Transcript MTCT-Plus Clinical Manual - World Health Organization

The MTCT-Plus Initiative
Wafaa El-Sadr, MD, MPH
Mailman School of Public Health
Columbia University
What is the MTCT-Plus Initiative?
MTCT-Plus Initiative is an HIV care
and treatment program that
establishes HIV primary care
services for
• women identified as HIV infected
through perinatal prevention
programs
• their infants and children
• family/household members
Why Was this Model Selected?
• Rapid global expansion of pMTCT programs
• Recognition of consequences of loss of
mothers on health of the child, the family and
the community and opportunity to have a
positive impact on the families
• Appeal of linking a treatment intervention
(MTCT-Plus) to a prevention intervention
(pMTCT)
Fundamentals of MTCT-Plus
• HIV primary care that includes provision
of antiretroviral therapy
• Family-centered care
• Comprehensive care via
multidisciplinary team with attention to
clinical, psychosocial and environmental
issues
• Focus on adherence and retention in
care
Demonstration and Planning Sites
Thailand
MTCT-Plus site
Planning grant
MTCT-Plus Demonstration Sites
Cote D’Ivoire
Kenya (2)
Mozambique
Rwanda
South Africa(3)
Thailand
Uganda(2)
Zambia
Planning Grants
•
•
•
•
•
•
•
•
•
•
Cameroon
Democratic Republic of Congo
Ethiopia
Kenya
Mozambique
Nigeria
South Africa
Tanzania
Zambia
Zimbabwe
Site Characteristics
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•
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Local leadership
Diverse settings
Varied experience in HIV care
Varied resources
Service Delivery Sites
Site support activities
Site Monitoring (JSI)
Data management (JSI)
MTCT-Plus
Secretariat
Partner organizations
Mailman School of Public Health
Columbia University
Women’s Leadership Group
Site Directors Group
Working groups:
• Clinical care
• Training
• Procurement
• Evaluation
• Research
What Resources Does MTCTPlus Provide to the Sites?
• Funding to support staff
• Funding to support key laboratory
tests e.g. CD4 cell count, infant
diagnostics
• Funding to support patient costs
e.g. transportation
• Funding to enhance site capacity
and infrastructure
continued…
Other Resources Provided by
MTCT-Plus
• Clinical Manual and treatment algorithms
• Central procurement of MTCT- Plus
medications: cotrimoxazole, isoniazid, dapsone,
antiretrovirals, multivitamins
• Staff training with focus on
multidisciplinary team of providers
• Site support
• Data management
• Program evaluation
Enrollment into pMTCT programs
HIV-infected
partners
and children
pMTCT programs
Women attending ANC clinics
Enrollment into
MTCT-Plus
MTCT-Plus
Long-term HIV care services, including:
• Family-centered services
• Clinical & immunologic monitoring
• TB prophylaxis & treatment
• Prophylaxis for opportunistic infections
• Antiretroviral therapy when indicated
• Psychological & social support services
• Prevention services
• Nutritional counseling & support
• Outreach activities
Timeline
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•
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•
•
Sites announced in July 2002
Facility readiness
Development of Clinical Manual
Recruitment of site staff
Establishment of site procedures
and resources
• Procurement plans for medications
• Staff training
MTCT-Plus Monitoring and Evaluation
Goals
• Provide means to monitor patient
progress and outcomes
• Permit ongoing monitoring and
evaluation of delivery sites and
sharing of experiences across sites
• Allow monitoring and evaluation of
overall program impact
Patient Data Collection System
Guiding Principles
• Patient care is facilitated by availability of
complete medical record
• Care is provided by multidisciplinary
team e.g. adult provider, pediatric
provider, outreach workers, etc
• Sites have diverse resources and
capabilities
• Importance of rapid feedback to the sites
• Need for cross-site evaluation and
assessment of key parameters for
programmatic impact
Patient Records
Site Resources
• Medical record system varies from site to
site
– Few have established systems for continuity
care
– Few have mechanisms for documentation of
contact with non-clinical providers
• Few have computers in the clinical
setting
• Few have patient databases and data
entry/management experience
MTCT-Plus Clinical Manual
• How to manual rather than guideline
• Includes step by step instructions
with regard to adult/pediatric care
• Includes roles of clinical and nonclinical providers
• Visit by visit instructions
How Were the Data Forms
Developed?
• Patient forms were developed to
reflect the principles and
procedures described in the Clinical
Manual
• Site feedback and pilot testing
• Translated into French, Portuguese
and Thai
Characteristics of the Patient
Data Forms
•
•
•
•
Simple
Skip patterns as appropriate
Use of checkboxes
Provide space for extra notes by
providers
• Multi-copy to serve as patient chart
at some of the sites
• Data Collection Manual
Types of Forms
• Separate forms were created for adult
and pediatric patients (infants/children < 15 yrs)
• Forms were designed to collect
patient information at various points of
the program including:
–
–
–
–
–
–
Intake and enrollment visits
Follow-up visits
Laboratory test results
Pediatric HIV test results
Non-Clinical contact visits
Program discontinuation
MTCT-Plus Adult Intake Form
Patient Name:
Patient ID Number:
Site Code:
Facility Code:
Family Code:
Intake Date:
/
day
optional
1. Date of birth:
/
day
3. Sex:
Female
month
year
year
years
Male
4. Type of patient being enrolled:
A.
month
Enter 99 in day, month, or year space if information is not known
/
2. Age at last birthday:
/
Note: only one category - A, B, or C - is allowed
Woman who is receiving, or has received, antenatal care at an affiliated pMTCT site
Fill in one circle below and complete appropriate dates
Antepartum
/
Estimated date of delivery is:
day
Postpartum
month
/
Date of delivery was:
day
B.
/
year
/
month
year
Member of household of woman already enrolled in MTCT-Plus
Fill in one circle below, index woman's ID, and relationship
Index Woman's Patient ID:
Partner of HIV-infected enrolled woman
Other HIV-infected adult from household of enrolled woman
Relationship to index woman:
C.
Health care worker or family member of a health care worker
Note: For health care workers please transmit only
the information above to the Data Management
Center. Use of the rest of this form is optional.
MTCT-Plus Pediatric Intake Form
Patient Name:_________________________________________ Patient ID Number:
Site Code:
Facility Code:
Family Code:
Intake Date:
/
day
optional
/
1. Date of birth:
day
2. Age at last birthday:
3. Sex:
Female
/
month
years
/
month
year
Enter 99 in day, month, or year space if information is not known.
year
months
or if < 1 year old:
Male
4. Patient's relationship to woman enrolled in MTCT-Plus (index patient):
Fill in one 'o' below and index patient (mother's) ID:
Child born to enrolled woman from most recent pregnancy
Index Patient (Mother's) ID:
Other child born to enrolled woman
Other child/adolescent living in household
5. Has the child ever attended school?
school?
Yes
No
Not applicable (child not school age)
5 a. If yes, how many years of school has the child completed?
5 b. If yes, is the child currently attending school?
Yes
No
years
MTCT-Plus Patient Locator Form
DO NOT RETURN THIS FORM TO THE DATA MANAGEMENT CENTER
Patient ID Number:
Patient Name:
Site Code:
Facility Code:
Family Code:
Date Form Completed:
/
optional
1. Patient Contact Information:
2. Other Contacts for the Patient:
Contact 1:
Contact 2:
Contact 3:
Index Woman's
ID Number:
day
/
month
year
Enrollment Forms
(Adult and Pediatric)
• Records clinical information:
– past medical history
– past and current use of ARV or medication for
OI prophylaxis
– family planning methods/pregnancy status
– current signs and symptoms/physical exam
– WHO staging indicator conditions
– Lab tests and referrals requested
• To be completed by clinician conducting the
examination
Adult Enrollment Form
MTCT-Plus Adult Enrollment Form
Patient Name:
Site Code:
Patient ID Number:
Facility Code:
Family Code:
Enrollment Date:
/
day
optional
/
month
1. Does the patient have a history of, or currently have, any of the following conditions?
If yes, fill in appropriate 'o' next to each condition
Current/Past
Diagnosed Conditions
Tuberculosis
Hepatic disease
Renal disease
Anemia
Mental illness
Other 1 (specify):
______________
Other
2 (specify):
______________
Other 3 (specify):
______________
Comments:
year
Yes
No
If yes, diagnosis, comments, and
date of most recent diagnosis (if known)
Active
Inactive
Yes
Yes
Yes
Yes
Yes
Yes
Yes
2. Has the patient received Isoniazid (INH) prophylaxis in the past?
Yes
No
Adult Enrollment
Adult Enrollment
9. Physical Examination
Temperature
.
°C
Examinations
Ears, Nose & Throat
Head & Neck
Cardiovascular
Lungs
Abdomen
Lymph Nodes
Skin
Urogenital
Musculoskeletal
Neurological
Other 1 (specify):
Other 2 (specify):
* Karnofsky
Score
Height
cm
Weight
Normal Abnormal
Normal health 100%
Minor symptoms 90%
Normal activity with some effort 80%
Unable to carry on normal activity, able to care for oneself 70%
Requires help with personal needs 60%
Not Done
kg
Karnofsky Score *
Comments / Descriptions
Disabled 50%
Requires considerable assistance, medical care 40%
Severely disabled, in hospital 30%
Very sick, active support needed 20%
Moribund (near death) 10%
%
Adult Enrollment
10. Does the patient currently have, or has the patient ever had, any of the following conditions?
Fill in appropriate 'o' next to each indicator condition
WHO Stage 1
Asymptomatic HIV Infection
Persistent Generalizied Lymphadenopathy (PGL)
WHO Stage 2
Herpes Zoster (within last 5 years)
Minor Mucocutaneous Manifestations
Recurrent Upper Respiratory Tract Infections
Weight Loss < 10% of Body Weight
WHO Stage 3
Severe Bacterial Infections (i.e., pneumonia,
pyomyositis)
Oral Candidiasis (Thrush)
Unexplained Chronic Diarrhea (> 1 month)
Unexplained Prolonged Fever (intermittent or
constant, > 1 month)
Oral Hairy Leukoplakia
Tuberculosis, Pulmonary (within previous year)
Weight Loss > 10% of Body Weight
WHO Stage 4
Candidiasis (Esophageal, Bronchi, Trachea, or Lungs)
Cryptococcosis, Extrapulmonary
Cryptosporidiosis with Diarrhea (> 1 month duration)
Cytomegalovirus Disease (other than liver, spleen, lymph nodes)
Herpes Simplex (mucocutaneous>1month, or visceral any duration)
HIV Encephalopathy
HIV Wasting Syndrome
Kaposi's Sarcoma (KS)
Lymphoma
Atypical Mycobacteriosis, Disseminated
Mycosis, Disseminated Endemic (i.e., Histoplasmosis,
Coccidiodomycosis)
Tuberculosis, Extrapulmonary
Pneumocystis Carinii Pneumonia (PCP)
Progressive Multifocal Leukoencephalopathy (PML)
Salmonella Septicemia, Non-typhoid
Toxoplasmosis, CNS
10a. Based on the table above, what is the highest WHO Staging Indicator Condition the patient has experienced
to date?
WHO Stage 1
WHO Stage 2
WHO Stage 3
WHO Stage 4
MTCT-Plus Pediatric Enrollment Form
Patient ID Number:
Patient Name:
Site Code:
Facility Code:
Family Code:
Enrollment Date:
/
day
optional
1. What is the child's current HIV status?
/
month
year
HIV-exposed, status indeterminate
HIV-infected
2. Child's Birth Weight:
.
kg
Enter 9.99 if unknown
3. Did the patient's mother receive ARV(s) ante-, intra-, and/or postpartum?
Yes
No
Unknown
If yes, fill in 'o' next to ARV(s) received by the mother:
Antiretroviral
Nevirapine (NVP)
Dosing Period
Antepartum
Number of
doses received
1 dose only
>2 doses
Intrapartum
Postpartum
Zidovudine (AZT)
Antepartum
Intrapartum
Postpartum
Lamivudine (3TC)
Antepartum
Intrapartum
Postpartum
Other (specify):
Antepartum
Intrapartum
Postpartum
1 dose only
>2 doses
Total number of
weeks on treatment
Enter 01 if < 1 week,
and round
to highest week for
all others
Follow-up Forms
(Adult and Pediatric)
• Information on the enrollment form
• Additional information:
– ARV adherence questions (if on ARV)
– other health care provider use
– MTCT-Plus services received
• To be completed by clinician conducting the
examination
Adult Follow-up Form
2. In the interval since the last visit, has the patient taken any of the following antiretroviral medications?
Yes
If yes, fill in the 'o' indicating if, since the last visit, an ARV was started for the first time, if the current
If no, skip to
regimen was continued, or if an ARV was stopped
Question 4
Medication
ARV
ARV
ARV Stopped
Started Continued Reasons for ARV
For First
Discontinuation*
Time
Comments
Zidovudine (AZT)
Lamivudine (3TC)
Stavudine (d4T)
Didanosine (ddI)
Abacavir (ABC)
Nevirapine (NVP)
Efavirenz (EFV)
Nelfinavir (NFV)
Other 1 (specify):
Other 2 (specify):
* Primary and Secondary Reasons for Antiretroviral Discontinuation:
1 = Side Effects / Toxicity
4 = Treatment failure
2 = Disruption in Drug Supply / Stock out
5 = pMTCT Treatment
3 = Patient Non-Adherence
6 = Drug Interaction
7 = Patient Refused
8 = Unknown
9 = Other, specify:
No
Adult Follow-up Form
2a. If any ARV medications were started for the first time in the interval since the last visit,
enter start date:
/
day
/
month
year
Comments:
3. During the last seven days, how many of her/his pills did the patient take?
Read list to patient, fill in one 'o' only
None of her/his pills
About half of her/his pills
All of her/his pills, every day
Very few of her/his pills
Most of her/his pills
3a. If the patient missed any pills in the last seven days, what reason(s) did she/he provide?
Read list to patient, fill in 'o' for all that apply
Forgot
Clinic ran out of medication
Patient ran out of pills
Felt too ill
Lost her/his medication
Other reason:
Side effects
Disclosure issues
If all taken,
skip to Question 4
Laboratory Result Form
Infant HIV Test Results
MTCT-Plus Infant HIV Test Results Form
Patient Name:
Patient ID Number:
Site Code:
Facility Code:
Family Code:
Mother's ID Number:
optional
I. Initial HIV Testing (recommended at 6-12 weeks of age)
HIV Test Results:
Positive
Date of HIV Test:
Negative
Method of HIV Testing:
Inconclusive
BDNA
DNA PCR
/
day
/
month
year
P24 Antigen
Other:
RNA PCR
II. Additional Infant HIV Testing
Additional Test 1 Reason:
Confirmatory HIV Testing
HIV Test Result:
Positive
Negative
Method of HIV Testing:
Clinical Indication
/
Date of HIV Test:
Inconclusive
Final HIV Testing
day
Elisa
BDNA
RNA PCR
Western Blot
DNA PCR
P24 Antigen
HIV Rapid Test
Other:
/
month
year
Non-Clinical Contact Form
• Records patient contacts other than
clinical visits including:
–
–
–
–
–
–
–
Adherence Support/Counseling
Support Group
Psychosocial Counseling
Home Visit
Social Services
Nutrition
Other Referral
• To be completed by appropriate person of
the team e.g. counselor, peer worker,
social worker, educator, outreach worker
Non-Clinical Contact Form
MTCT-Plus Patient Non-Clinical Contact Form
Patient ID Number:
Patient Name:
Site Code:
Facility Code:
Family Code:
Index Woman's
Patient ID Number:
optional
Date of Contact:
/
day
If applicable
/
month
year
1. Purpose of Patient Contact:
Fill in 'o' for all that apply
Adherence Support/Counseling
Support Group
Psychosocial Counseling
Home Visit
2. Notes on Encounter:
Social Services
Nutrition
Referral
Other (specify):
Data Collection Options
• At sites where data forms will serve as
medical records, duplicates are sent to
the Data Management Center (DMC)
• For sites using their own medical records
system, data are abstracted and sent to
DMC
• For sites able to enter data on-site,
MTCT-Plus database is provided and
files emailed to DMC
MTCT-Plus Patient Data Manual
– Description of patient data forms including
detailed directions on how to answer
questions
– Instructions on completion of MTCT-Plus
forms
– Training on-site and by conference calls
Experience to Date
• Enrollment into MTCT-Plus program
began in February 2003
• As of May 30, 2003, 461 patients
have been enrolled at seven MTCTPlus program sites
Total Adults Enrolled (339)
Index Woman
No. (%)
Antepartum
108 (32)
Postpartum
149 (44)
Household Members
Partners
78
(23)
Number (% Female)
262 (77%)
Mean Age (range)
29 (17-51)
Baseline Median CD4 Count
201 cells/mm3
Baseline WHO Stage (%)
Stage I
59%
Stage II
20%
Stage III
16%
Stage IV
4%
Eligible/On ARVs at baseline
111
Eligible/On OI proph. at baseline
160
Total Children Enrolled (122)
Child (recent pregnancy)
99
Other Child (born to index woman)
22
Number (% Female)
58 (47%)
Mean Age (range)
<1 yo: 3 mo (0-9 m)
>I yo: 3 yrs
Baseline Median CD4 Count
651 cells/mm3
HIV-exposed, indeterminate
97
HIV-Infected
25
CDC Category N
32%
CDC Category A (WHO Stage I)
28%
CDC Category B (WHO Stage II)
36%
CDC Category C (WHO Stage III)
4%
Eligible/On ARVs at baseline
5
Eligible/On OI proph. at baseline
100
Index Woman Enrolling Household Members
173
What can MTCT-Plus
Accomplish?
o decrease in morbidity and mortality
o further reduction in MTCT
o involve persons with HIV in the programs
o strengthen local health care capacity
o promotion of VCT, pMTCT cascade and
other HIV prevention strategies
o decrease stigma and enhance support to
persons with HIV in the community
o develop reproducible models of care in a
range of health care settings
Key Indicators
Patient-Related
•
•
•
•
•
Adherence with care
Adherence with treatment
Hospitalizations
Morbidity
Mortality
Key Indicators
Site-Related
• Women, children and partners
enrolled
• Patient retention
• Multidisciplinary team
• Patient satisfaction
• Staff retention
• Linkage to other clinical (e.g. Tb
programs), community programs
and resources
MTCT-Plus Program Impact
• Number of families enrolled and
retained in care
• Diversity of sites and models
• Expansion of program and sites
• Impact on prevention practices e.g.
VCT, sexual transmission
• Impact on attitudinal factors
including stigma
Expansion of MTCT-Plus Sites
Expansion of HIV Care and
Treatment Programs
MTCT-Plus
TB/HIV
Other care &
treatment
programs
The Way Forward
Actively seek answers to clinical
and operational questions
Acknowledgements
Foundations supporting the MTCT-Plus Initiative
Bill & Melinda Gates Foundation
William and Flora Hewlett Foundation
Robert Wood Johnson Foundation
Henry J. Kaiser Family Foundation
John D. and Catherine T. MacArthur Foundation
David and Lucile Packard Foundation
Rockefeller Foundation
Starr Foundation
United Nations Foundation