Sandy Gove WHO HIV Department

HIV Care/ART
Card is on the last 2 pages of this module
Patient monitoring needs to be integrated within comprehensive
HIV care and
ART!

Patient monitoring guidelines are based on:
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Standardized core and other data elements- agreed by WHO, CDC,
USAID, PEPFAR, multiple NGOS attending a WHO Patient
Monitoring meeting in March 2004
Collecting and analyzing only what is needed for patient management and for clinic, district and national management
Allowing flexibility for additional data collection and analysis
However:
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Clear distinction is made between what is essential and what should be reserved for extra operational research or data summaries.
If data collection is not simple, it can be a barrier to scaling-up ART.
MORE IS NOT BETTER!

TB
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Standardized treatment card
Standardized register
Globally standardized definitions
Deliberately constrains data collected
Based on long experience
Recently, new TB-HIV indicators
Disease-specific (vertical)
ART/ chronic HIV care-
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Builds on TB experience but with key alterations
Also requires a simplified disease-specific system
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Can pave the way or fit with similar methods for diabetes, other 'true' chronic illnesses
Paper base is important for feasibility

New in HIV care and not yet eligible for ART
A
New in HIV care and eligible for
ART
C
Nonnaïve patients to ART who are not Transfer In with records
Enrolled in HIV care and not yet eligible for ART
B
(Total = new + continuing)
Enrolled in HIV care and eligible for ART
D
( Total = new + continuingincludes those who decline ART) Died in preART care
Lost
Transferred out
Enrolled in HIV care and eligible and ready for ART
E
New on ART this month
G
Total ever started on ART in this facility F

TI = Transfer In with records
Add to cohort according to ART start date
New on ART this month
G
Start or continue on original first-line ARV regimen
H
Substituted to alternative first-line ARV regimen
I
DEAD after starting ART
TO = Transfer out
LOST
STOPped ART
(some Restart)
Switched to second-line
(or higher) ARV regimen
J

HW fills out
HIV care/ART card
.
Card defines minimal data to be collected.
HW codes are on the card
If switch to second line, substitutions, stop, etc.
—> MO decides, consults, log book, clinician coding listrecord on card
Pre-ART register
Monthly ART register
Cohort analyses at 6,12 months then yearly —
▪ Calculate indicators for clinic use only
▪ Calculate agreed district, national, international indicators
Monthly (cross-sectional) report
Input to monthly drug orders if required
District
Regional team to MOH to AFRO, HQ, agencies

Patient monitoring system
 Paper system is based on 6 items:
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A patient-held card
A facility-held chronic care card
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HIV Care/ART Card or
Same data elements in another format
HIV Care pre-ART register
ART Register
Monthly report (updated from
Cohort analysis report
 This can serve multiple needs:
Format of the card can be changed.
Standardized variables and codes are what is important.
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 Direct patient care (facilitates paradigm shift from Acute to Chronic
Care)
Drug supply monitoring and preparation of facility drug orders
Data summarized and reported to meet district and national programme needs and track progress to targets (3x5; 2,7,10; etc)

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Agreement is being finalized on the standardized data elements
 Definitions
 Coding
Freedom to:
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Use different formats including full patient chart
Collect additional data
Country adaptation, as clinical guidelines are adapted
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If no INH prophylaxis for HIV patients, no column on card
Etc

 Most important to standardize system nationally with allowances for collecting more data/different formats for patient cards or charts:
 Number pages per patient- visit
 Wide range from .05 (multiple visits on single card; extract key data) to 8 pages
 Card versus multiple page chart

Simplest, limit paper:
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Clinical review assisted by laminated form
Record key treatment data and pertinent positives
Other details may be in patient-held exercise book or 'patient passport'
Example: IMAI; Malawi
More elaborate:
 All positives and negatives of clinical review recorded
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Detailed treatment data
Requires full chart
What is really needed?

 Education:
 HIV basics, disease progression
 Treatments available
 Support
 Psychosocial
 Disclosure
 Family
 Prevention
 Adherence
 Preparation
 Decide when readyresults clinical team meeting
 Support
 Problem solving

When registered for HIV care
Date HIV+
Entry point
Start/stop dates prophylaxis- CTX, fluconazole
Pregnancy, TB
**When medically eligible for ART
**When medically eligible and ready for ART
(prepared for adherence, clinical team has met)
**When ART started plus unique patient identifier
Dead before ART
Lost or Transfer out before ART

 Cohorts formed in ART register (not PreART register) – by month
 Date ART started, unique identity number
 Why eligible 1=clinical only 2=CD4 3=TLC
 At start ART: function, weight, (CD4)
 Same as PreART register (transfer)
 Start/stop dates prophylaxis- CTX, fluconazole
 Pregnancy, TB

 Original regimen (coded)
 Substitutions within first line and switches to second line-- reason (code) and date
 Months 0 to 24:
 Each month: current regimen (coded)
 At 6, 12 months: function, weight gain > 10%,
(CD4)
 Then each year: function, (CD4)

1 Toxicity/ side effects
2 Pregnancy- planned treatment interruption
3 Treatment Failure
4 Poor Adherence
5 Illness, Hospitalization
6 Drug out of Stock
7 patient lacked financial Resources
8 other patient Decision
9 planned treatment Interruption (put reason )
10 Other

1 Toxicity/ side effects
2 P regnancy
3 Risk of pregnancy
4 due to new TB
5 New drug available
6 Drug out of Stock
7 0ther reason (specify)_____________
Reasons for switch to 2nd-Line Regimen only:
8 Clinical treatment failure
9 Immunologic failure
10 Virologic failure

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Monthly report:
 New and cumulative ever:
 Enrolled in HIV care
 S tarted on ART at this facility
Disaggregated by sex, pregnancy, age
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Transfer in (already on ART)
Restart ART
Patients eligible for ART but not started
 ARV regimens- number on
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Each regimen
First-line
Second-line
 Lost, Dead, Stopped, Transfer out
Cohort data for last month:
Median CD4: baseline, 6 and 12 mo on ART
Picked up ARVs 5/6 or 10+/12 months
Cohort analysis
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(quarterly or other periodicity)
Patient status:
 Alive- on or off ART, regimen
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Dead
Lost
Transferred out
Functional status
Proportion with > 10% weight gain
Proportion with CD4>200

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Proportion of patients on ART with weight gain > 10% (6, 12 mo)
Proportion working, ambulatory, bedridden
 Proportion alive and on ART at 6,12 months then yearly
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Proportion still on a first-line regimen
Proportion still on original first-line regimen
Proportion who have substituted to an alternative first-line regimen
Proportion switched to a second-line (or higher) regimen
Proportion of CD4 counts done which are >200 (optional)
Proportion of viral loads which are below 400 copies/ml (optional)

Register at
Health centre
Nursing assistant, lay providers
Treatment Centre at
District Hospital
/
HC IV
Clinical team
Consult, refer, back-refer, visit MO,
MD
Nursing assistant, lay providers
Clinical team
Visits by district or regional ART team/coordinator-
Help with registers, reports, cohort analysis

Cumulative- Total registered on ART since start
Cohort- Number registered in that quarter
 Alive and on ART
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On original first-line regimen (Start)
On alternative first-line (Substituted)
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 On second-line regimen (Switched)
Stopped
Defaulted – ? call 'Lost' to distinguish from TB
Transferred out
 Of those alive: ambulatory, at work, side effects, drug adherence >95%

 Hanging files- cards are stored sequentially
 Patient held cards with number and date starting ART

Designed so it can enter at various steps and be interchangeable with paper
 Paper card- electronic  generate register
 Paper card to paper register  electronic entry
 Paper card to paper register to monthly report, cohort reports  send or call by mobile phone  computer entry
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Computer generated paper register
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For 2006-2007
For use in facilities without electronics
For back-up when computer doesn't work
Compatible Palm entry (Satellife project)

 For monthly and cohort report data
 To handle Transfer In and Transfer Out patients
 Needs to link with drug supply

 Do at the same time as the adaptation of the clinical guidelines
 In Ethiopia, added 7 hours to first 3 day adaptation workshop

 First pre-tested in Masaka region (4 districts), Uganda when training 70 health workers in February 2004.
 Registers introduced during post-training on-site visits in
March and April 2004
 Many health workers had made up their own registers.
 Used in Hoima Region (4 districts) Uganda with pretest of training materials to support use of the registers

 Variables in the card and registers (TB status, clinical stage, prophylaxis, FP status, ART eligibility /regimen, etc) are embedded in the 4.5 day Basic ART clinical training course.
 Health workers learn the clinical care process and how to fill out the card at the same time, with exercises and practice.

 As part of the 4.5 day Basic ART Clinical
Course workshop
 As 4 hour additional training for those who will do patient tracking and monitoring in the health facility
 Training "refreshed" during on site posttraining visits: individual training

 Used in 18 facilities (1 Regional Hospital AIDS Clinic, 1
ART Clinic -600 patients, 4 District Hospital AIDS Clinics,
12 HC IV and III)
 Slightly revised after first 4 weeks of use

Feedback during on-site visits after training (not quantitative due to the limited number of facilities and recent introduction):
 HW: Useful tool providing streamlined information
Easy to fill out the card while doing the clinical review- part of the same process
Easy to transfer info into the register
Easy to quickly perform clinical review on the basis of data collected during previous visits
 Trainers: 45 minutes needed to "refresh" on how to fill out the card and show how to use the register.

 Progressively replacing a 4 page HIV Care /ART record as ART is scaled-up from 100 to 600 patients
Feedback from health workers:
 HW: Useful tool providing streamlined information
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Around 20 minutes per patient are saved since using this card
They like "everything on one page" – demographic, clinical and ART data

 District outpatient, health centre III/IV: paper card
 Agreed data into paper register; monthly reports, clinical team uses date
 Mobile phone
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District or regional team enters register data into computer  cohort analyses, indicators
Enter agreed data into palm or computergenerate monthly reports
Computer generation of cohort analyses and indicators

In clinics with ART services, a more specific indicator:
Numerator:
Patients on ART
UNGASS indicator based on total patients receiving
ART
Denominator:
Patients medically eligible and ready for ART
These patients have all accessed services.
Denominator: estimated patients with AIDS (15% those infected)

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% patients with good adherence
 Review reasons for fair or poor adherence
Patients with special problems
% patients referred
Identify patients for review at clinical team meetings
 Patient monitoring as tool for quality improvement
Card sorts, stickers, flags
Motivation, needs to be satisfying and possibly fun

 Training to fill out HIV Care/ART Card integrated within WHO Basic ART Clinical
Training course
 Module on how to fill out registers, do card sorts, monthly reports, use data- for health worker or 'professional' lay provider or HW
 Module on supervising and summing monthly and cohort analysis reports (similar to TB district coordinator training module) – district coordinator

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Importance of supporting card/register with training materials
 Need rapid regional review and further pretesting
Timeliness-
 Programmes are starting to treat patients
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Training is happening
Staff are making up cards and registers in absence of simple standards
Urgent need to address children
 Draft card for further expert input

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Logistic and information system to handle Transfer in/Transfer out-- with records
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Add retrospectively to cohort according to when started ART
Will become an increasing proportion of patients over time, with return to work, normal mobility
Restart after treatment interruption
 When is restart permitted? Different circumstances--
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Deliberate treatment interruption in first trimester pregnancy
Lost or very poor adherence- ? Restart
 Adjust if planned treatment interruptions later recommended
 Goes back into the same patient record (line in the register)
 Number, weeks of each treatment interruption retained on cardcould be used in special analyses
Nonnaïve patient on ART from other sources
 Goes into HIV Care PreART register (queue in rationed system)must qualify (determine that medically eligible) and be ready