WET NURSING - A NOVEL DRUG TO

REDUCE PMTCT

GROUP- 4

CONTENTS Background – why this is a critical research problem? Research question (s) / issue Aim of the research Study design

a. Description of interventionb.Phases of intervention c.Pre-intervention / preparatory phase (scoping /

baseline studies, capacity building, SA, etc.)d.Implementation phase – Methodologye.Evaluation phase – indicators and monitoring

framework Expected outcome (Theory of Change) Ethical issues Timeline

BACKGROUND

Mother-to-child transmission - Transmission of HIV from an HIV-positive mother to her child during pregnancy, labor, delivery or breastfeeding

Without treatment, around 15-30 percent of babies born to HIV-infected women will become infected with HIV during pregnancy and delivery. A further 5-20 percent will become infected through breastfeeding.

BACKGROUND For most babies, breastfeeding is without question the best way to

be fed, but unfortunately breastfeeding can also transmit HIV. If no antiretroviral drugs are being taken, breastfeeding for two or more years can double the risk of the baby becoming infected to around 40 percent

Replacement feeding at the same time –INCREASES RISK OF DIARRHOEA.

As extended breastfeeding and mixed feeding is only safe when antiretroviral drugs are taken, there is now an emphasis on using antiretroviral drugs to prevent the baby becoming infected as well as an emphasis on breastfeeding..

But Nevirapine and lamivudine given to mothers are transmitted to infants via breastfeeding in quantities sufficient to have biologic effects on the virus; this may lead to an increased risk of a breastfed infant's development of resistance to maternal antiretrovirals and cause other ARV side effects

THE ISSUE

27 million pregnancies per year*

1,89,000 infected pregnancies per year

Cohort of 56,700 infected newborns per year

0.7% prevalence**

30% transmission

*Derived from population estimates (SRS) AND Crude Birth rate, adding 10% pregnancy wastage

**Weighted average of estimates numbers of rural and urban HIV prevalence amongst women15-19 years

RESEARCH QUESTION

How effective is Milk Bank in reducing mother to child HIV transmission due to breastfeeding in the state of Andhra Pradesh?

AIM

To reduce the prevalence of HIV transmission from mother to child due to breastfeeding from 5-20% to 0-1% by introducing human milk banking system.

OBJECTIVES

GENERAL OBJECTIVESTo compare the effect of donated bottled milk with infected mother’s

bottled milk in the state Andhra Pradesh

SPECIFIC OBJECTIVES To find out if mothers would feel comfortable with their child being

fed donated breast milk if they were unable to breast feed.

To find out if donor mothers would be comfortable to donate milk.

To find out various barriers attached to milk donation.

To assess that milk banking can reduce the risk of HIV transmission from mother to child.

To explore the scope of health voucher incentives in encouraging milk donation.

HYPOTHESIS

Donated milk will reduce the risk of transmission of HIV from mother to child.

HEALTH BELIEF MODEL

Perceived Susceptibility- emotional bond Perceived benefits- save an infants life Perceived Severity- chest congestion,

hardening of breasts, chances of breast cancer, purity of milk

Perceived barriers- cultural issues, psychosocial issues

Cues to threat- incentives

DESCRIPTION OF INTERVENTION Breastfeeding is the normal way to feed infants by

providing them with adequate amount of nutrients that they need for healthy growth and development.

But in case if mothers are infected from HIV infection than the best possible solution to deal with this is to provide them milk through Human Milk Banking System (wet nursing).

Encouraging more and more donors to be part of this intervention by giving them health voucher incentives.

This intervention would play a major role in reducing the risk of transmitting HIV infection from mother to child and would lead to safe and secure child bearing.

TI - PMTCT

Referrals

Donors

Screening Collection

Screening and

Processing milk

Incentives- donors

mothersStorage

Distribution

Recipient- non- infected

children

PRE - INTERVENTION

PHASE I: Base line Survey- Focus Group Discussion with donor mothers and receivers

PHASE II: Selection of donor/funding agencies PHASE III: Promotion through IEC Material among

the Donor mothers through SBA/TBA /ASHA/ANM/DOCTORS Referrals

Pre-testing of IEC Material for both

PHASE IV: Giving them details about the incentives i.e.

cash incentive of Rs. 500 for each bottle giving a kit for their new born child dry ration card with fenugreek seeds

PHASE IV: Pilot testing of intervention- feasibility study, scalability study, reliability studyPHASE V:Informed Consent from the donor mothers and ethical consent from IRB PHASE V: Initial screening of donor mothers

to donate excess breast milk and ensure that donor mother is not suffering from any of the communicable diseases

PHASE VII: Medical confirmation form quality of product ensuring through the medical

provider of donor mother and her infant's pediatrician

 a confirmation form from doctor ensuring that both mother and baby are healthy and mother can donate her excess milk.

PRE - INTERVENTIONPHASE VIII: Donor Testing

Donor Test Kit will be posted at their homes (free of cost) contain blood testing instrument and DNA screening Screening blood test DNA in the milk will be matched with the DNA identity profile make sure that milk donor is the same who are being screened if they are donating through different medium of transport.

STAKEHOLDERS Donor and receiver mother and their

families Child birth Educator, Nursing mother group Local TI- NGOs and CBOs Health Care Providers: social worker, nurses,

nursing assistant doctors International Donors/Agencies ( USAID,

World Bank, UNITAID, PEPFAR) Media Professionals Policy Makers Business/Finance Professionals State Medical Providers

STAKEHOLDER MAPPING

KEEP SATISFIED MANAGE CLOSELY

MONITOR KEEP INFORMED

HIGH

LOW LO

W

HIGH

POWER

INTREST

CAPACITY BUILDING

PERSONNELS METHOD

PEER EDUCATOR Demonstration, Manuals

DOCTORS Workshop

OUT-REACH WORKERS Demonstration, Manuals

CHILD BIRTH EDUCATOR Training Workshop

PROGRAM OFFICERS Training Workshop, Management Workshop

COUNCELLORS Workshop

MONITORING AND EVALUATION TEAM

Data collection tools

IMPLEMENTATION PHASE Study Area: Andhra Pradesh Study design: Randomized Control Trial Sampling method: Cluster Sampling Method Sampling Size: Two groups would be selected

randomly from the targeted population i.e. children with HIV infected mothers and they are randomly divided into experimental and non- experimental group.

one group of children would be given donated milk and others would be receiving infected mothers bottled milk

Children with HIV infected

mothers

Randomization

Receive infected mother’s

bottled milk

Received donated

bottled milk

Diseased

Non Disease

d

Diseased

Non Diseas

ed

MONTHLY MONITROING AND EVALUATION PHASE

S.No Materials Number

1. Number of IEC Material Distributed

2. Number of donor mother’s milk screened

3. Number of mother’s milk received from other sources

3. Number of donated milk distributed

4. Number of vouchers provided

5. Number of milk bottle to be met by our project

EXPECTED OUTCOME

Reduction in HIV transmission from mother to child from 5-20% to 1%

Awareness about importance of breast-feeding among the mass population.

ETHICAL CONSIDERATIONS

Pasteurized human donor breast milk will only be prescribed following written informed consent from a parent or guardian.

Privacy and confidentiality Precaution and risk minimization Professional competence Totality of responsibility; and

compliance with ethical concerns

TIMELINE

Our project will take 6 months for completion

THANK YOU…

Activity Week 1-2

Week 3-4

Week 5-6

Week 6-7

Week 7-8

Week 9-10

Week 11-12

Review of literature

Selection of staff and investigators

Study plan

Listing & purchasing of materials

Formulation , pretesting & finalization of tools

Training of investigators

Data collection

Analysis plan

Data entry and cleaning of data

Data analysis

Report publishing