Male Circumcision for the prevention of heterosexual transmission and risk compensation in Soweto: What do indictaors and incidence show? v1

Three clinical trials were conducted in Africa to determine the efficacy of male circumcision in preventing heterosexual transmission of HIV. They were done in, Rakai in Uganda [1], Kisumu in Kenya [2] and Orange Farm [3] in South Africa. These trials contributed immensely to the decision taken by UNAIDS/WHO to include male circumcision as part of HIV transmission prevention measures [4]. There are several significant differences in, not only the methodology of all the three clinical trials but also with the way mass male circumcision has been implemented as a means of preventing heterosexual transmission of HIV. The implementation of mass male circumcision for prevention of heterosexual transmission of HIV is in a setting of service delivery. Whilst trial participants had repeated HIV prevention counselling, in the implementation this is provided only at the time of the procedure. During implementation most do not come back past the second day post circumcision follow up. Thus, after the circumcision no data are available to show what happens to patients past the once off counselling. On the other hand, the 60% protection from the “intent-to-treat” analysis of the Orange farm trial could be said to be too conservative. This is so because as “per protocol” analysis, which addressed the 10.3% of men allocated the non-intervention arm who got themselves circumcised outside the study, the relative risk among these was 0.24, which translates to a effect of 76%.[5]. If this finding were to be verified then the circumcision protective effect will be as high as some vaccines. In response to the concerns raised about the Orange farm clinical trial, the authors of the trial mentioned that: “The magnitude of the effect in a trial of this nature can not, in any case predict precisely what to expect in the actual intervention for four reasons. Firstly, the trial was conducted in a specific population (young men of the age range 18–24 years); it was not representative of the whole population. Secondly, the participants received intense counselling periodically throughout the follow-up period. Thirdly, they were informed that the result of the trial was unpredictable. Finally, the duration of the follow-up period was short. This is why operational research should be conducted to test if male circumcision, in association with existing and validated prevention methods, can be used in community intervention.”[6] This study will be the first to address these questions, as it will be based on the mass male circumcision implemented under operational conditions. General Study Objective To determine the effectiveness of mass male circumcision in prevention of HIV acquisition among male adults in Soweto. Specific Objectives: 1 .To determine the incidence of HIV in circumcised males aged between 18-40 years of age in a mass male circumcision setting. To determine the demographic and sexual characteristics of HIV negative males aged 18-40 years who seek circumcision. To determine the risk factors associated with HIV sero-conversion among circumcised males aged 18-40 years. To determine the presence or absence of risk compensation post circumcision, Study Design The study will be a prospective cohort design. Clients seeking circumcision will, upon providing consent, be enrolled in to the study. All will be provided with HIV counselling and testing as is currently the norm. A questionnaire will be administered by trained interviewers, prior to the circumcision. Two days post circumcision they will be seen to check for any surgical complications as is currently being done in routine practice. There are follow-up visits that will be scheduled for 3, 6 and 12 months post circumcisions. At these visits a questionnaire will be administered as well as an HIV test done. The main outcome variable to be collected will be the HIV status. This will be done by rapid HIV tests as is currently being done. The outcomes will be HIV positive, negative or indeterminate. However, only positive and negative will be included in analysis. The other outcome variables will be indicators of risk of HIV as determined by risk behaviour. These and other variables will be collected by way of an interviewer administered questionnaire. This will be administered at entry and all the subsequent follow-up visits. These variables will collect data on Demographic, Behavioural, Psychological and Biological risk factors for HIV. Data relating to adverse events will be collected by way of both questionnaires and physical examination, to be done by the investigator. Dr Neil Martinson will be the mentor to Dr Mukudu who is the applicant and will be the principal investigator. Dr Mukudu will be responsible for making sure data is collected in a highly scientific standard. To do this he will in addition to other things, do the following: conduct pilot study to test recruitment procedures and study tools, train all data collection staff, undertake continuous monitoring of data for errors and check all data for completeness before entry. Most of the provisions required for conducting the study will be provided by Perinatal HIV Research Unit except transport refund for the follow-up visits, telephone costs and stationery. It is for these aspects of the anticipated expenditure that funding is being sort from Canada-Africa prevention trials network. Sample Size Estimation The sample size will be 904 men, with 452 in the 18-24 yrs group and the other 452 in the 25-40 yrs group. This is calculated using the sample size calculation for single population proportion at 5% precision and accounts for 15% loss to follow-up in each group. This assumes a proportion of 0.5%. Ethical Considerations Ethical approval will be sought from Human Research Ethics Committee at Wits University in South Africa, before starting the study. Consent forms will be signed by the participants only after full information about the purpose; requirements and demands of the study have been explained and understood. They will be informed that they are free to withdraw their consent at any time during the study and that the decision will not influence how they are treated. They will also be provided with contact details of research regulatory bodies in case of a complaint against the conduct of the study. While maintaining that participants will not be induced to participate, a small reimbursement for the inconvenience, time and travel costs will be given. Confidentiality of the participants’ records will be maintained through out the study. Participants who seroconvert during the study will have a CD4 count done, and then referred for appropriate treatment. Limitations The main limitation of the study will be follow-up. This is so because of the nature of the study, a cohort of almost 904 participants. Thus it is anticipated that some will be lost to follow-up. Another limitation is that since the study will not have a comparison arm of uncircumcised men, it will not be possible to accurately estimate the effectiveness of medical male circumcision. However, this will be deduced by comparing HIV incidence rates with the intervention arm of the Orange farm trial as well as other groups of HIV intervention strategies.

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