Study Report
One Arm, Open Label, Prospective, Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Scale Up of Non-Surgical Circumcision when Performed by Nurses in Resource
Limited Settings for HIV Prevention
MUTABAZI Vincent Rwanda Ministry of Health
AIDS 2012 Conference July 22nd-27th , 2012
Rwanda national goal: VMMC to 2 million men in 2 years to
decrease HIV incidence by 50%; attainable only if task shifting
is possible to nurses, as there are not enough physicians.
Rwanda seeks innovation to achieve national goal – surgical
MC not possible, known devices require skill & cutting.
Background
Non Surgical MC
◦ No sterile settings
◦ No injected anesthesia
◦ Bloodless procedure
◦ No sutures
◦ FDA approved, CE Mark
PrePex Innovation
Rwanda PrePex clinical studies:1. Safety (physicians) - published in J-Aids2. Randomized controlled study comparing
PrePex MC to surgical MC – accepted for publication in J-Aids
3. Nurses cohort study – in writing process4. Planned study - Adolescents (ages 10 to 17)
Background
Rwanda received official recommendation by WHO to scale
up with PrePex after visiting and auditing studies in
Rwanda, and following precise clinical roadmap required.
Rwanda conducted over 4200 PrePex MC to date, and is
now routinely used.
Background
590 adult male subjects
10 nurses with no experience in MC or PrePex
were formally trained = 5 PrePex teams
Intervention – PrePex MC
Follow up period of up to 8 weeks
Nurses Study Design
l
MethodsPlacement Procedure
7 days later - Removal Procedure
a - Sizing b – Applying Anesthetic
cream
c – Marking Line
d – Placing Device
e - Dischargin
g
a – Removing Necrotic foreskin
b – Piercing Elastic Ring
c – Extracting Inner Ring
d – Dressing the wound
To validate the safety of the PrePex MC when performed by nurses, by means of rate of incidence of Adverse Events and Device-related Adverse Events
Primary Endpoint
Efficacy: Rate of complete MC (Glans completely exposed) Evaluation of Training efficacy
◦ Procedure time - first 125 subjects vs. last 125 subjects◦ Procedure related AEs◦ Pain assessment◦ Time to complete healing
Secondary Endpoints
Results
590 adult male subjects
Average age : 25, SD 4
5 HIV positive
Demographics
Primary Endpoint: Safety
AE Frequency (N=590) Severity Incidence, 95% CI
Device related 2 Moderate 0.34% [0.04% - 1.22%]
Procedure related 1 Moderate 0.17% [0.00% - 0.94%]
Unrelated to device or procedure 2 Moderate 0.34% [0.04% - 1.22%]
Total AEs 5 Moderate 0.85% [0.28% - 1.97%]
No Severe AE, No Infection All AEs were easily resolved with minimal intervention
100% of subjects fully circumcised
Subjects healed completely on average day
33 after device removal SD 6.79
Efficacy
First 125 subjects
Last 125 subjects
Procedure time (Placement + Removal)
4min 58secSD 2min 46sec 2min 51sec
SD 42secPreparation time (Placement + Removal)
2min 48secSD 1min 17sec 1min 48sec
SD 46sec
Total MC time (Procedure + Preparation)
7 min 46 secSD 4min 3 sec
4min 39 secSD 1min 26 sec
Secondary Endpoint: MC time
Visual Analogue Scale (VAS) was used in order to assess the subject’s pain level
Secondary Endpoint: Pain Assessment
During Device
placement (no
injected anesthesi
a)
within 1 hour after
placement
During erection with device
Before device remova
l
During remova
l
After remova
l
Average Pain
1SD 1.3
0.48SD 0.8
2.7SD 2
0.2SD0.8
3SD 1.9
(For 5 sec)
0.9SD 1.3
Conclusions
AEs: Very low AE rate demonstrating high safety of PrePex by nurses
Training: Nurses with no prior knowledge, can be trained in 3 days course to perform Safe, Effective and Efficient MC.
Scale up – Q3 2012 Rwanda plans to initiate scale up program◦ Pilot of 10,000 to inform scale up (Global Fund, Gates)◦ 2 Million MCs in 2 years◦ ~150 teams of 2 nurses (full time – 8 hours a day)◦ 54 procedures per team per day (Placement +Removal)◦ 4000 MCs Per day (4000 placements 4000 removals)◦ 250 working days per year
MC Method – PrePex by nurses◦ Surgical MC as back up for contraindicated and escalation
Next Steps
Thank You