Estimating the costs of early infant male circumcision in Zimbabwe: results from a comparative trial of AccuCirc and Mogen Clamp

KARIN HATZOLD , MD, MPH Population Services International

Collin Mangenah, CeSSHAR Zimbabwe Harsha Thirumurthy, UNC

8th International AIDS Economics NetworkPre-Conference MeetingJuly 19, 2014Melbourne, Australia

Study Background

EIMC is cheaper, quicker, simpler & has complete healing in less than 7 days with low rate of AEs

Zimbabwe plans to offer EIMC for HIV prevention alongside adult and adolescent VMMC

Currently EIMC devices prequalified by WHO

New device - AccuCirc – pre-packaged, disposable, potentially

usable by midwives

AccuCirc previously evaluated in Botswana, (single-arm study with 151 male infants)

Prequalification studies in ZimbabweComparative trial AccuCirc vs Mogen Clamp

Doctor delivered

n = 150

Ratio=2:1

Primary outcomes

Relative safety

Relative acceptability

Relative cost

Field trialAccuCirc only

Nurse mid-wife delivered

n=500

No randomisation

Primary outcomes

Safety

Acceptability

Cost

Costing research questions

What is the unit cost of EIMC in Zimbabwe?– AccuCirc– Mogen Clamp

What are the key cost drivers for EIMC in Zimbabwe? Role of various components:– Device and Commodities price – Personnel salaries– Facility capacity utilization– Nurse mid-wives procedure time

EIMC comparative trial: safety and acceptability results

150 eligible male infants enrolled– 100 Accucirc, 50 Mogen clamp

2 moderate (and quickly resolved) adverse events in the AccuCirc arm (95% CI 0.004-0.077) and 0 in the Mogen clamp arm (95% CI 0.0-0.089)

Nearly all parents (99.5%) reported great satisfaction with the outcome

All parents, regardless of arm said they would recommend EIMC to other parents, and would circumcise their next newborn son

EIMC Costing Methods

Unit costs– Direct (personnel, drugs, supplies, training & environmental

costs ) + indirect (capital & overheads)

Time and motion to calculate labor costs– Stopwatch & video camera captured time spent on each task

One way sensitivity analysis– Device price, Salaries, Site Capacity Utilization, Procedure

time

Analysis excludes – Costs to clients (transport, caregiver costs)– Demand creation costs

Key assumptions

Personnel 100% dedicated to EIMC Personnel Salaries based on PSI/Z & CeSHHAR scales Costs collected under pilot field study environment Use of MoHCC perspective excludes costs to clients, care

giving costs Analysis based on 3024 annual procedures based on site

capacity (12 procedures/day x 252 working days) Doctors trained by international consultants; nurses / mid-

wives trained by local master trainers AccuCirc device price = $10 (Clinical Innovations)

Cost Category - direct AccuCircCost($)/ EIMC

Mogen ClampCost($)/EIMC

Consumable supplies $15.01 $32.05 Non-consumable supplies $0.27 $0.10 Device cost $10.00 $0.21 Personnel costs $17.13 $17.13 Training costs $1.88 $1.88 Environmental costs $1.80 $1.20 Subtotal $46.09 $52.57 Cost Category - indirect

Capital equipment costs $0.04 $0.06Support personnel costs $5.50 $5.50 Subtotal $5.54 $5.56 TOTAL UNIT COST OF EIMC $51.62 $58.13

All costs in 2013 US$

Comparative trial costing results

Cost Category - direct DoctorCost($)/ EIMC

Nurse / mid-wife Cost($)/EIMC

Consumable supplies $15.01 $15.01 Non-consumable $0.27 $0.27 Device cost $10.00 $10.00 Personnel costs $17.13 $4.68Training costs $1.88 $0.95 Environmental costs $1.80 $1.80 Subtotal $46.09 $32.71 Cost Category - indirectCapital equipment costs $0.04 $0.04Support personnel costs $5.50 $5.50 Subtotal $5.54 $5.54TOTAL UNIT COST OF EIMC $51.62 $38.25

Cost Comparison of Comparative Trial and Field study**

All costs in 2013 US$ ** Based on 400 EIMCs delivered by nurse/midwife

One way sensitivity analysis

Percent change

AccuCirc Price

Personnel Salaries

Site capacity

utilizationProcedure duration

30% $41.24 $39.65 $36.74 $39.45

20% $40.24 $39.18 $37.16 $39.0510% $39.24 $38.71 $37.65 $38.65

Base case $38.25 $38.25 $38.25 $38.25

-10% $37.24 $37.78 $38.96 $37.84-20% $36.24 $37.31 $39.86 $37.44

Field study cost results cont’d

Total cost of EIMC procedure – $38.25 by midwives vs $51.62 by doctors

Would improvements by nurse mid-wives in time taken to perform a procedure impact the cost?

Improvement in time taken by nurse mid-wives on EIMC procedure leads to further reductions in the cost of an EIMC but by a small amount.

Conclusions EIMC using AccuCirc is cheaper compared to Mogen

Clamp ($51.62 vs $58.13) Nurse-delivered EIMC is considerably cheaper than by

doctors ($38.25 vs $51.62) Key cost drivers are device price, personnel costs, & site

capacity utilization Sensitivity analysis confirms device price, personnel

costs & site capacity utilization as key cost drivers Improvements in time taken to perform EIMC does not

lead to substantial cost reductions ($38.25 vs $ 37.44)

Recommendations

Device price is a large portion of AccuCirc costs; Need to negotiate price reduction

• Site capacity utilization is an important cost driver; Ensuring demand for EIMC is therefore critical

• Cost substantially reduced if EIMC is performed by nurse mid-wives instead of doctors (this is also likely to make procedure more widely available)

Acknowledgements

Centre for Sexual Health & HIV/AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe

Centre for Sexual Health & HIV Research, University College London, London, UK

Ministry of Health and Child Care, Harare, Zimbabwe

Population Services International-Zimbabwe, Harare, Zimbabwe

University of Zimbabwe, Harare, Zimbabwe London School of Hygiene & Tropical

Medicine, London, UK UNC Gillings School of Global Public

Health, NC, USA Bill & Melinda Gates Foundation, USA City Health Department, Harare, Zimbabwe EIMC Study team

Gerald Gwinji, MoH Zimbabwe Getrude Ncube, MoH Zimbabwe Owen Mugurungi, MoH Zimbabwe Cynthia Chasokela, MoH Zimbabwe Margaret Nyandoro , MoH Zimbabwe Nontando Mothobi, MoH Zimbabwe Ismail Ticklay, University of Zimbabwe Karin Hatzold, Population Services International Christopher Samkange, University of Zimbabwe Collin Mangenah, CeSSHAR; Frances Cowan, CeSHHAR; University College

London Judith Sherman, UNICEF Zimbabwe Webster Mavhu, CeSHHAR; University College

London Helen Weiss, London School of Hygiene & Tropical

Medicine Harsha Thirumurthy, University of North Carolina at

Chapel Hill Andrea Biddle, University of North Carolina at Chapel

Hill