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