Malaria Control: Improving Health Outcomes for Mothers

and Children

CORE Group: Global Health Practitioner Conference April 17th, 2015

Session Objectives • Presentation Title: Prevention of Malaria in Pregnancy: Promoting IPTp-SP Early

in the Second Trimester

• Objectives: Define the WHO policy recommendation for use of IPTp-SP; describe determination of gestational age through history, lab test and physical exam, and discuss implications of the policy change at facility and community levels

• Presentation Title: Anemia: Trends, causes and programs to address it

• Objectives: Discuss trends in global anemia, major causes of anemia, and programs to reduce anemia

• Presentation Title: Integrated Community Case Management: Challenges and Successes in Diagnosis and Treatment of Malaria in the iCCM and IMCI Platforms

• Objective: Understanding of challenges related to the integration and

updating of several disease-specific guidelines for integrated case management

Presenters: Lisa Noguchi MCSP Senior Maternal Health Advisor, Jhpiego Rae Galloway MCSP Technical Lead in Nutrition, PATH Michel Pacqué MCSP Technical Lead in Child Health, JSI Jane Coleman MCSP Malaria Program Officer II, Jhpiego

Prevention of Malaria in Pregnancy: Promoting IPTp-SP Early in the Second Trimester

Update on WHO Policy Recommendations for IPTp-SP

Lisa Noguchi, CNM, PhD

on behalf of the Maternal Health Team

Objectives

At the end of this module learners will be able to do the following: • Define the WHO policy recommendation for

use of IPTp-SP • Describe determination of gestational age

through history, lab test and physical exam • Discuss implications of the policy change at

facility and community levels

Why is this an important topic? (1/2)

• WHO/AFRO recommended IPTp-SP (2004) • 1st, 2nd and 3rd dose in SSA is 64%, 38% and 23% respectively* • Far from universal coverage recommended by Roll Back

Malaria

• Negative consequences associated with malaria in pregnancy • Severe malaria, severe anaemia, pre-term delivery, maternal

death, and placental malaria • Linked to intrauterine growth restriction, stillbirth, and

delivery of low birth weight (LBW) infants**

*WHO. World Malaria Report 2013. Geneva: World Health Organization; 2013. **Aribodor DN, Nwaorgu OC, Eneanya CI, Okoli I, Etaga HO: Association of low birth weight and placental malarial infection in Nigeria. J Infect Dev Ctries 2009, 3:620–623.

Why is this an important topic? (2/2)

• Previous WHO guidelines recommended first dose of IPTp-SP at 16 weeks • Country guidelines often suggested quickening as

the “benchmark”

• Now need to re-educate MOHs, training systems, providers, and community decision-makers about importance of a dose as early as possible in the 2nd trimester

WHO Policy Recommendation for IPTp-SP (1/3)

• Starting as early as possible in second trimester, which begins at 13 weeks, IPTp-SP is recommended for all pregnant women at each scheduled antenatal care (ANC) visit until the time of delivery, provided that the doses are given at least one month apart

• SP should not be given during first trimester of pregnancy; however, last dose of IPTp-SP can be administered up to time of delivery without safety concerns

WHO Policy Recommendation for IPTp-SP (2/3)

• Should ideally be administered as directly observed therapy (DOT) • Three tablets sulfadoxine/pyrimethamine (each tablet

containing 500mg/25mg SP) • = Total required dosage of 1500mg/75mg SP

• Can be given on empty stomach or with food • Should not be administered to women

receiving cotrimoxazole prophylaxis due to higher risk of adverse events

WHO Policy Recommendation for IPTp-SP (3/3)

• WHO recommends administration of folic acid 0.4mg daily

• This dose may be safely used in conjunction with SP

• Folic acid at daily dose of 5mg or higher should not be given together with SP • Counteracts its efficacy as an

antimalarial

Side effects of IPTp-SP

• SP for IPTp generally very well tolerated

• Mild and transient side effects • N/V, weakness, dizziness

• Most side effects reported with first dose of SP • Tend to decrease with further

doses

• Should be discussed openly and managed in the ANC clinic

Implementation of the WHO Policy: Questions to Consider (1/2)

• What components of the WHO Policy may present challenges to implementation and scale-up? How can these be resolved?

• Provider/patient barriers, logistics, procurement, financing for additional doses

• What strategies can be developed to increase access to SP without increasing risks, e.g., administration in 1st trimester or inadvertent disclosure of HIV status (cotrimoxazole)?

• How can messages about IPTp be integrated into IEC about early initiation of ANC / ANC?

• What role can community health workers, communities, community leaders and other facilitators play in increasing uptake of IPTp?

• Which cadres are competent to determine if gestational age (GA) is less than 13 weeks and SP should not be administered?

• Which cadres should be authorized to administer IPTp? • Should some cadres have only limited authorization to

administer IPTp? • e.g., when easy to ascertain that pregnancy is NOT 1st trimester

• What strategies can be used to ensure that all providers are informed of the new policy on IPTp?

Implementation of the WHO Policy: Questions to Consider (2/2)

Determination of Gestational Age (GA) for 1st SP Dose in Pregnancy - History

• First day of last normal menstrual period (LNMP)

• Quickening - Primigravidas note quickening around

18 – 20 weeks - Multigravidas ~16 weeks (or earlier)

• Potential problems - LNMP may be uncertain - Breastfeeding and progestin-only

contraception (can have anovulatory vaginal bleeding/spotting)

- Quickening varies greatly among individuals

Determination of GA for 1st SP dose in pregnancy – Physical exam

• Assessment of GA needs to consider multiple data sources - Physical exam is just one component

• First trimester - Uterus grows from lemon to orange

size - Cannot be palpated abdominally

• Second trimester (13+ weeks) - Uterus is size of grapefruit and can be

palpated abdominally above symphysis pubis

NOTE: Pelvic (internal) exams are not necessary to determine uterine size in 2nd trimester, but may be needed for other care.

Determination of GA for 1st SP dose in pregnancy - Other

• Pregnancy tests, if available/affordable, can confirm pregnancy

• Symphysis-pubis fundal height (SFH) measurement - Generally only used after 20 - 24 weeks’ gestation

• Ultrasound - Can be superior to dating via LNMP or physical

examination, depending on clinical circumstances - However

• Dating precision decreases with gestational age • Controversial if all women should undergo U/S • Ultrasound machines not universally available

Determining Uterine Size and GA (1/3)

• At the beginning of the second trimester (13 weeks), the top of the uterus is usually just above the mother’s pubic bone (where her pubic hair begins)

• At about five months (20-22 weeks), the top of the uterus is usually right at the mother’s bellybutton (umbilicus or navel)

Determining Uterine Size and GA (2/3)

• To feel the uterus, make sure the mother has emptied her bladder

• Have the mother lie on her back with some support under her head and ask her to bend her knees, keeping feet flat on bed

• Explain to her what you are going to do (and why) before you examine her abdomen

• Your touch should be firm but gentle

Determining Uterine Size and GA (3/3)

• Place fingers on the pubic bone and walk them up the center of the abdomen until you feel the top of her uterus (fundus) under the skin. • It will feel like a hard ball • You can feel the top by curving your fingers gently

into the abdomen

• Uterus palpated a few fingerbreadths above the pubic bone is compatible with pregnancy in the second trimester

Client Counseling about IPTp-SP (1/2)

• Women are used to starting SP later in pregnancy • Counsel about importance of earlier dosing • Malaria parasites can attack in first trimester • If not cleared with SP, can affect placental development and

fetal growth early in pregnancy

• Women’s concerns must be addressed • Take SP with or without food • Folic acid 0.4 mg can be taken with SP • Not harmful to woman or baby • Can cause nausea, vomiting or dizziness, but short-lived

and subsides with further doses

Client Counseling about IPTp-SP (2/2)

• Pregnant women can receive SP at all scheduled ANC visits • Starting at 13 weeks • As long as doses are at least one month

apart

• Can be taken up to the time of delivery

Client Counseling about Iron/Folic Acid

• Iron and folic acid (IFA) tablets should be given to women at all ANC visits • Folic acid can be taken at the

same time as SP • WHO-recommended dose is

0.4mg • Pregnant women should not

receive a dose exceeding 5mg

Client Counseling about MIP

• Don’t forget to provide LLIN as early as possible in pregnancy, or let her know where she can obtain one!

• Advise return to facility for danger signs: fever, headache, N/V, fatigue, etc. • Can be signs of malaria • Must have diagnostic test for

malaria immediately and be treated if positive

Thank you!

• Acknowledgements • Patricia Gomez • Jane Coleman

Q&A

Trends in Maternal and Child Anemia and Control Programs

Presentation at the Core Group Conference, April 17, 2015

Rae Galloway Technical Team Lead for Nutrition

MCSP

Goals for the Presentation • Definition,

consequences, causes • Trends in anemia • Anemia control &

coverage of interventions

• Changes in anemia with at-scale implementation

• What are “at scale” implementation and program components?

What is Anemia?

• Low hemoglobin in the blood

• Hemoglobin is carried in the blood by red blood cells

• The function of hemoglobin is to carry oxygen from the lungs

Why is low hemoglobin a significant health problem?

Oxygen is needed by almost every cell in the

body to generate energy (ATP) to support body

functions and life

At the center of hemoglobin is iron (Fe)

which fixes oxygen in the lungs

What are the consequences of anemia (lack of oxygen or iron-dependent co-factors)?

• The early sign is fatigue • The worst case is

cardiovascular arrest and death

Others consequences: • Low productivity • Cognitive damage • Poor maternal and birth

outcomes-post partum hemorrhage, LBW

What are the causes of anemia?

• Direct causes • Decreased production of

Hb and RBCs (nutrition deficiencies), infectious diseases (malaria, TB)

• RBC destruction (malaria)

• RBC loss (helminths, bacterial infections, reproduction)

• Contributing causes • Lack of knowledge about

diet and lack of access to food with iron

• Environmental (lead) • Poor sanitation and

hygiene • Lack of access to

services (ANC and IPTp, trained birth attendants, bed nets)

WHO Guidance on Estimating the Public Health Significance of Anemia

Anemia Prevalence

≥40% 20-39.9% 5-19.9% 0-4.9%

Public Health Significance

Severe

Moderate Mild

Normal

What progress are we making in reducing anemia?

Changes in anemia in pregnant women have been slow with only 5 out of 10 regions attaining

more than a 5 percentage point change from 1995 to 2011

Regions with≤5 ppts change: • South Asia (53% to 52%)

• Central and West Africa (61% to 56%) • South Africa (34% to 31%)

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High Income, 1995: 23% High Income, 2011: 22% Central and Eastern Europe, 1995: 30% Central and Eastern Europe, 2011: 24% East and Southeast Asia, 1995: 34% East and Southeast Asia, 2011: 25% South Asia, 1995: 53% South Asia, 2011: 52% Central Asia, Middle East, and North Africa, 1995: 37% Central Asia, Middle East, and North Africa, 2011: 31% Central and West Africa, 1995: 61% Central and West Africa, 2011: 56% East Africa, 1995: 46% East Africa, 2011: 36% Southern Africa, 1995: 34% Southern Africa, 2011: 31% Andean and Central LAC and Caribbean, 1995: 37% Andean and Central LAC and Caribbean, 2011: 27% Southern and Tropical LAC, 1995: 43% Southern and Tropical LAC, 2011: 38%

Anemia in Children<5 years 1995 to 2011

The situation is even more alarming with a decrease in anemia of more than five percentage

points in only three regions--South Asia (12 ppts), Central & West Africa (9 ppts), and East

Africa (19 ppts)

In southern Africa anemia in children increased from 30% to 46%

How many African countries are tracking maternal and child anemia (DHS)?

• No surveys (7): Angola, Chad, Eritrea, Kenya (women), Namibia, Nigeria, Zambia

• One survey (10): Burundi, Cape Verde, DRC, Eq. Guinea, Kenya (MIS-children), Mozambique, Sao Tome & Principe, Senegal, Sierra Leone, Swaziland

• Two+ surveys (16): Benin, Burkina Faso, Cameroon, Congo (Brazzaville), Ethiopia, Ghana*, Guinea, Lesotho*, Madagascar, Malawi, Mali*, Niger, Rwanda, Tanzania, Uganda, Zimbabwe (*increase in anemia)

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What are the major anemia control interventions?

• Three major interventions

will address the greatest burden of the disease

• MIP (IPTp & ITNs)

• ITNs for children

• Nutrition improvement (dietary & iron-folic acid supplements)

• Deworming

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What are the trends in coverage of these interventions where severe anemia in pregnant women has decreased ≥80%?

Country Change in severe anemia

ITN/LLINs IPTp 90+ IFA Deworming

Madagascar 80% dec 50% any 46% ITN

48% any; 12% SP 8% 39%

Congo-Brazzaville 87% dec 64% any; 4% ITN 65% any drug; 16% l’amodiaquine 3% SP

2% NA

Malawi 89% dec 56% any; 50% LLIN

78% any; 77% SP

32% 27%

Rwanda 93% dec 73% any; 72% LLIN

NA 1% 39%

Uganda 100% dec 80% any; 71% LLIN

66% any; 63% SP 4% NA

38 PROGRESS APPEARS TO BE FROM INCREASED COVERAGE

OF MIP

Clearly more can & should be done to increase coverage of IFA with IPTp

A secondary analysis by Titaley, et al., 2010 of DHS from 19 malaria-endemic countries in sub-Saharan African countries found:

• The combined effect of IFA and IPTp decreased the risk of neonatal death by 24% (when women took≥90 IFA) and 18% (when women took <90 IFA)

• There was no significant protection from neonatal death with either IFA or IPTp alone

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IFA & IPTp need to be fully complementary: a word about getting the dose of folic acid right

• Folic acid is an essential nutrient for both humans and the malaria parasite

• Humans cannot synthesize folic acid; they obtain it from the diet or from supplements

• Pregnant women are given folic acid to meet increased needs in pregnancy NOT to prevent neural tube defects which form within 28 days after conception

• The malaria parasite obtains folic acid by de novo synthesis & salvaging folic acid from the host (humans) so giving too much folic acid helps malaria to thrive and multiply

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Giving folic acid ≥5 mg increases risk of treatment failure with SP in pregnant women (Ouma, et al., 2006)

Tx failure at 14 days with SP and different doses of folic acid (FA):

• Placebo: 13.9%

• 0.4 mg FA: 14.5%

• 5 mg FA: 27.1%

• There was no difference in mean Hb in either FA group

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As a result of this study, WHO recommends a dose of folic acid<5 mg

• This is not a problem in most countries which are giving a combined IFA supplement containing 60 mg of iron and 400 mcg folic acid

• Are some countries still giving the 5 mg dose of folic acid—yes!

• Countries should reduce stores of the 5 mg dose (which isn’t needed to meet folic acid requirements) & transition to the combined IFA supplement with the lower dose of folic acid

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How can we improve programs and obtain at-scale coverage?

• Get the dose & timing right (first trimester may be important for IFA to improve birth outcomes)

• Deliver and monitor the integrated package (IPTp and IFA; deworming?)

• Accurate forecasting & delivery of commodities

• Procure adequate numbers of IFA and SP based on estimated numbers of pregnant women, not past use

• Counseling messages on why and when to take

• Reach coverage of >80%

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What impact could these interventions have if they were scaled-up?

Selected effects from controlled studies:

• 38% decrease in severe anemia with IPTp

• 56% decrease in overall anemia with improved iron intake (IFA tablets; food) & decreased iron loss (deworming)

• 20-40% decrease in LBW with IPTp and 11-18% decrease in neonatal and 5-19% of infant deaths (pauci- to multi-gravidae)

• 18% decrease in LBW with improved iron status of mothers and 30-60% decrease in neonatal mortality when mothers take IFA early in pregnancy and for 6 months

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Thank You!

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Q&A

Integrated (Community) Case Management

Challenges and Successes in Diagnosis and Treatment of Malaria in the iCCM and IMCI

Platforms Michel Pacqué

Maternal and Child Survival Program

iCCM

• The good news • Global Fund New Funding Model

• Challenges • Fit into larger Health System/political ownership • Financing and sustainability • Technical “updates” – quality of care

Are technical updates a challenge to “assuring quality” of care.

Technical Updates and Quality of Care

Quality of care depends on how well national guidelines as well as health worker training and supervisory materials conform

to the most recent World Health Organization standards.

Quality Assessment of Diagnosis and Treatment of Malaria

Method: • To assess the level of adherence to WHO standards,

we collected training and supervisory materials for health workers in President’s Malaria Initiative (PMI) countries and appraised them for adherence to the standard WHO materials. Special attention was paid to training in and use of diagnostics like rapid diagnostic tests (RDTs) and assessment and management of severe febrile diseases.

Methods • Training and supervision materials voluntarily

provided by PMI countries • Training materials from 13 countries and

supervision tools from 7 countries were reviewed (out of the total 19 countries contacted).

Countries included COUNTRY IMCI and or Malaria Tools Supervision Tools 1 ANGOLA N N 2 BENIN Y (IMCI) N 3 DRC Y (IMCI/CCM – NMCP) Y 4 ETHIOPIA Y (IMCI/CCM – NMCP) Y 5 GHANA N N 6 GUINEA N N 7 KENYA Y (IMCI) N 8 LIBERIA N Y 9 MADAGASCAR Y (IMCI) N 10 MALAWI Y (IMCI) Y 11 MALI Y (IMCI) Y 12 MOZAMBIQUE* Y (IMCI – NMCP) Y 13 NIGERIA Y (IMCI) N 14 RWANDA Y (IMCI) Y 15 SENEGAL Y (IMCI) N 16 TANZANIA (Zanzibar) N Y 17 UGANDA Y (IMCI/CCM – NMCP) N 18 ZAMBIA Y (IMCI) N 19 ZIMBABWE Y (IMCI) N Total Received 14 8

Total Assessed 13 7

Methods • Desk review

• Tools compared with most updated IMCI algorithms • Incorporates diagnostic testing for malaria

• Particular attention to adherence to updated WHO guidelines on diagnostic testing and management of severe febrile illness

• Spreadsheet developed comparing specific steps in the algorithm with what is contained in country training and supervision materials

Questions not addressed by the study

• At the community level: • How are CHWs doing?

• How often are they correctly diagnosing and treating kids for malaria?

• What supply chain issues exist?

• How are CHWs trained? • How do they maintain skills?

• case load, supervision, etc.

Selected Findings

Classification of fever

• 12 countries defined fever correctly • Mali: Fever defined only as measured axillary temperature >38 degrees C

A child will be considered as “having fever” if:

The child has had any fever with the current illness The child feels hot The child has an axillary (underarm) temperature of 37.5°C (38°C rectal) or above

High fever is defined as a temperature of 38.5°C or above

Classification of fever

• 8 countries classified severe febrile illness in line with IMCI guidelines • Rwanda: Differentiates Severe Malaria from Very Severe Febrile Illness,

based on diagnostic test result

Severe febrile illness: Fever plus

Any general danger sign (unable to drink or breastfeed; vomits everything; convulsion(s); lethargic or unconscious)

And/or Stiff neck

Diagnostic Testing for Malaria

Nine countries have introduced diagnostic testing for malaria in their fever algorithms • Only four have instructions on how to perform an RDT

• Only two countries include instructions to perform an RDT when a child has been identified as having anemia

WHO Guidelines for Parasitological/laboratory diagnosis of malaria Prompt parasitological confirmation by microscopy, or RDT, is recommended in all patients suspected of malaria before treatment is started. Treatment solely on the basis of clinical suspicion should only be considered when a parasitological diagnosis is not accessible or will be delayed for more than two hours. However, patients with suspected severe malaria, and other high risk groups, should be treated immediately on clinical grounds.

Treatment of severe malaria

WHO recommendation: artesunate treatment for severe P. falciparum malaria in children Artesunate is preferred over quinine for the treatment of severe P. falciparum malaria in children. • Intravenous or intramuscular artesunate has been shown to

reduce significantly the risk of death from severe malaria compared to intravenous quinine. Intravenous artesunate is associated with a lower risk of hypoglycemia.

First-line drug for pre-referral treatment of severe febrile disease

IMCI guidelines Pre-referral treatments of choice: artesunate or quinine

Benin Artesunate suppository Democratic Republic of Congo Artesunate suppository

Ethiopia Artesunate suppository: Kenya Quinine or parenteral artesunate or artemether Madagascar Quinine Malawi Quinine

Mali IMCI: Quinine - NMCP: Artemether or Artesunate or quinine

Nigeria Quinine Rwanda Artemether Senegal Quinine Uganda Artesunate or Quinine or Artemether Zambia Quinine Zimbabwe Quinine

Management of Treatment Failure

• Eleven countries addressed treatment failure • Five have retesting with a RDT in the protocol • Another 5 countries use a clinical diagnosis to re-classify the child

If fever persists after 2 days, or child returns within 14 days: Do a full reassessment of the child. If any general danger signs or stiff neck: treat for VERY SEVERE FEBRILE DISEASE – and refer to hospital. If any cause of fever other than malaria: provide treatment for that cause. If the fever has been present for 7 days: refer for assessment. If there is no other apparent cause of fever: o For children who were classified as having malaria:

◦ Do microscopy. If parasites are present and the child has finished a full course of the first line antimalarial, give the second-line antimalarial, if available, or refer the child to a hospital. ◦ If you do not have a microscope to check for parasites, refer the child to a hospital.

DO NOT REPEAT the Rapid Diagnostic Test if it was positive on the initial visit

o For children who had fever and were classified as having no malaria: ◦ Repeat the malaria test. If a child has a positive malaria test, give first-line oral antimalarial. Advise the mother to return in 3 days if the fever persists.

Major findings

• In almost all countries assessed, there were one or more areas where training materials significantly deviated from the most recent WHO guidance

• In some countries, IMCI guidelines also deviated from national malaria treatment guidelines

• Some of the disparities may be because national policies were last updated before these new guidelines were issued

• Supervision tools appear to be available in only a minority of countries, raising the question whether standardized supervision checklists are used in some countries

• All countries should review and revise their guidelines and training materials, as appropriate, to ensure they align with the latest WHO guidance, and then on a regular basis thereafter

Questions for discussion

• What can NGOs do about “quality” as defined earlier

• What are the biggest challenges and how can NGOs with other partners approach them

Thank you!

Q&A

Key Take Aways

• Anemia is a prevalent and static public health problem in women and children

• Delivering IFA and IPTp-SP to 80% of pregnant women will improve maternal and newborn health and survival

• The dose of folic acid needs to be <5 mg to ensure the effectiveness of SP as an anti-malaria

• iCCM needs to be integrated to malaria and maternal child health program

• Updating guidelines, disseminating, and implementing is a stpe by step process

Take Aways

• Decreasing the risk of severe negative perinatal consequences from MIP requires initiation of IPTp-SP as early as possible in the 2nd trimester.

• A comprehensive approach to accurate estimation of gestational age is necessary for appropriate timing of IPTp-SP.

• Safely and effectively increasing uptake of appropriately timed IPTp-SP will entail the engagement of a broad group of stakeholders.

For more information, please visit www.mcsprogram.org

This presentation was made possible by the generous support of the American people through the United States Agency for International Development (USAID), under the terms of the Cooperative Agreement AID-OAA-A-14-00028. The contents are the responsibility of the authors and do not

necessarily reflect the views of USAID or the United States Government.

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