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

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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

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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