HIV/AIDS

Review by the Technical Advisory Group on Innovations in Male Circumcision (TAG) of additional documentation relating to the safety of male circumcision methods

27 July 2016

Background

In March 2015, the World Health Organization (WHO) convened an informal consultation on tetanus and voluntary medical male circumcision (VMMC) to discuss recent cases of tetanus, which had been reported through the VMMC services within HIV prevention programmes. At that time, a total of 9 cases had been reported, 6 of which occurred after conventional surgical circumcision, and 3 following use of the elastic collar compression device method.

The experts reviewed in detail each male circumcision method, safety profiles, the pathogenesis and burden of tetanus infection, and different approaches to mitigating tetanus risk. The experts recognized limited coverage of tetanus toxoid-containing vaccination (TTCV) among adolescent and adult men. They recommended a dual approach to reducing tetanus risk through (1) good personal wound care and standard surgical skin preparation for all male circumcision methods, and (2) phasing in strategies to provide TTCV as relevant to their context, including at a minimum a single dose at the time of the procedure.

By May 2016, WHO had received reports through VMMC services of an additional 6 cases of tetanus, and convened a technical consultation on 3 June 2016 to consider the situation. A total of 12 cases had been reported since 2014 during the period of active monitoring. Of these cases, 6 were reported to have occurred following conventional surgical circumcision, and 6 following use of the elastic collar compression device method, which requires that the foreskin remain in situ for several days before removal.

Over the same active monitoring period, in countries reporting tetanus cases following VMMC, an estimated total of 3.04 million surgical circumcisions and an estimated 90 500 circumcisions with the elastic collar compression device were reported. As the safety profile regarding tetanus risk following the procedure with the elastic collar compression device method was considered different than originally assessed, and because the risk was considered higher than following surgical circumcision, the TAG revised its previous 2015 advice. Specifically, the TAG recommended risk reduction measures for adequate protection against tetanus, by immunization with TTCV, prior to the use of this device method. The advice on tetanus risk mitigation for other circumcision methods remained unchanged from the advice in the 2015 consultation report.

Additional consultation

WHO is convening a further expert discussion on 12 August 2016 to review additional documentation related to the safety of male circumcision methods. Following written submission of additional documentation, manufacturers and other interested parties will be provided the opportunity to present their position in an open session of the technical consultation. This will be followed by a closed session of the TAG members who will consider whether the additional documentation submitted warrants any change in the TAG's previous recommendations. The final report of the consultation is expected to be issued in September 2016.

Interested parties are requested to submit additional documentation, by 3 August 2016, 12:00, CEST to hiv-aids@who.int. Any material that should be treated as confidential should be clearly marked as such.

Any parties interested in presenting their position during the TAG's open session should submit a written request, including a description of their interest in the subject, by Monday 8 August 2016, 12:00 CEST to hiv-aids@who.int.

The additional documentation submitted by interested parties will be provided to TAG members and, with the exception of any confidential information/data, posted on the WHO website.

The open session of the consultation will be held by teleconference on Friday 12 August 2016, 14:00 - 15:30 CEST. Each interested party will have a maximum of 15 minutes to present its position. Depending on the number of parties requesting to speak, the amount of time allotted to each speaker may be revised. In any event, the time allotted to each speaker will be the same.

The TAG's open session of the TAG will be followed by a closed session, limited to TAG members only.

As noted above, the final report from the consultation is expected to be issued in September 2016.