Title

Experience with introduction of PrePex device for medical male circumcision for HIV prevention in Kenya (2013-2017)

Presenter

Nandi Owuor

Authors

E. Odoyo-June¹, N. Owuor², K. Agot³, S. Davis⁴, J. Hines⁴, P. Musingila¹, C. Kisia⁵, K. Serrem⁶, A. Wanyonyi⁶, K. Bartilol⁶

Institutions

¹US Centers for Disease Control and Prevention (CDC), DGHT, Nairobi, Kenya, ²JHPIEGO, Kisumu, Kenya, ³Impact Research and Development Organization, Kisumu, Kenya, ⁴US Centers of Disease Control and Prevention, DGHT, Atlanta, United States, ⁵World Health Organization Kenya Office, Nairobi, Kenya, ⁶Ministry of Health, National STD/AIDS Control Program, Nairobi, Kenya

Background: Since 2013 Kenya has undergone the three stages outlined in the World Health Organization (WHO) framework for clinical evaluation of male circumcision devices to introduce PrePex in its Voluntary Medical Male circumcision (VMMC) program for HIV prevention. We present experiences from this process.
Description: PrePex was first introduced in Kenya in 2013 during pilot research which assessed its effectiveness, safety and acceptability among 417 adult men. Its safety and operational requirements were further evaluated among 2,195 men under active adverse events (AE) surveillance in routine health care settings in 2015 and 2016. In August 2016, PrePex was endorsed for an open-ended passive roll out which continues to date.
Lessons learned: In the pilot research phase, PrePex circumcision was effective and well-accepted but associated with a higher rate of moderate/severe AEs (5.9% vs 0.2%) and 1-2 weeks longer time to healing than conventional surgical circumcision. Under active AE surveillance, PrePex remained well accepted and with lower moderate/severe AE rate (0.3%) as providers gained experience in its use. In the ongoing passive roll out, 1,134 PrePex circumcision have been conducted and 5 AEs (including one non-fatal tetanus) reported. In 2017, WHO reported a 30 fold higher risk of tetanus associated with PrePex compared to conventional surgical circumcision and recommended full immunization against tetanus (TT) prior to PrePex placement; this let to operational challenges undermining its further roll out.
Conclusions/Next steps: Although PrePex circumcision was initially shown to be effective, safe and well accepted in Kenya, the new requirement for documented full TT immunization before its application has revealed a gap in immunization coverage among Kenyan males. This has hampered widespread use of PrePex as few Kenyans have documentary evidence of full TT immunization and logistics for multiple clinic visits for immunization before PrePex placement are challenging. Thus, PrePex circumcision should only be rolled out in settings with high TT coverage among eligible males or where provision of protective doses of TT before each placement is feasible. Innovative Strategies are needed for efficient use of PrePex in VMMC while minimizing the risk of tetanus.

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