PREPEX

Safety, efficacy and acceptability study of non-surgical male circumcision device for young adolescent male population

PrePex® Male Circumcision (MC) has been demonstrated as an effective and scalable strategy to prevent HIV infection in low- and middle-income countries. In this project, the safety, efficacy and acceptability of non-surgical male circumcision device PrePex® for young adolescent male population will be assessed, including contraindicated participants and Day 0 Foreskin Removal Procedure scheduled to undergo voluntary circumcision in an effort to prevent the spread of HIV in resource limited setting, performed by clinical officers and nurses. The study at Tuungane Youth Centre, Kisumu has following primary safety objectives:

  • assess feasibility, safety and device detachment of non-surgical PrePex® device on adolescent male population ages 10 to 12 years focusing on any associated serious adverse events;

  • assess feasibility, safety and device detachment of PrePex® device on contraindicated adolescent male population ages 10 to 12 years focusing on any associated serious adverse events; and

  • assess feasibility, safety and device detachment when Day 0 FRP on adolescent male population ages 10 to 12 years focusing on any associated serious adverse events; and

  • assess feasibility, safety and device detachment when Day 0 FRP on contraindicated adolescent male population ages 10 to 12 years focusing on any associated serious adverse events when performed by clinical officers or nurses.

The results of the study is expected to inform the scale up of non-surgical PrePex® device as alternative to supplement surgical MC in resource limited clinical settings in Kenya and sub-Saharan Africa.

Study Contact: Kawango Agot (Email: kawango@impact-rdo.org )
Principal Investigator:Kawango Agot PhD, MPH (Impact Research and Development Organization, IRDO)
Co-Investigators:Maurice Onyango, (Impact Research and Development Organization, IRDO), Bernard Ayieko, (Impact Research and Development Organization, IRDO), Peter Ouma, PhD (Impact Research and Development Organization, IRDO), Ohaga Spala PhD (Impact Research and Development Organization, IRDO)
Funding:CIRC MEDTECH


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CONTACT

Impact Research and Development Organization
Baring Road-Milimani
P.O. Box 9171-40141
Kisumu City
(254)-057-2020132
(254)-727-688550
(254)-738-772119
info@impact-rdo.org

PrePex

The Research

PREPEX

Safety, efficacy and acceptability study of non-surgical male circumcision device for young adolescent male population

PrePex® Male Circumcision (MC) has been demonstrated as an effective and scalable strategy to prevent HIV infection in low- and middle-income countries. In this project, the safety, efficacy and acceptability of non-surgical male circumcision device PrePex® for young adolescent male population will be assessed, including contraindicated participants and Day 0 Foreskin Removal Procedure scheduled to undergo voluntary circumcision in an effort to prevent the spread of HIV in resource limited setting, performed by clinical officers and nurses. The study at Tuungane Youth Centre, Kisumu has following primary safety objectives:

  • assess feasibility, safety and device detachment of non-surgical PrePex® device on adolescent male population ages 10 to 12 years focusing on any associated serious adverse events;

  • assess feasibility, safety and device detachment of PrePex® device on contraindicated adolescent male population ages 10 to 12 years focusing on any associated serious adverse events; and

  • assess feasibility, safety and device detachment when Day 0 FRP on adolescent male population ages 10 to 12 years focusing on any associated serious adverse events; and

  • assess feasibility, safety and device detachment when Day 0 FRP on contraindicated adolescent male population ages 10 to 12 years focusing on any associated serious adverse events when performed by clinical officers or nurses.
The results of the study is expected to inform the scale up of non-surgical PrePex® device as alternative to supplement surgical MC in resource limited clinical settings in Kenya and sub-Saharan Africa.

Study Contact: Kawango Agot (Email: kawango@impact-rdo.org )
Principal Investigator:Kawango Agot PhD, MPH (Impact Research and Development Organization, IRDO)
Co-Investigators:Maurice Onyango, (Impact Research and Development Organization, IRDO), Bernard Ayieko, (Impact Research and Development Organization, IRDO), Peter Ouma, PhD (Impact Research and Development Organization, IRDO), Ohaga Spala PhD (Impact Research and Development Organization, IRDO)
Funding:CIRC MEDTECH

Our Partners