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Page 2 of 9  Original Research


              by  circumcision. This phenomenon, known as risk      Study setting and participants
              compensation  or  behaviour  disinhibition,  may  reduce  the   Adult men undergoing VMMC through the National Safe
              effectiveness of VMMC in preventing new HIV infections.   Male Circumcision programme were enrolled between
              Although RCTs conducted in Kenya and Uganda indicated
              that risk compensation behaviour did not increase following   November 2013 and  April 2015 at two government-run
                        9
              circumcision,  a RCT conducted in South Africa documented   clinics providing free circumcision services in Gaborone,
              a  higher number of sexual contacts amongst circumcised   the  capital city of Botswana. Participant eligibility criteria
              men compared with uncircumcised  men in the control   included: age ranging 18–49 years, residence within 25 km
              group.  However, amongst recent cross-sectional surveys   of Gaborone, ever had sexual intercourse and documented
                   1
              conducted in South Africa, Uganda and Kenya, there was no   HIV-negative test result. All participants provided written
              evidence that circumcised men’s behaviour was riskier than   informed consent for participation in the study in addition
              uncircumcised men’s behaviour. 10,11,12               to  the consent obtained by clinic staff for the circumcision
                                                                    procedure.
              Men circumcised in non-clinical trial settings may also
              encounter different experiences and behave differently.   Sample size
              However, little is known about how sexual behaviour   For study planning purposes, we computed sample size
              changes in real-world settings, as there have been only two   requirements (and corresponding power) based on the
              studies that examined men’s sexual behaviours before and   dichotomous outcome and engagement in concurrent sexual
              after undergoing VMMC. 13,14  Although the two studies, both   partnership(s) during the previous 3 months. We used
              conducted in South Africa, found minimal or no evidence   McNemar’s test for two correlated proportions to determine
              of  risk compensation, no studies have examined risk   the number of participants enrolled and the corresponding
              compensation in Botswana, where the rate of multiple and   power to detect the smallest, clinically meaningful difference
              concurrent sexual partnerships is particularly high. Recently   in the proportion of men who report engaging in a concurrent
              published findings from a large population-based sample   sexual partnership between baseline and 3 months
              found that 31% of sexually active adults in Botswana had   post-circumcision.   Figure 1 shows the summary of the
                                                                                  17
              concurrent sexual partners in the past year. 15
                                                                    proportions associated with all possible responses under this
                                                                    framework.
              We  conducted  a  prospective  cohort  study  amongst  men
              aged 18–49 years undergoing VMMC in Botswana to
                                                                                      FU
                                                                               B
              evaluate the changes, if any, in the frequency of high-risk   Specifically,  P  and  P  represent  the  total  proportion  of
                                                                    individuals reporting high-risk sexual behaviour at baseline
              sexual  behaviour  following  VMMC,  including  the  total   and follow-up, respectively;  P  and P  represent the
              number and  timing of sexual partnerships during the   proportion of individuals who increase or decrease their
                                                                                                      10
                                                                                              01
              previous 3 months.
                                                                    high-risk sexual behaviour between baseline and follow-up,
              Methods                                               respectively. We explicitly chose to test a one-sided alternative
                                                                    that high-risk sexual behaviour increases at follow-up (as
              Study design                                          opposed to the two-sided alternative of any change) to reflect
                                                                    the  conceptual  definition  of  risk  compensation.  Thus,
              This clinic-based prospective cohort study was designed to
              assess (1) the frequency, type and severity of adverse events   assuming a baseline prevalence of sexual concurrency (P )
                                                                                                                   B
                                                                          18
              immediately following VMMC; (2) the prevalence and    of  19%,  10% were unable to undergo VMMC because of
                                                                    medical or other contraindications and 20% were lost to
              correlates of re-initiation of sexual activity and (3) changes
              in  risky sexual behaviour following VMMC. The current
              analysis  reports  on  the  third  primary  objective.  The  study         Follow-up
              was conducted by the International Training and Education           Yes               No
              Center  for Health  (I-TECH),  a collaboration  with  the
              University of Washington and the University of California,
              San Francisco. Recruitment and enrolment of study                   P                 P          P
              participants  occurred before undergoing VMMC, but  after   Yes      11                10         B
              individuals  completed  group education  and individual
              counselling  with clinic  staff (including  HIV testing)  and   Baseline
              provided written, informed consent for the procedure.
              Neither the pre-procedure activities described above nor the        P                 P          1 – P
              procedure itself was performed by study staff. The overall   No      01                00           B
              objective of Botswana’s National Safe Male Circumcision
              programme is to reach a male circumcision prevalence rate of
              80% amongst 0–49-year-old HIV-negative males. A complete            P FU             1 – P FU
              description  of the  programme, including  details  on  the   FIGURE 1: Contingency table used for calculating power based on McNemar’s
              procedure itself, can be found elsewhere. 16          test of two correlated proportions.

                                           http://www.sajhivmed.org.za 147  Open Access
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