2. CONTENTS
Background – why this is a critical research problem?
Research question (s) / issue
Aim of the research
Study design
a. Description of intervention
b.Phases of intervention
c.Pre-intervention / preparatory phase (scoping / baseline
studies, capacity building, SA, etc.)
d.Implementation phase – Methodology
e.Evaluation phase – indicators and monitoring framework
Expected outcome (Theory of Change)
Ethical issues
Timeline
3. 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.
4. 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
5. THE ISSUE
27 million pregnancies per year*
0.7%
prevalence**
1,89,000 infected pregnancies per year
30% transmission
Cohort of 56,700 infected newborns per
year
*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
6. RESEARCH QUESTION
How effective is Milk Bank in reducing mother to
child HIV transmission due to breastfeeding in the
state of Andhra Pradesh?
7. 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.
8. OBJECTIVES
GENERAL OBJECTIVES
To 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.
10. 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
11. 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.
12. TI - PMTCT
Incentives-
Referrals donors Storage
mothers
Screening
and
Donors Processing Distribution
milk
Recipient-
Screenin non-
Collection
g infected
children
13. 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
14. PHASE IV: Pilot testing of intervention- feasibility
study, scalability study, reliability study
PHASE 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.
15. PRE - INTERVENTION
PHASE 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.
16. 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
17. STAKEHOLDER MAPPING
KEEP SATISFIED
HIGH MANAGE CLOSELY
POWE
R MONITOR KEEP INFORMED
LO
W LO HIGH
INTREST
W
18. 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 Data collection tools
TEAM
19. 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
20. Children with HIV
infected mothers
Randomization
Receive infected
Received donated
mother’s bottled
bottled milk
milk
Non
Disease Non Disease
Disease
d Diseased d
d
21. 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
22. 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.
23. ETHICAL CONSIDERATIONS
Pasteurizedhuman 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
24. TIMELINE
Our project will take 6 months for completion
27. Activity Week Week Week Week Week Week Week
1-2 3-4 5-6 6-7 7-8 9-10 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
Notas do Editor
A collateral benefit could be that donor milk banks may heighten breastfeeding awareness in the community at large