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Page 4 of 9  Original Research


              provided a regression for participation is correctly specified
                                                                             577
              and no unobserved correlates of non-participation and risky   Par cipants screened for
              sexual behaviour exist. Inverse probability weights for   eligibility* 14 Nov 2013 –
              participation at follow-up were constructed from a         06 October 2015
              multivariable logistic regression model, which considered the             22 (4%) Not sexually ac ve
              following 24 potential covariates based on subject-matter                 1 (< 1%) HIV-posi ve
              knowledge: age, relationship status, religious affiliation,
              education, employment status, household assets or                         1 (< 1%) Aged < 18 years  or > 49 years
                                                                                        27 (5%) Resided outside study area
              characteristics, reason for circumcision, correct knowledge of            (> 25 km from clinic)
              circumcision benefits, beliefs about circumcision, alcohol use,           5 (1%) Not interested in study par cipa on
              age at first sex, number of sexual partners (past 1 month,   523 (91%)
              1 year and lifetime) and transactional sex. We also created 117   Eligible par cipants
                                                                         enrolled in study
              two-way interaction terms by taking the cross-product of each             4 (1%) Not circumcised due to medical
              demographic and socioeconomic covariates with each                        contraindica ons and withdrawn from study
              knowledge, belief and behavioural covariate. To build the                 10 (2%) Refused baseline sexual behaviour
              multivariate logistic regression model required by inverse-               ques onnaire
                                                                           509 (97%)
              probability weighting, we used a stepwise, forward selection   Circumcised par cipants
              procedure to identify covariates from the list of candidate   eligible for follow-up and
              predictors listed above. The entry and exit criteria were set to   completed baseline sexual
              a p < 0.2. We included missing indicators for each selected   behaviour ques onnaire
              variable to maximise the number of cases included in the final            105 (21%)
                                                                                        Did not aend three month follow-up visit
              models and to maintain a constant sample size across analyses.
                                                                                        36 (7%)
                                                                                        Aended three month follow-up visit
              In post-hoc analyses, we sought to identify attitudes, beliefs   368 (72%)  but refused sexual behaviour ques onnaire
              and/or behaviours reported at baseline that may be      Aened follow-up visit and
                                                                         completed sexual
              predictive of engagement (irrespective of what the participant   behaviour ques onnaire
              reported at baseline [i.e. pre-circumcision]) in high-risk   at three months
              sexual behaviour at 3 months post-VMMC. Specifically, we   Note: *, Two particpants did not meet two eligibility vriteria. Therefore the number and
              fit separate univariable- and multivariable-adjusted modified   percentages presented for invidual reasons for ineligibility will sum to > 100%.
              Poisson regression models (weighted by the inverse of the   FIGURE  2:  Consolidated  Standards  of  Reporting  Trials  (CONSORT)  diagram
                                                                    illustrating screening, eligibility, enrolment and follow-up of men undergoing
              probability of participation at follow-up) for each of our   voluntary medical male circumcision in Gaborone, Botswana, 2013–2015.
              primary outcomes (with the number of sexual partners in the
              past 1 month dichotomised at two or more) for each of the   included not sexually active (4%), residence outside of the
              following  covariates:  alcohol  consumption,  reasons  for   area (5%), HIV infection (< 1%) and age < 18 years or > 49
              circumcision, correct knowledge of circumcision benefits,   years (< 1%). Four individuals who met study eligibility
              beliefs about circumcision, age at first sex and transactional   criteria  and consented to study  participation were not
              sex.  All multivariable models were adjusted for potential   circumcised because of medical contraindications that were
              confounding by the following demographic and          identified before the procedure.  Amongst the 509
              socioeconomic covariates (all assessed at baseline): age,   circumcised participants who completed the baseline sexual
              relationship status, religious affiliation, education,   behaviour questionnaire, 368 (72%) attended the follow-up
              employment and household use of wood as cooking fuel.  visit and completed the sexual behaviour questionnaire at
                                                                    3  months post-circumcision. Because of  missing data  on
              All analyses were conducted by using SAS software version   specified outcomes, 353 were included in the analysis
              9.4 (SAS Institute, Cary, NC).                        examining the number of sexual partners in the past month,
                                                                    and 311 were included in the sexual concurrency analysis.
              Ethical consideration                                 Table 1 shows the summary of the baseline characteristics of

              Ethical approvals were obtained from the Health Research   the study population according to the availability of sexual
              and Development Committee at the Botswana Ministry of   behaviour data at 3 months post-circumcision. Men who
              Health  (MOH)  (#00699)  and  the University  of Washington   either did not complete the follow-up visit (n = 105) or refused
              Institutional Review Board (#42047).                  the sexual behaviour questionnaire (n = 36) were more highly
                                                                    educated (odds ratio [OR]: 1.72; 95% confidence interval
              Results                                               [CI]:  1.13–2.61) and underwent circumcision for personal
                                                                    hygiene reasons (OR: 1.66; 95% CI: 1.07–2.57) compared with
              Between November 2013 and October 2015, research staff   respondents at 3 months post-VMMC. In contrast, non-
              screened 577 men preparing to undergo VMMC for study   respondents were less likely to live in larger households
              participation (Figure 2). A total of 528 (92%) participants   (OR: 0.59; 95% CI: 0.36–0.97). No other baseline characteristics
              were determined to be eligible for participation and   were significantly associated with the response at 3 months
              523  (91%) subsequently enrolled. Reasons for ineligibility   post-VMMC.

                                           http://www.sajhivmed.org.za 149  Open Access
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