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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 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
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*
                      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
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 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.
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



                Incentives-
Referrals         donors        Storage
                  mothers




                Screening
                   and
Donors          Processing    Distribution
                   milk




                              Recipient-
Screenin                         non-
                Collection
   g                           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 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.
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.
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
HIGH                MANAGE CLOSELY




POWE
R MONITOR           KEEP INFORMED




LO
W     LO                             HIGH
                    INTREST
      W
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
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
  Received donated
                                           mother’s bottled
    bottled milk
                                                 milk



                                                         Non
Disease         Non                      Disease
                                                       Disease
   d          Diseased                      d
                                                          d
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
 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
TIMELINE
   Our project will take 6 months for completion
THANK YOU…
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

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Wet Nursing Novel Drug To Reduce Pmtct

  • 1. WET NURSING - A NOVEL DRUG TO REDUCE PMTCT GROUP- 4
  • 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.
  • 9. HYPOTHESIS Donated milk will reduce the risk of transmission of HIV from mother to child.
  • 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
  • 26.
  • 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

Notes de l'éditeur

  1. A collateral benefit could be that donor milk banks may heighten breastfeeding awareness in the community at large