Prepex + Study

PI: Robert C. Bailey (UIC)
Investigators: Fredrick O. Otieno (NRHS), Supriya Mehta (UIC), Elijah O. June (CDC), Jason Reed (OGAC)
Duration: June 2014 – May 2016
Status: Awaiting enrolment
Study Sites: UNIM Research and Training Centre
Sponsor: National Institutes of Health; NIAID
Purpose: This proposed bridging study seeks to generate information on adverse events, time to complete healing and changes in CD4 counts, viral loads and viral shedding associated with PrePex circumcision of HIV-positive men. Its findings will inform development of policies regarding circumcision of HIV-positive men using the PrePex device
Significance: Voluntary medical male circumcision (VMMC) is a proven intervention for reducing HIV incidence in heterosexual men. To date, published safety and effectiveness studies on PrePex have been conducted among HIV-negative healthy adults. Currently there is no evidence to support policy decisions regarding PrePex circumcision for HIV-positive men. Given that PrePex achieves circumcision by ischemic necrosis and healing is by secondary intention, it is important to understand the course of these processes in HIV-positive men before widespread use of the device in national programs. It is also important to understand whether swelling and other consequences of PrePex displacement take a more severe course or need to be managed differently in HIV-positive men. Another important consideration for PrePex circumcision in HIV-positive men is the longer time to healing and potential for prolonged post-circumcision viral shedding. Kenya is currently planning to introduce PrePex in its VMMC program and has contacted partners to begin active surveillance of 1000 men circumcised using PrePex in routine clinical settings. The National MC Task Force has prioritized these active surveillance activities and has also prioritized: a bridging study such as the one proposed here of wound healing in HIV-positive men; studies of adolescent men; and studies in nomadic communities. Therefore, this proposed study is timely and addresses an important national priority.
Design: This is a prospective study to be conducted over a period of 16 months in Kisumu, Kenya, at the UNIM Clinic. The study will measure rate of moderate and severe adverse events, time to complete wound healing, CD4 t-cell counts, viral load, and penile viral shedding among 120 HIV-positive men circumcised through the PrePex device. Study procedures include HIV testing and counselling, medical history, physical examination, collection of blood and penile lavage specimens. Evaluations and data collection will occur at enrolment and device placement, at the Day 7 device removal, and at weekly intervals for 8 weeks post-placement or until the wound is fully healed and at 12 weeks. Data on pain, satisfaction, manipulation of device, and sexual activity will be collected during unscheduled visits along with extensive clinical notes for possible coding and qualitative and quantitative analyses.
Study Population: HIV-positive men ages 18 to 49 years voluntarily seeking medical male circumcision.
Study Size: A total of a120 HIV-positive men.
Study Aims:

Aim 1: To measure rates of moderate and severe adverse events among HIV-positive men circumcised using the PrePex device


Aim 2: Determine time to complete healing in HIV-positive men circumcised using the PrePex device

Aim 3: Assess changes in CD4 count, plasma viral load and penile viral shedding among HIV-positive men circumcised using PrePex device.

Aim 4: Using historical data from the same study site, compare time to wound healing and changes in CD4 counts, viral load and viral shedding in HIV-positive men circumcised using PrePex versus HIV-positive men circumcised using the forceps guided method.