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Page 3 of 9  Original Research


              follow-up, power was estimated to be > 80% to detect a 5%   Participants received BWP100 (approximately USD$8 at
              increase in the proportion of men who engage in high-risk   study initiation) at each post-operative visit as compensation
              sexual  behaviour  at  3  months  post-circumcision  (relative   for their time and travel costs.
              to  baseline)  based  on a  sample  size of  523 participants.
              Power was estimated to be 99% for a 10% increase at 3 months   The current analysis is restricted to data collected at baseline
              post-VMMC.                                            and the 3-month follow-up visit when the sexual behaviour
                                                                    questionnaire was repeated. Study data were collected and
              Measures                                              managed by using Research Electronic Data Capture
                                                                    (REDCap), a secure, web-based application designed to
              In addition to the primary endpoints, the baseline    support data capture for research studies hosted at the
              questionnaire also collected information on demographics   Institute for Translational Health Sciences at the University
              (age, current relationship status and religious affiliation),   of Washington. 20
              socioeconomic indicators (education, employment status,
              electricity in household, refrigerator in household and use   Outcomes
              of wood as cooking fuel), frequency and intensity of alcohol
              consumption, age at sexual initiation and history of   The primary outcomes of the current analysis were (1) the
              transactional  sex. We  also collected  information  on  the   number of sexual partners in the previous 1 month and (2) one
              primary reason for getting circumcised (i.e. protecting against   or more concurrent sexual partnerships during the previous
              HIV, personal  hygiene or  other),  whether  the participant   3  months.  In  accordance  with  the  Joint  United  Nations
              believed circumcision would have a negative, positive or   Programme on HIV/AIDS (UNAIDS) recommendations, we
              no  impact on the quality of sex, and administered a four-  defined a concurrent sexual partnership as ‘overlapping
              question scale developed in South Africa to assess attitudes   sexual partnerships in which sexual intercourse with one
              towards condom use, monogamy and HIV risk in the context   partner occurs between two acts of intercourse with another
                                                                          21
              of circumcision.  Lastly, we constructed two indicators   partner’.  Concurrency was then assessed by using the
                           19
              evaluating the accuracy of participants’ knowledge regarding   following three questions (based on UNAIDS recommendations
              the effect of VMMC on female-to-male and male-to-female   for data collection), each of which was asked of participant’s
              HIV transmission. Specifically, we classified men as having   three most recent sexual partners: ‘How long ago did you first
              correct knowledge if they indicated that VMMC  partially   have sexual intercourse with this person?’ ‘When was the last
              protects a man from getting HIV from a woman but does not   time you had sexual intercourse with this person?’ and ‘Are
              affect a woman’s chances of getting HIV from a man.   you still having sex with this person?’

                                                                    To evaluate the change in the number of sexual partners and
              Data collection                                       engagement in concurrent sexual partnerships before and
              Before undergoing circumcision, all study participants were   after undergoing VMMC, we constructed change scores for
              asked to complete a baseline sexual behaviour questionnaire   each endpoint, which subtracted participants’ baseline
              through an audio computer-assisted self-interviewing   response from that reported at the 3-month follow-up
              (ACASI) tool in a private office room at the study site. This   interview.
              interviewing technique circumvented Social Desirability bias
              by allowing the participant to complete the questionnaire in a   Statistical analyses
              standardised format without having to share their responses   For the continuous outcome, the number of sexual partners
              with study personnel directly. However, if the participant was   (past 1 month), we fit an intercept-only inverse-probability
              unable or preferred not to use the ACASI tool, the study nurse   weighted linear regression model to estimate the mean
              was available to administer the questionnaire. The tool,   change in the number of partners at 3 months post-VMMC
              available in both English and the local language, Setswana,   (compared to baseline). For the dichotomous outcome,
              was developed by using Questionnaire Development System   engagement  in  concurrent  sexual  partnerships  (past  3
              (QDS ) questionnaire and survey development software   months), we fit an inverse-probability weighted conditional
                  TM
              adapted for low literacy and computer naïve populations   logistic  regression  model  (stratified  on  the  participant)
              (Nova Research Company, Silver Spring, MD).           to  estimate the change in the proportion of participants
                                                                    reporting  sexual concurrency at 3 months post-VMMC
              After circumcision, post-procedure visits at 2 days, 7 days,   (compared with baseline).
              6  weeks and 3 months were scheduled as outlined by the
              Botswana Ministry of Health (MOH) guidelines for adult   Inverse probability weighting was used to adjust for potential
              VMMC. At each visit, participants completed the follow-up   selection bias because of non-trivial (anticipated to be 20%
              survey through  ACASI during their clinic appointment.   before study start) loss to follow-up. 22,23,24  Inverse-probability
              A  follow-up visit at 12 months was planned to coincide   weighting  adjusts  for loss  to follow-up  by empirically
              with annual HIV testing as per standard of care in Botswana.   breaking the association between observed predictors
              Each study participant was provided with a wallet-size   (collected  at  baseline)  and  participation  at  follow-up,
              reminder  card  noting  the  date  of  each  follow-up  visit.   allowing  for unbiased  estimation in the  weighted  sample,

                                           http://www.sajhivmed.org.za 148  Open Access
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