Challenges in monitoring ARV therapy

A clinical and public health view

of the issues involved

Charlie Gilks

SRM team, HIV department

The M&E Pipeline

INPUTS PROCESS OUTPUTS OUTCOMES IMPACT

MONITORING

Process Evaluation

EVALUATION

Effectiveness Evaluation

Core problem for ART Programmes

ART does not easily fit into M&E pipeline

• The only easy parts to define are the inputs

• Process is complex and open-ended

• Outputs differ according to the processes

• Outcome and Impact (the goals of therapy) are varied and have not been agreed upon

Quality not just quantity - numbers on ART

Processes and Outputs

• ART turns HIV into a chronic disease process- open-ended, continuous therapy with lifelong care

- in life, healthy people/healthier patients move around

- long-term adherence matters

• ART and the simplified Public Health approach- different treatments: first line and second line

- toxicity means some drugs have to change

- many patients will end up failing treatments

Outcomes and Impact

Several different measures of “effectiveness” – improved survival / mortality rates– quality of life– reduction in HIV transmission– drug resistance contained

Which should programmes be evaluated on?

How will this be decided?

This critically impacts the M&E process

Developing process indicators

Key is to simplify clinical decision making process

Then standardise indicators around this

Charlie’s four S’s - the core of ARV management:– Start according to guidelines on first-line ART– Substitute single drug for toxicity– Switch for failure to second-line ART– Stop and move to palliative care

sadly, this only works in english …. but the principle are the same

Addressing the Process Issues

The key is matching up different system flows

patients on treatment

drug supplies

money (fee for service)

All intersect at the point of dispensing ARVs

Different components with this linkage

What are the components - 1Patient identifier: mobility and life-long care

– unique– non-transferable– robust

Drug supply: link ordering to use– tracking stock to and in pharmacy– dispensing/prescribing log– avoid stock-outs, expiry on shelf and pilfering

What are the components - 2

• Patient records and forms: progress and Px – facility-based: clinical notes, patient registers– patient-held: treatment card

• Data collection system: new or integrated– data to central monitoring points– data transfer in timely fashion

(warehouse, MoH, M&E unit, budget centres)

Current approaches

Most projects use paper records (as does TB)

Complex, non-standardised data collection

Grave disadvantages with paper:– slow – inaccurate– insecure– labour-intensive

Paper may work in single facility but not robust

enough to go to scale, or for national reporting

What can technology offer ?

• Unique patient identifier - fingerprints

• bar-coding of drug cartons

• smart cards (clinic data and prescriptions)

• simple smart card readers – treatment centres– dispensing centres

• mobile telephone-based linkages

The “Luddite” view

Sceptics abound when technology is discussed• too fragile for developing countries• too complex for public sector to organise• too costly• staff not competent or skilled enough to use

There is no other way to monitor ART to scale

This is a unique opportunity to fast-tract change

Some conclusionsM&E of ART is complex and challenging

Need for consensus on goals of treatment

Processes can be simplified (around the 4S’s)

Standardised indicators can be developed

Facility-based paper records inadequate for task

“Technology” can and will have to be utilised