership of the FMoH, key partners involved in development and implementation of
the CHX scale-up strategy include*:
*List is not comprehensive
Source: James, Dr. Femi, “Introduction of 4% Chlorhexidine in Nigeria: Journey so far,” Sep. 2015; Stakeholder interviews, Sep.- Nov. 2015
• Given the decentralized nature of Nigeria’s government structure, partners provided insights and feedback based on relevant successes/failures in programming
• Under the leadership of the FMoH, the development of the scale-up strategy was truly collaborative – consultants provided assistance in interviewing and consolidating recommendations
• To make the strategy actionable, an implementation plan with a timeline, assigned roles and responsibilities, costing, and targets was developed
• Funding was also available to appoint an uptake coordinator – who will assist the FMoH in implementing and sequencing the recommended interventions; track progress; execute a strategic approach to roll-out across states; and troubleshoot as needed
45
The development of the scale-up strategy reinforced a series of lessons
To develop and implement the strategy, relationships are everything – significant coordination and collaboration are needed to earn buy-in
Craft the strategy so that immediate next steps are clearly defined… and encourage transition of implementation to those best suited
Know that you can’t do it all alone… and that all partners have strengths that can complement your limitations and constraints
Establish lines of communication that allow tough conversations on targets, budgets, and constraints
Ensure there are quick implementation ‘wins’ in the scale-up strategy to continue building momentum
Ensure continued momentum
Encourage open communication
Understand your limits and constraints
Remember the importance of advocacy
Build relationships
Focus on next steps
1
2
3
4
5
6
The goal is sustainability - all partners should feel ownership … and the plan needs to reflect an arc towards government ownership
While we are steeped in Chlorhexidine, remember that it is still relatively new to many – demand generation/awareness is key
Questions?
Patricia Coffey, PhD, MPH
Program Advisor, Devices and Tools Global Program
Group Leader, Health Technologies for Women and Children
PATH (Chlorhexidine Working Group Secretariat)
pcoffey@path.org
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